MAT# 12809912
Injured minor (DOB 1/4/2022) underwent an attempted PDA closure on 5/17/2022 at a children’s hospital. Birth history noted as C-section with normal APGARS. Outpatient pediatric records reflect murmur documentation issues. Weight trajectory shows 2.72 kg at birth and approximately 5.32 kg at the time of the PDA closure attempt (documented as ~4 months old, 5.32 kg; additional weights: 6/4/2022 5.47 kg; 6/16/2022 5.69 kg; 10/21/2022 6.45 kg).
Event log/procedure summary (***please see attached redacted procedure notes***)
Patient was ready for procedure at 07:57, anesthesia began 08:36, procedure started 09:29, and heparin was administered at 09:38. A quick note at 10:31 indicates the surgical team was to be notified that the PDA device was in the main pulmonary artery. At 10:33, the record documents ventricular fibrillation with the device in the MPA, initiation of CPR, defibrillation attempts, and activation of ECMO; a subsequent note reflects ECMO via central cannulation with CPR stopped around 11:06, followed by cardiopulmonary bypass and an aortic cross-clamp period (approximately 12:28–12:47), with the overall procedure/surgery ending later that afternoon. A Code Blue note provides a parallel sequence for ECMO initiation (prep beginning ~10:47; sternotomy ~10:59; cannulation complete ~11:04; ECMO start/CPR stop ~11:06)
Post-event neuroimaging includes MRI findings on 5/20/2022 describing bilateral hippocampal diffusion restriction favored as postictal change (no acute ischemia), thin subacute extra-axial blood over the right parieto-occipital/posterior temporal region, and multiple microhemorrhages; a 5/23/2022 head ultrasound notes persistent seizures/small head bleed history, without definite intraparenchymal hemorrhage on sonography and without hydrocephalus.
In September 2022, IP was Dx with anoxic brain injury with continued seizure disorder and other complications.
Principal allegations are that the interventional equipment used for the PDA closure attempt was an AMPLATZER Duct Occluder (ADO I) device and not the recommended Piccolo version. The core concerns flagged in this case are that ADO I labeling lists contraindications for patients <6 kg and <6 months, and the child was approximately 5.32 kg at the time of the procedure; in addition, there’s an allegation the device was mis-sized relative to the duct measurements.
Does improper sizing and/or unfavorable anatomy increase the risk of device malposition or embolization?
There is additional contention that the provider should have deferred closure until the child was larger? (asserted that the risks of waiting were not profound). The provider’s position is that the contraindication was “relative” and that the device was considered safe based on the physician’s prior experience and lack of previous complications.
We appreciate your time and welcome any questions.
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Do you believe there might have been medical error?
The decision to close a PDA in the cath lab vs surgical ligation is primarily based on symptoms or echocardiographic findings in relation to the size of the patient and what device would be the best fit. The use of an ADOI device is primarily reserved for larger PDA's especially in smaller patients based on the design of the device and the patients ductal anatomy vs an ADOII device. The use of a piccalo device in that patient size would never be used since this device is much softer with less radial force and is typically reserved for premature infants usually < 2kg . I cannot determine from this brief event summary as to why the closure was performed at this age and why an ADOI was selected. In depth review of the cath report and angiograms, would be necessary for a definitive determination of negligence. In addition, embolization of this device into the main PA should not typically result in cardiac arrest and the need for ECMO support unless the device had completely obstructed pulmonary blood flow which once again would be atypical unless the device selected was over sized and could not embolize into a branch pulmonary artery. A more extensive review of the medical records would be necessary in order to determine if there was any standard of care deviation
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
Same response as above The decision to close a PDA in the cath lab vs surgical ligation is primarily based on symptoms or echocardiographic findings in relation to the size of the patient and what device would be the best fit. The use of an ADOI device is primarily reserved for larger PDA's especially in smaller patients based on the design of the device and the patients ductal anatomy vs an ADOII device. The use of a piccalo device in that patient size would never be used since this device is much softer with less radial force and is typically reserved for premature infants usually < 2kg . I cannot determine from this brief event summary as to why the closure was performed at this age and why an ADOI was selected. In depth review of the cath report and angiograms, would be necessary for a definitive determination of negligence. In addition, embolization of this device into the main PA should not typically result in cardiac arrest and the need for ECMO support unless the device had completely obstructed pulmonary blood flow which once again would be atypical unless the device selected was over sized and could not embolize into a branch pulmonary artery. A more extensive review of the medical records would be necessary in order to determine if there was any standard of care deviation
What makes you a good expert for this case?
I have been practicing as an interventional pediatric cardiologist for 36 years and to date have closed about 500 PDA's in the cath lab utilizing numerous devices in patients of all ages and sizes (as small as 800 grams to adulthood)
How often do you encounter cases similar to this one in your practice?
