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-R

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2024

Event Type  malfunction  

Event Description

A patient of undisclosed gender and age underwent a zfen procedure on (b)(6) 2024 in which the zenith fenestrated aaa endovascular graft proximal body, g32537, was implanted."the proximal body zfen graft was twisted within the sheath.The rra (right renal artery) was a 10mm scallop that was supposed to be at 9:30 and under fluoro/inside the sheath the scallop was at about 1:00.The lra was in what looked to be the correct location (29mm from pe) as well as the anterior posterior marks.Once we started to unsheathe the rra fen started to move towards the patients right some, we had to do some wiggling of the graft to get it closer to the correct position.Once the graft was fully deployed the fen was closer to 10:15 to 10:30 as opposed to 9:30 making cannulation of the renal very difficult.I do not have pictures." additional information received: the physician think the device being incorrectly loaded in the sheath caused the issue the device was inspected prior to use in order to ensure no damage has occurred; no damage had occurred to packaging to device the device was positioned on the patient¿s abdomen prior to insertion to confirm that the graft was in the correct orientation, that was when the discrepancy was discovered.The anterior/posterior markers formed a cross and the tick marker appeared to be in the correct orientation.The anterior markers aligned with the tick mark when the gold markers were checked under fluoroscopy prior to insertion into the patient.The thumb screws (rmts) were aligned at 12 o¿clock, and were aligned with the anterior gold markers.The trigger wire was released per the ifu.The gold markers on the graft were not aligned as per the ifu; the rra was a scallop, was supposed to be at 9:30 and within the sheath it was at about 1:00, once deployed it was at about 10:30.All other markers appeared correct the gold markers did not rotate as per the ifu pre-procedure, the anterior markers were loaded near the inner cannula of the sheath so they did not rotate as expected it was not possible to align all the branches, fenestrations and scallops with the native vessels - not the rra deployment and branch, fenestrations and scallops alignment were done per the ifu the physician was able to land in the correct location but the rra was still misaligned.She had to wiggle the graft in the patient and do some corrective rotation to try to get it to line up the patient anatomy was not tortuous there was difficulty positioning graft there was difficulty accessing fenestrations/scallops/branches - the rra fen, we were unable to canulate before releasing the device from the delivery system no difficulty withdrawing trigger wires no difficulty deploying top cap the delivery system was rotated together as per the ifu no difficulties with the top cap removal or docking of the top cap for withdrawal no resistance on withdrawal of the device no point were the delivery system became twisted? (tortuous anatomy).The device was inspected prior to use in order to ensure no damage has occurred the device was able to be advanced to the target site the anterior markers realign into the correct orientation without adjustment by the physician after the top cap was deployed - but rra scallop did not the fenestrations were not correctly lined up in the sheath before and after deployment of the proximal body.We had to rotate the graft some after it was fully unsheathed to help correct for the right renal misalignment.We also were unable to cannulate the rra scallop while the graft was constrained.We ended up having to fully deploy the graft and try to get in after it was fully deployed but this was very difficult.The anterior markers realigned into the correct orientation without adjustment by the physician after the top cap was deployed, but rra scallop did not.(the rra scallop fenestration was originally at about 1:00 instead of 9:30.All other fenestrations and anterior posterior markers looked correct.As we started to unsheathe the device it started to somewhat self correct and the right renal fenestration started falling towards the patients right.But even once fully unsheathed and with some wiggling the fenestration was still at about 10:30 instead of 9:30.).

• 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): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane ; AS
• Manufacturer Contact: tia gibb ; 95 brandl street; eight mile plains; brisbane ; AS
• MDR Report Key: 18966645
• MDR Text Key: 338691765
• Report Number: 9680654-2024-00021
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002325378
• UDI-Public: (01)10827002325378(17)270205(10)AC1152130
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZFEN-P-2-28-109-R
• Device Lot Number: AC1152130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2024
• 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