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	G32543
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Zfen was placed (b)(6) 2020.Leak was thought to be potential type ll and we would re-evaluate.30 day ct follow up was performed and significant endoleak was still appreciated.Diagnostic angiograms confirmed type lll, thought to be tear of defect in flow divider.Patient was rescheduled to reline.
Additional Manufacturer Narrative
The device was not returned for evaluation.The william cook australia medical director reviewed the supplied imagining and confirmed there was an type iii endoleak and that it appears to be arising from a tear in the bifurcation of the distal component (zfen-d).It is not possible to speculate on the root cause of the tear from the imaging.Work order ac1062090 was reviewed and appears complete and correct.The ifu supplied with the complaint device for general information only lists endoleak as potential adverse events and states: ¿the long-term performance of endovascular grafts has not yet been established.All patients should be advised that endovascular treatment requires life long, regular follow-up to assess their health and performance of their endovascular graft¿.Based on the information provided a definitive root cause cannot be attributed, it is possible one of the following could have contributed to the reported issue: wear/abrasion/biodegradation at interface site between components procedural factors.
Event or Problem Description
Zfen was placed (b)(6) 2020.Leak was thought to be potential type ll and we would re-evaluate.30 day ct follow up was performed and significant endoleak was still appreciated.Diagnostic angiograms confirmed type lll, thought to be tear of defect in flow divider.Patient was rescheduled to reline.

• 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
• MDR Report Key: 10700421
• Report Number: 9680654-2020-00033
• Device Sequence Number: 11673858
• Product Code: MIH
• UDI-Device Identifier: 10827002325439
• UDI-Public: (01)10827002325439(17)230708(10)AC1062090
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2023
• Device Model Number: G32543
• Device Catalogue Number: ZFEN-P-2-30-124-R
• Device Lot Number: AC1062090
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 01/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR