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	G32539
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient of undisclosed gender and age underwent an abdominal aortic aneurysm repair in (b)(6) 2018 in which a zenith fenestrated graft was implanted.The patient was lost to follow- up for quite some time, however, came back recently for a follow up.Per recent scan the physician detected a possible type 1a endoleak.The physician is planning a follow up procedure but not scheduled as of yet.For the follow up procedure the physician will be placing a non-cook manufactured stent.
Event or Problem Description
A patient of undisclosed gender and age underwent an abdominal aortic aneurysm repair in (b)(6)2018 in which a zenith fenestrated graft was implanted.The patient was lost to follow- up for quite some time, however, came back recently for a follow up.Per recent scan the physician detected a possible type 1a endoleak.The physician is planning a follow up procedure but not scheduled as of yet.For the follow up procedure the physician will be placing a non-cook manufactured stent.
Additional Manufacturer Narrative
No device was returned for evaluation as it remains implanted in the patient.Medical imaging was received to assist with the investigation.The imaging was reviewed by the medical director who noted that the device was initially implanted in (b)(6) 2018 and the patient was lost to follow up but returned for imaging on 15-nov-2022.The medical director commented the following on the ct imaging available: ¿the ct shows a large endoleak almost completely filling the aaa sac in front of the endograft.¿ the medical director further commented that it appears to be a type iii endoleak rather than initially reported type ia endoleak: ¿¿and arising mainly from the right renal fenestration, where the right renal bridging stent appears to have pulled out.There will be forward blood flow out through the open right renal fenestration, plus backflow from the right renal bridging stent.There is a lot of radio-opaque artifact on the ct scans in the vicinity of the right renal fenestration, which could be consistent with multiple coils that may have been deployed to try and stop the endoleak, although there is no mention of this in the report.¿ due to the mass of artifact the medical director noted it was impossible to accurately determine the site of the endoleak.It was stated the there was no visible evidence of flow getting outside proximally of the neck of the graft.The medical director commented that: ¿the most likely cause for this would be inadequate flaring of the right renal bridging stent, then gradual withdrawal of that stent from the fenestration of the intervening period.I think this is a failure due to a usage problem." additional information was received from the physician via the district manager.The physician thinks the endoleak was due to the right renal artery stent not extending into the aorta and it appeared that it could not have been flared much to further help with the seal.It was discussed that the endoleak would be treated by re-lining the right renal artery with a longer stent to extend further and flare more in the aorta, re-ballooning all junctures and potentially stent the superior mesenteric artery if warranted.The work order was reviewed for lot ac94549 and appears complete and the quality control inspection was verified to ensure the device passed inspection.There were no non-conformances raised or temporary deviations in place at the time of manufacture.It was concluded that the device was manufactured to specification.The instructions for use supplied with the device was reviewed and contains information that the long-term performance of fenestrated endovascular grafts, including the stents placed in fenestrations/scallops, have not yet been established.Patients are advices that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of their endovascular graft.It is listed that inaccurate placement and/or incomplete sealing of the device within the vessel may result in increased risk of endoleak, migration or inadvertent occlusion of the renal or internal iliac arteries.Based on the available information the investigation concluded that the most likely root cause is inadequate flaring of visceral stent.

• 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 ; AS
• Manufacturer (Section G): COOK AUSTRALIA; brisbane technology park; 95 brandl street; eight mile plains, qld 4113 ; AS 4113
• Manufacturer Contact: majbrit frosig ; brisbane technology park; 95 brandl street; eight mile plains, qld 4113 ; AS 4113 ; 738411188
• MDR Report Key: 16001996
• Report Number: 9680654-2022-00043
• Device Sequence Number: 20502948
• Product Code: MIH
• UDI-Device Identifier: 10827002325392
• UDI-Public: (01)10827002325392(17)180211(10)AC949549
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2023

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 Expiration Date: 02/11/2018
• Device Model Number: G32539
• Device Catalogue Number: ZFEN-P-2-32-109-R
• Device Lot Number: AC949549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2015
• 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 Sex: Unknown