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

Model Number G32548

Device Problem Improper Flow or Infusion (2954)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 04/21/2020

Event Type  Injury  

Event Description

Zfen was involved in procedure, but physician believes icast was allegedly the problem device (limited blood flow into the patient's right renal).It was further reported: an icast was used on rt renal.5x22x120.Other devices used during the procedure: cook distal body 12-28-76 , zsle rt iliac, zsle left iliac and icast in left renal 6x22x120.This was a fenestrated case.

Event Description

Zfen was involved in procedure, but physician believes icast was allegedly the problem device (limited blood flow into the patient's right renal).It was further reported: an icast was used on rt renal.5x22x120 other devices used during the procedure: cook distal body 12-28-76 , zsle rt iliac, zsle left iliac and icast in left renal 6x22x120.This was a fenestrated case.

Manufacturer Narrative

The device was not returned for evaluation.Imagery and planning/sizing information was requested; however, none were received.Work order ac1045694 was reviewed and appears complete and correct.The ifu sent with the complaint device states that "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.It is recommended that all vessels accommodated by a small fenestration be stented in order to secure positive alignment of the graft fenestration with the vessel origin." and lists "organ impairment/loss due to side-branch vessel occlusion (in particular, renal and/or gastrointestinal impairment/loss)" and "renal complications and subsequent attendant problems (e.G., artery stenosis or occlusion, contrast toxicity, infarct, insufficiency, failure)" as potential adverse events.Based on the information received it is difficult to determine an exact root cause.It is possible that one or more of the following factors contributed to the complaint: -twisting of the implant within the delivery system -kinking/ collapse/excessive prolapse of implant/folding of implant material between stents -insufficient expansion of the peripheral stent.

• 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: 10023211
• MDR Text Key: 193294981
• Report Number: 9680654-2020-00018
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002325484
• UDI-Public: (01)10827002325484(17)220930(10)AC1045694
• 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: 06/16/2020

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: 09/30/2022
• Device Model Number: G32548
• Device Catalogue Number: ZFEN-P-2-36-122-R
• Device Lot Number: AC1045694
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/22/2020
• Initial Date FDA Received: 05/05/2020
• Supplement Dates Manufacturer Received: 04/22/2020
• Supplement Dates FDA Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR