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	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported via (b)(6) by the physician "2nd image it's from 2019.Please note renal stents facing each other.Last image done recently shows renal stent facing downward due to migration.First image, catheter through the large superior mesenteric artery (sma) fen with contrast filling the sac.The fenestrated endovascular aortic repair (fevar) was done 2019 locally, sent to me for type 2 endoleak.Angio reveals type 1a.Large sma fen partially covering sma due to stent migration.(b)(6) year old male but with severe mr and pulm htn.".
Additional Manufacturer Narrative
The device was not returned for evaluation.A request was made for the imaging, however the clinical programs manager noted there was only pre-op planning imaging available.Work order ac1048552 was reviewed and appears complete and correct.The device ifu states: - "endoleak" is listed as a potential adverse event.- "patients with specific clinical findings (e.G.,endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive additional follow-up" - "the long-term performance of endovascular grafts has not yet been established.All patients should be advised that endovascular treatment requires life long, regular follow-up to assess their health and performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive additional follow-up" the type ia endoleak appears to be related to the migration of the device, however the root cause of the migration is unknow.
Event or Problem Description
As reported via twitter by the physician "2nd image it's from 2019.Please note renal stents facing each other.Last image done recently shows renal stent facing downward due to migration.First image, catheter through the large superior mesenteric artery (sma) fen with contrast filling the sac.The fenestrated endovascular aortic repair (fevar) was done 2019 locally, sent to me for type 2 endoleak.Angio reveals type 1a.Large sma fen partially covering sma due to stent migration.60 year old male but with severe mr and pulm htn.".

• 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 QLD 4 113; AS QLD 4113
• MDR Report Key: 10955709
• Report Number: 9680654-2020-00039
• Device Sequence Number: 2419805
• Product Code: MIH
• UDI-Device Identifier: 10827002325392
• UDI-Public: (01)10827002325392(17)221106(10)AC1048552
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 02/15/2021

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: 11/06/2022
• Device Model Number: G32539
• Device Catalogue Number: ZFEN-P-2-32-109-R
• Device Lot Number: AC1048552
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 12/06/2020
• Supplement Report FDA Received Date: 02/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 60 YR