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	G32550
Health Effect - Clinical Code	Death (1802)
Date of Event	12/19/2019
Type of Reportable Event	Death
Event or Problem Description
As initially reported to customer relations via emailed complaint form from district manager: an (b)(6) year old male patient underwent an fevar on the aorta on (b)(6) 2019 in which a zenith fenestrated aaa endovascular graft proximal body, g32550, and a zenith fenestrated aaa endovascular graft distal bifurcated body, g32500, and two 6x22mm atrium icast stents were implanted on (b)(6) 2019.After (b)(6) 2019 the abdominal aneurysm continued to grow around the fenestrated implant.There was separation of the icast renal stent from the proximal fenestrated graft.On (b)(6) 2019 the patient presented w/ aortic rupture including separation of the right renal stent (6x22 icast) from the proximal fenestrated graft.Additional implants, three gore viabahn stents were used as well as a cook zdeg-p-38-79-pf-us & a esbe-36-50-zt & zta-p-40-117-w, were added to stop the hemorrhage but did not fix the ruptured aorta.Patient expired on (b)(6) 2019.

• 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: 9588509
• Report Number: 3005580113-2020-00058
• Device Sequence Number: 2423343
• Product Code: MIH
• UDI-Device Identifier: 10827002325507
• UDI-Public: (01)10827002325507(17)220923(10)AC1045302
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/14/2020
• Report Date (Section F): 01/14/2020

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: 09/23/2022
• Device Model Number: G32550
• Device Catalogue Number: ZFEN-P-2-36-137-R
• Device Lot Number: AC1045302
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/27/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2020
• 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: Death
• Patient Age: 84 YR
• Date Report Sent to FDA: 01/14/2020