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	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
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.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: 11029151
• Report Number: 3005580113-2020-00461
• Device Sequence Number: 667809
• 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
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2020
• Report Date (Section F): 12/08/2020

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/18/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2020
• 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