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.
Files:
No questions yet!
Do you believe there might have been medical error?
Two issues are at stake here: 1] appropriateness of the device chosen. Utilizing an ADO is not apparently contraindicated, and waiting longe for the "child to be bigger" would not have made a difference (PDA occlusion is done with Piccolo devices all the way down to neonates < 1 Kg). As far as appropriateness of sizing, one would have to look at the records and see what a reasonable and prudent clinician would have done under similar circumstances. 2] Is there Negligence? Most likely not. Device embolization is a known complication of the procedure, with sequelae varying according to location of the device, inability to retrieve it etc. etc. In this case the device occluded the main pulmonary artery, with an effect similar to a massive pulmonary embolus, with inability to oxygenate the patient and maintain an adequate cardiac output. In addition, the timing between dislodgement, ventricular fibrillation and calling for ECPR is brief, indicating the seriousness of the device position and a rapid response. Lastly, there is no negligence whatsoever on the part of the surgical team, with a prompt response and very reasonable time from ECPR call and initiation of cardiopulmonary bypass.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
causation is fairly straightforward (see above). Clearly the Anoxic brain injury occurred because of the location of the device embolization. If the device had embolized in one of the branches or even in the descending aorta it could have been retrieved percutaneously and/or at least the patient would have had a higher likelihood of having hemodynamic stability in anticipation of surgical intervention
What makes you a good expert for this case?
I am a board-certified cardiothoracic surgeon with subspecialty certification in congenital cardiac surgery, with 23 years of experience post-training. I have retrieved a fair amount of embolized devices in my career and have substantial medico-legal experience
How often do you encounter cases similar to this one in your practice?
5 cases (at least). i have retrieved devices from the left heart, aorta, pulmonary artery and right ventricle
Do you believe there might have been medical error?
Use of ADO was against contraindications without contemporaneous documentation of either anatomic or other medical need to justify its use. Ironically this large duct would be a reasonable justification for ADO over the piccolo. ADO I device was undersized for use in ‘large’ type c duct with operator measurements of 7.7 aorta and 6 mm PA. Would typically require a 10/8 minimum and long tubular type c PDA would better accept the longer device profile. 8/6 was used to apparently bury the device to clear the aorta but its short and 7.7mm PDA diameter and 8 mm device profile lack sufficient purchase. This accounts for it tumbling out of the PDA into the PA. Typically operator would select at least 2 mm larger than the largest dimension of duct. Note: I don’t perform these procedures.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
ADO I device was undersized for use in ‘large’ type c duct with operator measurements of 7.7 aorta and 6 mm PA. Would typically require a 10/8 minimum and long tubular type c PDA would better accept the longer device profile. 8/6 was used to apparently bury the device to clear the aorta but its short and 7.7mm PDA diameter and 8 mm device profile lack sufficient purchase. This accounts for it tumbling out of the PDA into the PA. Typically operator would Typically operator would/should select at least 2 mm larger device than the largest dimension of duct.
What makes you a good expert for this case?
Unfortunately I do not perform PDA device closures.
How often do you encounter cases similar to this one in your practice?
I have encountered the need to retrieve 3 devices after displacement from PDA occlusion in the lab - both in the aorta and the PAs.
Do you believe there might have been medical error?
Device migration is a known complication of PDA device placement. The specifics of the device should be addressed by a pediatric Cardiologist/interventionalist Once the device migrated the congenital cardiac team did a great job at establishing ECMO Support in a timely fashion A few point I would raise that may come up throughout the review. There was an opportunity to place the patient on ecmo peripherally through the neck. Also once the patient was supported on ecmo, either peripherally or centrally, there was also an opportunity to retrieve the device with a catheter based intervention. This could have avoided a sternotomy, but more importantly could have avoided full heparinization, cardiopulmonary bypass and crossclamp. These all subjected the patient to potentially avoidable risks, especially given the recent arrest event
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
I do not believe there was necessarily a medical error. Again device embolization is a known risk of PDA device closure. That being said the migration of the device likely led to the subsequently arrest and need for ecmo support. It is unclear as to the exact etiology of the neurologic event - the device in the main pulmonary artery, the arrest, the ecmo, the subsequent operation, etc…
What makes you a good expert for this case?
I have been a practicing congenital heart surgeon for over twenty years. Much of that time has been at one of the largest programs in the country. I have done numerous case reviews on both the plaintiff and defendant side. Being able to see the case from both sides is important, as it allows the team to anticipate issues that may be brought up from both vantage points I am very responsive and can review cases in a very timely fashion
How often do you encounter cases similar to this one in your practice?
This particular event is common but does not usually lead to an adverse event. Most often the device migration is inconsequential and the device is retrieved by the interventional Cath team I have reviewed over 30 cases that truly cover the full spectrum of congenital heart pathology
Want to open a case or submit response?
Comments are accepted only from Cardio-Thoracic Surgery experts.