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	G32546
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Following the procedure for implantation, there was a leak at the distal edge of the overlap between the two devices on completion angiogram.The source of the leak could not be determined.The physician implanted two additional covered stents extending slightly above the flow divider and post dilated them.Another angiogram following this showed the leak to be repaired but the exact source of the leak was not identified.
Event or Problem Description
Following the procedure for implantation, there was a leak at the distal edge of the overlap between the two devices on completion angiogram.The source of the leak could not be determined.The physician implanted two additional covered stents extending slightly above the flow divider and post dilated them.Another angiogram following this showed the leak to be repaired but the exact source of the leak was not identified.
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."there is a type 3 endoleak that appears to be emerging from the distal end of the overlap between the proximal and distal main body components (zfen-p and zfen-d)." work order ac1036278 was reviewed and appears complete and correct.Upon reviewing the photos taken of the complaint device during manufacture it appears that the device was manufactured as per the form signed by the physician.The device ifu states: "potential adverse events that may occur and/or require intervention include, but are not limited to: endoleak." "the long-term performance of fenestrated endovascular grafts, including the stents placed in fenestrations/scallops, has not yet been established.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.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms, changes in the structure or position of the endovascular graft, or stenosis/occlusion of vessels accommodated by fenestrations) should receive enhanced follow-up." based on the information received it is difficult to determine an exact root cause.The following factors may have contributed: - anatomical characteristics at seal site not suitable for endovascular repair - inadequate sizing of implant - insufficient ballooning of the overlap region.

• 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: 9079571
• Report Number: 9680654-2019-00032
• Device Sequence Number: 14095277
• Product Code: MIH
• UDI-Device Identifier: 10827002325460
• UDI-Public: (01)10827002325460(17)220426(10)AC1036278
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 11/25/2019

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: 04/26/2022
• Device Model Number: G32546
• Device Catalogue Number: ZFEN-P-2-36-107-R
• Device Lot Number: AC1036278
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 11/24/2019
• 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: 64 YR
• Patient Weight: 177