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	G32542
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	12/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Originally stent was implanted on (b)(6) 2021.2 icast stents were also implanted both of 6x22, placed one on each side of renals respectively (left and right).Notice narrowing on (b)(6) 2021 of the superior mesenteric artery (sma) and the celiac artery with decreased flow.This required stenting of both arteries but information of stents used is unknown.Twisting may have contributed to the occurred event, but this cannot be determined.No twisting occurred during the original procedure.
Event or Problem Description
Originally stent was implanted on (b)(6) 2021.2 icast stents were also implanted both of 6x22, placed one on each side of renals respectively (left and right).Notice narrowing on (b)(6) 2021 of the superior mesenteric artery (sma) and the celiac artery with decreased flow.This required stenting of both arteries but information of stents used is unknown.Twisting may have contributed to the occurred event, but this cannot be determined.No twisting occurred during the original procedure.
Event or Problem Description
Originally stent was implanted on (b)(6) 2021.2 icast stents were also implanted both of 6x22, placed one on each side of renals respectively (left and right).Notice narrowing on (b)(6) 2021 of the superior mesenteric artery (sma) and the celiac artery with decreased flow.This required stenting of both arteries but information of stents used is unknown.Twisting may have contributed to the occurred event, but this cannot be determined.No twisting occurred during the original procedure.
Additional Manufacturer Narrative
No part of the device was returned for investigation.No images were supplied.The relevant manufacturing records were reviewed and appeared complete and correct.A review of specifications found that there are a number of processes and checks in place which would likely identify a device deficiency prior to shipment.The instructions for use (ifu) supplied with the device states: "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.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) as potential adverse events.Based on the information received a definitive root cause could not be determined.It is possible that one or more of the following factors contributed to the event: -kinking/ collapse/excessive prolapse of implant/folding of implant material between stents -patient related factors.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY
• Common Device Name: 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
• Manufacturer (Section G): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane QLD 4 113; AS QLD 4113
• Manufacturer Contact: meena harish ; 95 brandl street; eight mile plains; brisbane QLD 4-113 ; AS QLD 4113
• MDR Report Key: 13064725
• Report Number: 9680654-2021-00022
• Device Sequence Number: 12169816
• Product Code: MIH
• UDI-Device Identifier: 10827002325422
• UDI-Public: (01)10827002325422(17)231116(10)AC1069091
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/16/2023
• Device Model Number: G32542
• Device Catalogue Number: ZFEN-P-2-28-124-R
• Device Lot Number: AC1069091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female