I have infrequently experienced device embolization in PDA closure cases although usually the device migration does not lead to immediate cardiovascular symptoms and can typically be retrieved in the cath lab although at times open heart surgery and removal is necessary albeit rare
Do you believe there might have been medical error?
Based on the angiography description, the PDA was initially deployed (not released) and was entirely within the pulmonary artery. Then, repositioning of the device was by leaving the retention disc within the PDA. This device is intended to leave the retention disc within the ductal ampulla and not within the PDA. Likely during expansion, the device got "milked out" from the PDA into the right pulmonary arteries. Despite this, embolization of the device to one of the branch pulmonary arteries should not result in immediate ventricular fibrillation therefore, this makes me think the patient had a substrate for this. On the other hand, during CPR, the primary objective is to maintain cerebral perfusion. The time during chest preparation (cleaning, placing surgical fields) and exposing the heart it is time the patient did not receive chest compressions (therefore, no brain perfusion). Answering the questions: Piccolo device is not adequate for this size PDA and this size patient. Based on the description of the PDA size, the 8/6 ADO I was the right choice. Also, nowadays it is feasible to close the PDA at any age. I believe the age and/or size of the patient did not influence on the outcome.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
The patient did not receive chest compressions for the time the chest was being prepared and incised. Probably, neck cannulation would have allowed for less time without chest compressions.
What makes you a good expert for this case?
I perform PDA closures in patients from 650g to adults. In addition, I do percutaneous ECMO cannulation for ECPR.
How often do you encounter cases similar to this one in your practice?
Embolization of PDA devices occur and is well described in the literature. However, I have never heard of a patient going immediately to ventricular fibrillation secondary to embolization of a device.
Do you believe there might have been medical error?
1. Use of a Amplatzer Duct Occluder I was a very poor decision for a Type C ductus and likely contributed to the embolization. Most pediatric interventionalists would recommend a ADO II or an Amplatzer Vascular Plug 2. Both of these devices would also need to be significantly oversized vs the ductal diameters given. Stable device position in Type C depends on radial forces throughout the entire 11 mm ductal length, not narrowest dimenstion, as it does in the most common Type A ducti. 2. This is a borderline case for interventional closure. The patient's growth was described as slow, however 5.3 kg at 4 months given birth weight of 2.7 kg is normal weight gain. This procedure should have been delayed until the child was older and larger, making it lower risk.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
1. I believe that the device embolization precipitated a series of events leading to the patient's brain injury. Embolization with significant obstruction to the right pulmonary artery flow, led to reduced pulmonary venous return and ultimately to low cardiac output. With an baseline dilated left ventricle and moderate mitral regurgitation, this reduction was very significant and led to cardiac dysfunction, coronary ischemia and ventricular fibrillation. Although the patient was surgically rescued fairly expeditiously, it was not quick enough to prevent brain injury.
What makes you a good expert for this case?
1. Although I retired from practice 3 years ago, I had a long career as a very experienced and nationally known pediatric interventional cardiologist. I have closed hundreds of PDA's using coils, ADO I and II, Vascular Plugs and PIccolo devices 2. In addition, I have authored or coauthored some of the sentinel papers on coil and device PDA closure. 3. I retain the title of Professor Emeritus, UC San Diego, School of Medicine.
How often do you encounter cases similar to this one in your practice?
Because PDA devices have good control systems, embolizations are rare likely in the range of 1-2%. Furthermore, ventricular fibrillation and brain injury are very rare outcomes of device embolization. VF likely occurred because of the relatively more significant pulmonary artery obstruction caused by this device and the patient's relatively small size as well as the patient's baseline LV dilation and mitral regurgitation.
Do you believe there might have been medical error?
1. The procedure was clinically indicated as the patient had a significant PDA with"heart failure" (slow growth, diaphoresis with feeds), left ventricular dilation and right ventricular hypertension. 2. The case was appropriately discussed in a multidisciplinary conference and transcatheter treatment was recommended 3. While the device used is typically contraindicated in patients less than 6 kilograms, that really does not pertain to this type of PDA (Type C). With the most common PDA type (Type A) the device can result in aortic obstruction in infants less than 6 kilograms. With Type C PDAs the device is delivered within the PDA, as was carefully done in this case, and aortic obstruction is not a risk.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
I would characterize this as a complication, not an error. But, the brain injury occurred either when the patient was in ventricular fibrillation receiving CPR, while on ECO or in the operating room. None of those scenarios would have occurred absent embolization of the device. A question I have is whether the pt had an attempt at electrical defibrillation.
What makes you a good expert for this case?
I am an interventional pediatric cardiologist with 33 years of experience. I was an investigator in the Phase 3 trial of this device.
How often do you encounter cases similar to this one in your practice?
Transcatheter PDA closure is a fairly common procedure. I have probably closed more than 200 in my career
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