MAUDE Adverse Event Report: William A. Cook Australia, PTY LTD Zenith Branch Endovascular Graft Iliac Bifurcation; MIH System, Endovascular Graft, Aortic Aneurysm Treatment

Model Number	G60345
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	07/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The implant procedure was an iliac branch with a zbis on the left, with competitor grafts for everything else: evar hypo stent with vbx, gore limbs to bridge.They sealed into the top of the zbis with the 14.5 ispi leg of the exculder.Brisk endoleak was visible at level of the zbis flow divider.They then relined the vbx thinking maybe it was a type c and occuleded above the flow divider with a coda.The leak was still there.They then relined the ipsi limb with another limb.Leak was still there.Reballooned and took different angles to rule out type 2 or any other leak elsewhere.Doctor seems confident now after reflection it could only be coming from the zbis at the area of the flow divider somehow.(the physician called the cook representative to complain that she is fairly certain now that this is type 4 endoleak of some kind due to the graft.).
Additional Manufacturer Narrative
Investigation is in progress.Blank fields on this form indicate the information is unknown or unavailable.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: Zenith Branch Endovascular Graft Iliac Bifurcation
• 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 ; AS 4113
• Manufacturer (Section G): William A. Cook Australia, PTY LTD; 95 brandl street; eight mile plains; brisbane 4113 ; AS 4113
• Manufacturer Contact: tia gibb ; 95 brandl street; eight mile plains; brisbane 4113 ; AS 4113 ; NI
• MDR Report Key: 50423841
• Report Number: 9680654-2026-00103
• Device Sequence Number: 21438621
• Product Code: MIH
• UDI-Device Identifier: 10827002603452
• UDI-Public: 10827002603452
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 08/24/2026

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 Model Number: G60345
• Device Catalogue Number: ZBIS-12-61-41-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male