68 y/o male with history of right femoral to posterior artery bypass. Admit for Right lower extremity angiogram via LEFT CFA access on 5/31/22. Procedure start 1344 hours. Access gained into R iliac system using Van Schie 3 catheter. (Omni catheter would not pass). Advanced into PTA beyond distal anastomosis. Prior venous bypass graft cannulated. Balloon inflated distal then proximal. Wire and catheter moved into left iliac system. Completion angiogram showed improvement of anastomotic stenosis. Angio-Seal opened and deployed. Procedure end 1507. 1935 out of recovery. Rapid response called at Midnight for sudden drop in BP and altered mental status. 0319 in CT. CT terminated due to code. Pt to OR. Procedure start with incision at 0429. Finding: bleeding from LEFT external iliac artery in proximity to access site. Placement of viabahn stent for control of extravasation. Patient suffered from hemorrhagic shock and compartment syndrome. Code Blue called later that evening and patient pronounced at 9:35pm on 6/1/22.
Is laceration of left common iliac artery gaining access to right side a recognized complication or the result of technical error. Should laceration have been diagnosed before completion of procedure. What is explanation for 9 hour delay in sudden drop in BP.
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Q: Were there images of the access site taken during initial access? And does it look from the notes like the access was too high into the external iliac?
A: —
Q: Finally, was US used to gain initial access?
A: —
Do you believe there might have been medical error?
Based on the brief narrative, there is a possibility of an inaccurate puncture or high puncture under the inguinal ligament. It would be instrumental to see if an ultrasound was used for guidance as that is now essentially the standard of care. It seems that the bleeding was caused by the puncture site. Unclear the delay in diagnosis. It would be ideal to see what the patients vitals were doing in the interim, to see if there was anyway to identify this earlier. In my experience the blood pressure starts to drop and heart rate starts going up and usually there are signs before 9 hours.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
Based on the brief narrative, there is a possibility of an inaccurate puncture or high puncture under the inguinal ligament. It would be instrumental to see if an ultrasound was used for guidance as that is now essentially the standard of care. It seems that the bleeding was caused by the puncture site. Unclear the delay in diagnosis. It would be ideal to see what the patients vitals were doing in the interim, to see if there was anyway to identify this earlier. In my experience the blood pressure starts to drop and heart rate starts going up and usually there are signs before 9 hours. There could be telling information in the documentation that could reveal a delay in diagnosis.
What makes you a good expert for this case?
I am a board certified vascular surgeon that routinely performs angiograms for peripheral arterial disease. I have reviewed and consulted on many peripheral arterial cases before and would love to be of assistance if I can.. The key to any case will be in the details of the chart review to see what the patient was physiologically doing in the 9 hours between procedure and rapid response being called. Also if there was ultrasound used for the access.
How often do you encounter cases similar to this one in your practice?
quite frequently. I have just performed 5 lower extremity angiograms in the last week. We routinely cannulate the opposite groin for angiograms. Although I cant say we have no complications we like to believe we have multiple methods to ensure the procedure goes as safely as possible.
Do you believe there might have been medical error?
To briefly answer your question, these types of complications (access laceration and/or failure of the initial closure device that is the “AngioSeal” do occur and should have been managed in a more expedited fashion. Mitigating circumstances in this case include: - Where angiogram films obtained at the time of the procedure to assess the access point for its location and occurrence of calcium and/or atherosclerotic disease. Any one of these factors are known to contribute to the failure of any closure device and the eventual bleeding that occurred. - Work-up steps after the initial drop in the blood pressure. - What the training of the proceduralist, that is, was it initially a vascular surgeon who can handle the open and endovascular treatment of these types of complications. If not, was a vascular surgeon consulted and if so, when? - What is the stated policy and procedures as it pertains to the observation and subsequent management of the patient after this procedure? - Why was a CT scan undertaken? A hypotensive patient after this type of procedure is considered a bleed until proven otherwise, that is in the operating room
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
The close association of the procedure and subsequent finding on re-exploration indicates a strong causal link of the complication (bleeding) to the initial procedure and the delay in its diagnosis as well as treatment to the death of the patient.
What makes you a good expert for this case?
I undertake and/or oversee several of these types of procedures in my practice. I am called as the senior partner to aid my partners in handling these types of complications. My experience over 14 years has included managing angiogram complications in an open and endovascular fashion.
How often do you encounter cases similar to this one in your practice?
