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
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Zfen was placed (b)(6) 2020.Leak was thought to be potential type ll and we would re-evaluate.30 day ct follow up was performed and significant endoleak was still appreciated.Diagnostic angiograms confirmed type lll, thought to be tear of defect in flow divider.Patient was rescheduled to reline.
Event or Problem Description
Further information provided by the initial reporter states: other devices reportedly used during the procedure were "lunderquist wires, perclose, kumpe, bentson, marking pigtail catheter and coda balloon".The neck of the anatomy was reported to be "parallel, inverse funnel, funnel, narrowed, etc.Parallel, slightly irregular".No inflation device was reported to have been used.Ballooning was done on "top seal stents, junctions of main body and limbs, throughout limbs".Regarding any obstructions of high blood pressure with the graft during the endoleak, it was reported the "endoleak without any obstruction and later confirmed location with coda inflation in main body and then limbs".

• 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: 10787001
• Report Number: 3005580113-2020-00440
• Device Sequence Number: 2960116
• Product Code: MIH
• UDI-Device Identifier: 10827002325439
• UDI-Public: (01)10827002325439(17)230708(10)AC1062090
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020
• Report Date (Section F): 12/03/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2023
• Device Model Number: G32543
• Device Catalogue Number: ZFEN-P-2-30-124-R
• Device Lot Number: AC1062090
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/01/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 12/04/2020
• 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: Required Intervention
• Patient Age: 66 YR
• Date Report Sent to FDA: 12/03/2020