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

Model Number	G32554
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	04/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Both components were placed, then there was a persistent leak at the distal end, that would not stop.They tried to re-balloon but this did not resolve the issue.They resolved the issue by relining the fenestrated graft using a 28mm gore graft instead.(gore graft placement was an additional procedure, and they placed two additional limbs with the graft as well.) the plan for follow up is to do a cta.
Event or Problem Description
Both components were placed, then there was a persistent leak at the distal end, that would not stop.They tried to re-balloon but this did not resolve the issue.They resolved the issue by relining the fenestrated graft using a 28mm gore graft instead.(gore graft placement was an additional procedure, and they placed two additional limbs with the graft as well.) the plan for follow up is to do a cta.
Event or Problem Description
Both components were placed, then there was a persistent leak at the distal end, that would not stop.They tried to re-balloon but this did not resolve the issue.They resolved the issue by relining the fenestrated graft using a 28mm gore graft instead.(gore graft placement was an additional procedure, and they placed two additional limbs with the graft as well.) the plan for follow up is to do a cta.
Additional Manufacturer Narrative
Additional information received: could you provide a more detailed description of the event? there was a jetting of contrast by the flow divider on final angio.Clarify the exact location of the persistent leak? appeared to be around the flow divider of the distal component.What does the physician think caused the leak? she believes the graft material on the distal component was compromised in some way.How was the leak discovered and during which step in the ifu was the nonconformance first identified? during final angiogram after all components were placed.(proximal/distal fenestration components and both iliac limbs).Was a patient's anatomy tortuous? no.Within normal range.Please provide the type and size of the balloon used to expand the zfen-d graft.The physician used a mob balloon for all the molding of both graft components & iliac limbs.What was the ballooning technique used (i.E., kissing balloon technique or ballooning each leg separately)? molding of both the proximal & distal components and iliac limbs.Kissing balloons (12mm) were done in iliac limbs to try and resolve the leak.How is the patient doing now? fine as far as i know.Patient was discharged next day.What was the date of the secondary intervention (described in the description of event as 'graft placement was an additional procedure, and they placed two additional limbs')? graft relining with gore excluder and limbs occurred the same day while patient was still in the or.The investigation is ongoing.
Additional Manufacturer Narrative
The graft remains in situ and therefore was not returned for evaluation.Images were requested on three occasions; however, they could not be provided.Review of the device history record for lot number ac1188720 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 the instructions for use (ifu) supplied with the device for information only 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 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 information received, a definitive root cause could not be determined from the investigation.Possible causes are: procedural related factors (e.G.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 due to increase of complaints reporting tear/type iii endoleak at bifurcation of the graft.The objective of the capa is to determine the underlying cause and implement corrective and preventive actions to avoid recurrence.The capa is currently in 'pending implementation'.The appropriate personnel will continue to monitor for similar complaints.

• 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 ; AU
• 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: 24991104
• Report Number: 9680654-2026-00064
• Device Sequence Number: 18725280
• Product Code: MIH
• UDI-Device Identifier: 10827002325545
• UDI-Public: (01)10827002325545(17)280701(10)AC1188720
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P20018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2026

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: G32554
• Device Catalogue Number: ZFEN-D-12-28-91-C
• Device Lot Number: AC1188720
• 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): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/13/2026; 04/13/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 05/19/2026; 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2025
• 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: 77 YR
• Patient Sex: Male