Our practice undertakes around 75 cases in a given year similar to the one described. Our current rate of access complications is similar to the literature, 3% hematoma and 1% bleeding [1]. I have personally undertaken these types of angiogram cases and have handled my own complications as well as from other proceduralists in. my medical center. I can speak not only based on my training but my experience the one described in the case and can speak to the diagnostic imaging, work-up, ICU stabilization and open/endovascular approaches to these types of patients. 1. Tavris D.R., Wang Y., Jacobs S., et al: Bleeding and vascular complications at the femoral access site following percutaneous coronary intervention (PCI): an evaluation of hemostasis strategies. J Invasive Cardiol 2012; 24: pp. 328-334
Do you believe there might have been medical error?
This determination will depend on site of access (external iliac is too high) and whether or not US (ultrasound) was used to achieve initial access.
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
If the access was too high, then yes, there is causation.
What makes you a good expert for this case?
I perform well over 500 of these endovascular procedures a year and have extensive experience in US guided access..
How often do you encounter cases similar to this one in your practice?
Many times a year. Perhaps not with such drastic outcomes, but I suspect the delay in presentation was due to a late failure of the closure device with subsequent hemorrhage.
Do you believe there might have been medical error?
The bleeding itself post-access is a known complication of the procedure. However, if the patient had a drop in mental status at midnight, there should have been more rapid recognition of the bleeding complication. Bleeding is likely from this type of access and diligence is needed to monitor the patient postoperatively for bleeding complications. The midnight changes in mental status should have prompted an earlier CT scan, not one at 3 am. Then, once the bleeding complication was noted. it should have been acted on quickly. It seems as though it was. However, another 15 hours passed before the patient expired, and it was noted that the patient had compartment syndrome. Was this operated on? It should have been. Also, his coagulopathy should have been corrected within a few hours in an hospital with massive transfusions capabilities, Why was this not done?
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
Again, I believe the medical error here is not to have high enough suspicion of injury and complication and the subsequent care. There is a technical error with the access site bleeding but it's difficult to implicate this, as it is a known complication of the procedure and - should have been - discussed with the patient before the procedure as a potential complicaiton.
What makes you a good expert for this case?
I am an ICU intensivist who manages the complications of vascular procedures. I'm a general and trauma surgeon who also does open vascular surgery. I have managed abdominal compartment syndrome, hemorrhagic shock and coagulopathy. I have over 12 years experience at Level 1, academic medical centers.
How often do you encounter cases similar to this one in your practice?
I take care of vascular patients daily to weekly, and manage the complications of endovascular procedures about once a month. I manage compartment syndrome patients several times a month and patients with hemorrhagic shock several times per week.
Do you believe there might have been medical error?
Bleeding from endovascular access site is a recognized complication, but may be due to technical error. The bleeding may have been caused by failure of Angio-Seal closure device, misdeployment of closure device, or high puncture resulting in access above inguinal ligament which would cause closure device to fail. Bleeding from external iliac artery by definition is above the inguinal ligament, meaning the access site was too high. The laceration may not have been diagnosed before completion of the procedure if it was a result of failure or misdeployment of closure device. The 9 hour delay in sudden drop in BP suggests progressive ongoing bleeding resulting in sudden hemodynamic collapse. A drop in BP from hemorrhagic shock would likely be preceded by tachycardia (increased heart rate). It begs the question of whether the patient was complaining of groin pain and whether the patient and vital signs were adequately monitor by nursing staff and if physician was notified of any tachycardia prior to cardiovascular collapse. It is also unclear why there is also a delay of 3 hours from rapid response at midnight to CT being done at 3:19am. Also, why was Viabahn covered stent deployed for control of bleeding rather than direct repair of the artery? The access site bleeding is a known complication. However, the complication should not have resulted in hemorrhagic shock progressing to death if the patient was properly monitored, the clinical signs of bleeding recognized (tachycardia, groin hematoma), urgent CT imaging completed, and prompt treatment rendered (direct surgical repair in OR).
Do you believe there might have been causation (i.e. the medical error resulted in an injury)?
Access site bleeding is a known complication, but progression to hemorrhagic shock and death is unusual.
What makes you a good expert for this case?
I am a board-certified vascular surgeon who has repaired closure device complications: bleeding from high access site (above inguinal ligament in external iliac artery), pseudoaneurysms, and intra-luminal deployment of Angio-seal device leading to arterial thrombosis and acute limb ischemia.
How often do you encounter cases similar to this one in your practice?
Access site complications a few times a year.
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