MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G32562
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	04/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Awaiting imaging.
Event or Problem Description
Suspected fabric tear at crotch of graft: during original implant ((b)(6) 2025), an endoloeak was observed but the cause had not been confirmed.On (b)(6) 2025 - a follow up ct showed that the aneurysm grew 0.5 cm.On (b)(6) 2025 - an additional follow up ct showed that the aneurysm grew an additional 1.0 cm.On (b)(6) 2025 - the patient was taken in for an angiogram and bilateral limb component ballooning.It did not resolve the aneurysm.They did not do anything else.On (b)(6) 2026 - another ct showed an additional 0.5 cm of growth.On (b)(6) 2026 - the patient had an intervention that put in a gore excluder to resolve the issue.Additional information received: during the implant procedure, the device ifu was followed, and the device functioned as expected while following the ifu.Endoleak was discovred on the final angiogram during deployment procedure.There were no adverse events, but the patient was at risk for pending rupture.The patient outcome was successful re-intervention.No part of the procedure was performed off-label or out of the patient selection criteria.No difficulty was experienced during deployment.The patient's anatomy was a little tortuous, but not bad.The physician thinks a fabric tear on crotch caused the issue.The shape of the neck anatomy was angulated and reverse funnel.The graft was ballooned at all seal zones and overlap sites.Any pre or post implantation or adjunctive procedures? - extra ballooning.The graft was able to be deployed in the target zone.
Event or Problem Description
Suspected fabric tear at crotch of graft: during original implant ((b)(6) 2025), an endoloeak was observed but the cause had not been confirmed.(b)(6) 2025 - a follow up ct showed that the aneurysm grew 0.5 cm.(b)(6) 2025 - an additional follow up ct showed that the aneurysm grew an additional 1.0 cm.(b)(6) 2025 - the patient was taken in for an angiogram and bilateral limb component ballooning.It did not resolve the aneurysm.They did not do anything else.(b)(6) 2026 - another ct showed an additional 0.5 cm of growth.(b)(6) 2026 - the patient had an intervention that put in a gore excluder to resolve the issue.Additional information received: during the implant procedure, the device ifu was followed, and the device functioned as expected while following the ifu.Endoleak was discovred on the final angiogram during deployment procedure.There were no adverse events, but the patient was at risk for pending rupture.The patient outcome was successful re-intervention.No part of the procedure was performed off-label or out of the patient selection criteria.No difficulty was experienced during deployment.The patient's anatomy was a little tortuous, but not bad.The physician thinks a fabric tear on crotch caused the issue.The shape of the neck anatomy was angulated and reverse funnel.The graft was ballooned at all seal zones and overlap sites.Any pre or post implantation or adjunctive procedures? - extra ballooning.The graft was able to be deployed in the target zone.
Additional Manufacturer Narrative
The graft remains in situ and therefore was not returned for evaluation.However, images were provided and reviewed by clinical personnel and the following was determined: ¿there is an endoleak in the region of the bifurcation of the zfen-d device.However, the main accumulation of contrast in the endoleak is towards the right side of the bifurcation, with a small amount of contrast extending across in front of the bifurcation.I think it is most likely a type 3b endoleak from the crutch of the bifurcation and has just happened to spread slightly more to the right of the graft rather than between the limbs of the graft." review of the device history record for lot number ac1177876 found the work order appeared complete and the quality control inspection was verified to ensure that the device passed inspection.No non-conformances or temporary deviations were recorded at the time of manufacture.Review of specifications found that there are a number of controls and processes in place that wouldlikely identify faulty product prior to shipping.Review of the instructions for use (ifu) supplied with the device for general information found it to contain appropriate warnings, precautions, and instructions to the user, including: 4.Warnings and precautions.4.1 general use information.¿ 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.4.3 implant procedure: ¿ inaccurate placement and/or incomplete sealing of the zenith fenestrated aaa endovascular graft within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the renal or internal iliac arteries.Renal artery patency must be maintained to prevent/reduce the risk of renal failure and subsequent complications.It is recommended that all vessels accommodated by a small fenestration be stented in order to secure positive alignment of the graft fenestration with the vessel origin.5 adverse events lists: ¿ endoleak.¿ endoprosthesis: improper component placement; incomplete component deployment; component migration; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture; perigraft flow; barb separation and corrosion.There is no evidence to suggest that the user did not follow the instructions for use.A review of the manufacturing records and specifications did not reveal any discrepancies that could have contributed to the reported issue.The investigation concluded that the complaint device was manufactured to specification.Based on the medical director¿s assessment and information received, a definitive root cause could not be determined from the investigation.Possible causes are: - procedural related factors (e.G.Aggressive over ballooning).- patient related factors.- device related factors, such as mechanical stress or fatigue affecting the graft material.An internal action has been taken to address the issue.After considering this event the risk associated with the use of this device is still deemed adequate.Capa-00393 was initiated on 18-dec-2025 due to increase of complaints reporting tear/type iii endoleak at bifurcation in us zfen-d.The objective of this capa is to determine the underlying cause and implement corrective and preventive actions to avoid recurrence.This capa is currently in investigation.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT
• 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
• Manufacturer (Section G): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane 4113 ; AU 4113
• Manufacturer Contact: tia gibb ; 95 brandl street; eight mile plains; brisbane 4113 ; AU 4113
• MDR Report Key: 24310803
• Report Number: 9680654-2026-00032
• Device Sequence Number: 17555219
• Product Code: MIH
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P20018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: G32562
• Device Catalogue Number: ZFEN-D-16-45-76-C
• Device Lot Number: AC1177876
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: CAPA-00393
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male