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-2-30-109

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Renal Failure (2041); Thrombosis (2100)

Event Type  Injury  

Event Description

Original implant was performed on the (b)(6) 2018 with a single fenestration.A 6x28 begraft stent was used.A downward facing renal artery was noted and it was difficult at the time to re-enter the stent to flare.Brachial cutdown was performed and then access from above was obtained to flare with an 8x20 angioplasty balloon.The patient recently presented for follow up and the stent was noted to be thrombosed.A loss of one renal artery was reported.

Event Description

Original implant was performed on (b)(6) 2018 with a single fenestration.A 6x28 begraft stent was used.A downward facing renal artery was noted and it was difficult at the time to re-enter the stent to flare.Brachial cutdown was performed and then access from above was obtained to flare with an 8x20 angioplasty balloon.The patient recently presented for follow up and the stent was noted to be thrombosed.A loss of one renal artery was reported.

Manufacturer Narrative

The device was not returned for evaluation.Three requests were made to acquire medical imaging but imaging was not provided for this case.Work order: (b)(4) was reviewed and appears complete and correct.The ifu lists renal complications and subsequent attendant problems (e.G., artery occlusion, contrast toxicity, insufficiency, failure) as a potential adverse event.The information suggests that the thrombosis occurred in the renal stent and not the fenestrated graft itself, so it is unlikely that any kind of graft non-conformance (e,g twisting, kinking, stent fracture) contributed to the complaint.It is possible that one or more of the following factors may have contributed to the complaint: graft is prone to thrombus formation, patient factors, procedural factors.

• 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 QLD 4 113; AS QLD 4113
• MDR Report Key: 10806373
• MDR Text Key: 215265336
• Report Number: 9680654-2020-00036
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002381596
• UDI-Public: (01)10827002381596(17)210730(10)AC1021494
• 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
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

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 Expiration Date: 07/30/2021
• Device Catalogue Number: ZFEN-P-2-30-109
• Device Lot Number: AC1021494
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/08/2020
• Supplement Dates Manufacturer Received: 10/27/2020
• Supplement Dates FDA Received: 01/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability