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

Catalog Number	G32551
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a graft implant procedure, a patient of undisclosed gender and age underwent an unspecified procedure in which the zenith fenestrated aaa endovascular graft distal bifurcation body, g32551 was used.It was reported the case went as normal.During the ending angiogram, the physician confirmed the graft looked good in place, the overlap was good.When the physician did a final run, the physician felt like there was a leak.The physician ballooned again and still felt there was a leak.Physician troubleshooted and felt the leak was with the graft itself.The graft remains implanted; the physician did not reintervene and will do a follow-up in thirty days.Further details of the procedure reveal the proximal graft was placed in accordance to ifu, ballooning of proximal graft with a 32 coda balloon, bilateral renal stenting with gore viabahn vbx stents, ballooning of renal stents with a mustang 10x2 balloon, placement of distal graft in accordance to ifu, placement of zsle 13 limb to extend and bridge zsle 24 in patient¿s left iliac, placement of zsle 20 in patient¿s right iliac, ballooning of proximal and distal body using a 32 coda balloon, ballooning of proximal overlap of zsles with distal body and iliacs using a 32 coda balloon, re-balloon of distal overlap and iliacs after angiogram revealed an endoleak.Of note is that the procedure was performed off label and gore viabahn vbx stents were used in the renals.An inflation device was used to deploy the renal stents and mustang 10x2 balloon to flare the vbxs in the renals.The device was implanted and remains in patient.The physician did not reintervene and will do a follow-up in thirty days.Physician noted may possibly need to do another bifurcation in replacement.

• 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 4113 ; AU 4113
• MDR Report Key: 23778960
• Report Number: 3005580113-2025-00074
• Device Sequence Number: 10105477
• Product Code: MIH
• UDI-Device Identifier: 10827002325514
• UDI-Public: (01)10827002325514(17)281017(10)AC1197501
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/01/2025
• Report Date (Section F): 12/11/2025

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 Catalogue Number: G32551
• Device Lot Number: AC1197501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/01/2025
• Date Report to Manufacturer: 12/03/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2025
• Date Device Manufactured: 10/17/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/11/2025