MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number ZFEN-P-2-28-109

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Zfen-p-2-28-109, device was prepped and oriented, as per instruction for use (ifu).The scallop and renal fenestrations were orientated, as per the clock faces provided on the plan.Renal arteries were cannulated in 15 minutes and stented, as per ifu.Trackability of wires, catheters and sheaths were smooth and no issues were present.Then, injector run was conducted, as per ifu to assess the flow to vessels before moving onto the zfen-d-12-28-76, device and limbs.Superior mesenteric artery (sma) had normal flow as did the renal arteries.The case was continued with the bifurcated graft and 2x limbs, as per ifu with nil issues.However, the final run showed minimal flow to sma and doctor queried the shuttering of the sma.It was decided, that the sma should be stented.And it was challenging to get access to sma vessel.The 0¿18 wires and o¿35 cxi catheter were used to cross into the sma.Tracking the stent also proved challenging.But eventually, the stent was in place and deployed with nil issues.And the final run should flow to sma and renal¿s with nil issues.

Manufacturer Narrative

No part of the device was returned for evaluation; therefore, no visual inspection or functional testing could be performed.Imaging was supplied and reviewed by the medical director who stated "the zfen-p had been deployed successfully and quickly, with good stenting of both renal arteries.When the zfen-d had been deployed, the next angio run showed that the sma flow was minimal (had been excellent on the previous runs).It was assumed that this was due to shuttering, despite the two renal stents tendency to prevent any rotation of the zfen-p, and they decided to stent the sma through the scallop.This was done with some difficulty but was successful in restoring good flow into the sma.This is all confirmed on the angio run imaging we have, but of course we can¿t tell if shuttering was the actual cause of the sma reduced flow.That does remain the most probable cause.The next day, the follow-up ct was done, and this showed that the l.Renal artery had occluded ¿ i can confirm that on the ct scan.However, i can see no cause for the renal artery occlusion ¿ on the angio run the previous day, the renal arteries looked to be mildly diseased but with no obvious stenosis, and the left renal artery in particular looked to be quite smooth, with a well-functioning bridging stent.I could postulate that maybe the patient had a period of hypotension, for example, and that this may have contributed to a spontaneous occlusion of the l.Renal artery, but that would be pure speculation.I can¿t see any fault or failure of any of the device components.The possible shuttering of the sma, if correct, would have been a procedural problem with slight rotation or upwards movement of the sma scallop while placing the zfen-d.The l.Renal artery spontaneous occlusion may be related to the patient¿s condition or the reaction to the bridging stent, but i don¿t see this as a fault or failure of our device" review of the device history record (dhr) for work order (b)(4) found that the work order appeared complete, and the quality control inspection was verified to ensure that the device passed inspection.Upon reviewing the photos taken of the complaint device during manufacture it appears that the device was manufactured as per specifications.Review of instructions for use (ifu) supplied with the device for general information was found to contain appropriate warnings, precautions, and instructions to the user, including: 4.2 patient selection, treatment and follow-up inability to maintain patency of at least one internal iliac artery or occlusion of an indispensable inferior mesenteric artery may increase the risk of pelvic/bowel ischemia.4.3 implant procedure inaccurate placement and/or incomplete sealing of the zenith fenestrated aaa endovascular graft within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the renal or internal iliac arteries.Renal artery patency must be maintained to prevent/reduce the risk of renal failure and subsequent complications unless medically indicated, do not deploy the zenith fenestrated aaa endovascular graft in a location that will occlude arteries necessary to supply blood flow to organs or extremities.Do not cover significant renal or mesenteric arteries (exception is the inferior mesenteric artery only if the superior mesenteric artery and the anastomosis of riolan are patent and functioning correctly) with the endoprosthesis.Vessel occlusion may occur.5 potential adverse events use of the zenith fenestrated aaa endovascular graft poses the following potential risks in addition to those associated with use of a standard zenith endovascular graft: organ impairment/loss due to side-branch vessel occlusion (in particular, renal and/or gastrointestinal impairment/loss).Other adverse events that may occur and/or require intervention include, but are not limited to: graft or native vessel occlusion there is no evidence to suggest that the user did not follow the instructions for use.Based on the information and medical director's assessment, it is most likely that there was a procedural problem when placing the graft (zfen-d) which caused the slight rotation or upwards movement of the sma scallop and therefore, the inadvertent blockage of the required artery (sma).The appropriate individuals will continue to monitor for similar complaints.An internal action is not deemed necessary at this time.The mandatory requirement to always check complaints history during a complaint investigation will ensure trends are constantly monitored.After considering this event the benefits of using this device still outweigh the known risks.

Event Description

Zfen-p-2-28-109 device was prepped and oriented as per instruction for use (ifu).The scallop and renal fenestrations were orientated as per the clock faces provided on the plan.Renal arteries were cannulated in 15 minutes and stented as per ifu.Trackability of wires, catheters and sheaths were smooth and no issues were present.Then, injector run was conducted as per ifu to assess the flow to vessels before moving onto the zfen-d-12-28-76 device and limbs.Superior mesenteric artery (sma) had normal flow as did the renal arteries.The case was continued with the bifurcated graft and 2x limbs as per ifu with nil issues.However, the final run showed minimal flow to sma and doctor queried the shuttering of the sma.It was decided that the sma should be stented.And it was challenging to get access to sma vessel.The 0¿18 wires and o¿35 cxi catheter were used to cross into the sma.Tracking the stent also proved challenging.But eventually, the stent was in place and deployed with nil issues.And the final run should flow to sma and renal¿s with nil issues.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane ; AS
• Manufacturer (Section G): COOK AUSTRALIA; brisbane technology park; 95 brandl street; eight mile plains, qld ; AS
• Manufacturer Contact: thejus baby ; brisbane technology park; 95 brandl street; eight mile plains, qld ; AS
• MDR Report Key: 19103090
• MDR Text Key: 340107894
• Report Number: 9680654-2024-00030
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002381565
• UDI-Public: (01)10827002381565(17)270311(10)AC1154876
• Combination Product (y/n): N
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZFEN-P-2-28-109
• Device Lot Number: AC1154876
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Sex: Male