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 Codes	Device Slipped (1584); Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The proximal and distal pieces have separated, creating an endoleak.The physician placed a bridging piece (an alpha thoracic piece) to bridge the separation successfully.
Additional Manufacturer Narrative
The device was not returned for evaluation.The william cook australia medical director reviewed the supplied imagining and confirmed the separation between the zfen-p and zfen-d being the cause of the endoleak.Work order ac1008611 was reviewed and appears complete and correct.The ifu states that the long-term performance of fenestrated endovascular grafts, including the stents placed in fenestrations/scallops, has not yet been established, and all patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of their endovascular graft.Potential adverse events that may occur and/or require intervention include, but are not limited to: endoleak, component migration.Based on the information provided, the root cause of the difficulty reported by the healthcare facility is unknown.
Event or Problem Description
The proximal and distal pieces have separated, creating an endoleak.The physician placed a bridging piece (an alpha thoracic piece) to bridge the separation successfully.

• 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: 11013719
• Report Number: 9680654-2020-00042
• Device Sequence Number: 869623
• Product Code: MIH
• UDI-Device Identifier: 10827002325439
• UDI-Public: (01)10827002325439(17)201213(10)AC1008611
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2021

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: 12/13/2020
• Device Model Number: G32543
• Device Catalogue Number: ZFEN-P-2-30-124-R
• Device Lot Number: AC1008611
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 02/07/2021
• 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: 83 YR