MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G32500
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Final angio showed an endoleak distal to proximal & distal body overlap.Drs.Used a coda balloon to help seal proximal and distal body over lap (about 3.5 stent overlap) & then did another angio.The leak was still there.Drs.Inflated 32 coda balloon in overlap of the proximal & distal body and placed a pigtail marker just distal to the overlap (up the contra side - left iliac) and did an angio to see if there was still a leak.The endoleak was not coming from the proximal & distal body overlap, it looks like it is coming from a hole or tear in the distal pants, just proximal to the contra limb overlap.Drs.Placed an esbe to help seal endoleak.It looks like a small leak is still there.Drs.Plan to rescan patient in the next 30 days or so to see if the leak has sealed off.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED 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: 10288193
• Report Number: 3005580113-2020-00382
• Device Sequence Number: 3462411
• Product Code: MIH
• UDI-Device Identifier: 10827002325002
• UDI-Public: (01)10827002325002(17)230616(10)AC1060926
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2020
• Report Date (Section F): 07/16/2020

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: 06/16/2023
• Device Model Number: G32500
• Device Catalogue Number: ZFEN-D-12-28-106-C
• Device Lot Number: AC1060926
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/16/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/17/2020
• 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: Required Intervention
• Patient Age: 68 YR