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	G32543
Medical Device Problem Codes	Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Standard access was used for zfen procedure.20fr x 25 cook sheath was placed in patien't right groin along with a marking catheter, 7fr steerable sheath, and 6fr hf ansel sheath (straight).The physician cannulated the right renal and inflated a 3mm angioplasty balloon to treat stenosis.A 20fr dilator was placed in the left groin.Cook fenestrated device was flushed and prepped on the back table.An aortagram was completed using the 5fr marking catheter.The dilator in the left groin was removed and the custom made fenestrated device was placed into the patient's abdominal aorta.Orientation was checked by rep and surgeon and then deployment began.The device had great orientation using the cross-hair markers on the graft.Proximal distal location was corrected as the device was slowly deployed completely.The physician then cannulated the distal body with a wire/catheter and confirmed he was inside the graft.They began to attempt to cannulate the right renal first.They were able to get the sheath/catheter/wire combination through the fenestration but had no luck actually cannulating the right renal.Multiple attempts were made with no success.They then switch to attempt at cannulate the left renal artery.No success again from the left side.They took multiple images and runs to try and view the renal arteries but were never able to see them again.Multiple attempts to cannulate both sides took place without success.Additional information received: was the device positioned on the patient¿s abdomen prior to insertion to confirm that the graft was in the correct orientation? yes, the device was oriented correctly on the patient¿s abdomen.Was there any evidence of a twisted graft prior insertion? if yes, was the graft twisted from the proximal end to the distal end? or did the entire graft rotate? no, the graft was not twisted, it passed smoothly and accurately without too much manipulation.The graft was able to turn and be manipulated without much difficulty.Was intraoperative imaging sufficient to guide precise stent deployment? yes, proper imaging was used and appeared accurate.Was the stent graft properly aligned before full deployment? it may have deployed slightly high but the cross-hares on the zfen proximal body were dead on accurate.Was there any migration or unintended movement of the stent graft during deployment? no migration was present but, it may have deployed 2-4mm high in the patient.Actions were taken to bring the device down to what was thought was the appropriate location.Was there significant vessel tortuosity that contributed to misalignment? tortuosity was not a major concern for this patient.Was there vessel spasm or stenosis that prevented easy cannulation? stenosis in the aorta just below the renal arteries was the main area of concern that they were fighting against.Did the patient have anatomic variants that made alignment more difficult? yes, severe stenosis below the renal arteries and even through the visceral area was a major challenge known prior to building the graft and during the procedure.What was the patient outcome? patient was converted to an open procedure and the zfen graft was explanted from the patient.
Additional Manufacturer Narrative
The graft was not returned for evaluation.However, images were provided and reviewed by the medical director, who stated ¿i can confirm that there is a very short segment, quite narrow stenosis immediately below the renal arteries, which would indeed have made cannulation of the renals very tricky.It seems that this was a problem related to a tight stenosis of the aorta just below the renal arteries, making alignment and ¿steerability¿ of the cannulation wires and catheters very difficult, and resulted in inability to cannulate either of the renal arteries.This, of course, would have put serious time pressure on the procedure, as both renal arteries were covered and not perfused, so they made the decision to convert to open repair, with an apparent good outcome.It seems that the problem was with the patient¿s anatomy (the tight stenosis of the aorta) and not any fault or failure of the endovascular device or delivery system¿.Review of the device history record for lot number ac1176824 found the work order appeared complete and the quality control inspection record was verified to ensure that the device passed inspection.There were no non-conformances or related temporary deviations in place at the time of manufacturing.Upon reviewing the photos taken of the complaint device during manufacture, it appears that the device was manufactured to specification.Review of specifications found that there are a number of controls and processes in place that would 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: 4.3 implant procedure - fluoroscopy should be used during introduction and deployment to confirm proper operation of the delivery system components, proper placement of the graft, and desired procedural outcome.- 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 potential adverse events that may occur and/or require intervention include, but are not limited to: ¿ 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 ¿ occlusion of device or native vessel ¿ organ impairment/loss due to side-branch vessel occlusion (in particular, renal and/or gastrointestinal impairment/loss) ¿ surgical conversion to open repair 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 investigation and review of supplied imaging, the root cause was identified as being due to the patient¿s anatomy (the tight stenosis of the aorta) contributing to the difficulty experienced cannulating either renal artery.After considering this event the risk associated with the use of this device is still deemed adequate.The appropriate personnel will continue to monitor for similar complaints.An internal action is not deemed necessary at this time.Trending will monitor if any future actions are required.

• 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 4113 ; AU 4113
• Manufacturer (Section G): WILLIAM A. COOK AUSTRALIA PTY LTD; 95 brandl street; eight mile plains; brisbane, qld 4113 ; AU 4113
• Manufacturer Contact: tia gibb ; 95 brandl street; eight mile plains; brisbane, qld 4113 ; AU 4113
• MDR Report Key: 21782790
• Report Number: 9680654-2025-00008
• Device Sequence Number: 8427580
• Product Code: MIH
• UDI-Device Identifier: 10827002325439
• UDI-Public: (01)10827002325439(17)280122(10)AC1176824
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2025

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 Model Number: G32543
• Device Catalogue Number: ZFEN-P-2-30-124-R
• Device Lot Number: AC1176824
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female