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
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Event or Problem Description
At the end of the procedure the physician looked at the graft and noted a leak and placed a cuff graft which worked.At the one month follow up a type iii endoleak was noted at what appears to be the crotch area of the graft.The physician will schedule a repair procedure.
Additional Manufacturer Narrative
The device was not returned for evaluation.Work order (b)(4) 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 william cook australia medical director reviewed the supplied imagining and confirmed there was an endoleak, this endoleak is seen to be emerging between the distal end of the zfen-p and the bifurcated portion of the zfen-d.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.There is no evidence to indicate that the device was not manufactured to specification.
Event or Problem Description
At the end of the procedure the physician looked at the graft and noted a leak and placed a cuff graft which worked.At the one month follow up a type iii endoleak was noted at what appears to be the crotch area of the graft.The physician will schedule a repair procedure.

• 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: 10977525
• Report Number: 9680654-2020-00040
• Device Sequence Number: 4282401
• Product Code: MIH
• UDI-Device Identifier: 10827002325514
• UDI-Public: (01)10827002325514(17)230915(10)AC1065656
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/01/2021

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: 09/15/2023
• Device Model Number: G32551
• Device Catalogue Number: ZFEN-D-12-28-76-C
• Device Lot Number: AC1065656
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 01/31/2021
• 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