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

Model Number	G32551
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
During a post op scan, an endoleak was noted around the aortic bifurcation and it was associated with abdominal aortic aneurysm growth.The patient was brought in for a diagnostic angiogram and additional cta.Type two and three leaks were ruled out and it was concluded that there was a type four leak at the bifurcation of the distal graft.The surgeon decided to reline the distal graft with a flex device and new limbs.He does not want a credit on any items, is not explanting anything and is happy with the final result, but wants it noted that he believes the bifurcated zfen graft had a porosity issue.
Event or Problem Description
During a post op scan, an endoleak was noted around the aortic bifurcation and it was associated with abdominal aortic aneurysm growth.The patient was brought in for a diagnostic angiogram and additional cta.Type two and three leaks were ruled out and it was concluded that there was a type four leak at the bifurcation of the distal graft.The surgeon decided to reline the distal graft with a flex device and new limbs.He does not want a credit on any items, is not explanting anything and is happy with the final result, but wants it noted that he believes the bifurcated zfen graft had a porosity issue.
Additional Manufacturer Narrative
The grafts remains in situ, and therefore was not returned for evaluation.Images were provided and reviewed by medical director at william cook australia.The medical director stated that the endoleak does indeed appear to be from the distal graft component, and more specifically from around the bifurcation.Based on the imaging provided, it appears that it may be coming from a more localized area than just general fabric porosity.It may be coming from a small tear in the fabric of the left limb of the graft.Work order ac1050083 was reviewed and appears complete and correct.There are a number of processes and checks in place to ensure that any holes or damage to the graft is identified during manufacture.The device ifu states: "potential adverse events that may occur and/or require intervention include, but are not limited to: endoleak" based on the information received, it appears that the endoleak may be coming from a small tear in the fabric of the left limb of the graft.It is possible that one or more of the following factors contributed to the complaint: wear/abrasion/biodegradation at interface site between components; inadequate material selection; procedural factors.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED 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: 10085930
• Report Number: 9680654-2020-00021
• Device Sequence Number: 2561183
• Product Code: MIH
• UDI-Device Identifier: 10827002325514
• UDI-Public: (01)10827002325514(17)221127(10)AC1050083
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/27/2022
• Device Model Number: G32551
• Device Catalogue Number: ZFEN-D-12-28-76-C
• Device Lot Number: AC1050083
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2020
• Supplement Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 07/05/2020
• 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: 65 YR