MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY

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
Common name: mih system, endovascular graft, aortic aneurysm treatment.Product code: mih.(b)(4).
Event or Problem Description
During cat scan the physician noted that the proximal / distal devices had separated causing and type iii endoleak.Patient is scheduled for an intervention on monday ((b)(6) 2019).Secondary intervention was performed on (b)(6) 2019 at c13984-1.The physician placed 2 additional grafts (zdeg-p-28-82-pf-us and a esbe-28-58-zt) inside the proximal and distal zfen grafts to bridge the gap and seal the devices.Final angiogram looked good and showed no evidence of endoleak.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY
• 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: 9563480
• Report Number: 3005580113-2020-00043
• Device Sequence Number: 16693673
• Product Code: MIH
• UDI-Device Identifier: 10827002325392
• UDI-Public: (01)10827002325392(17)191118(10)AC985418
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2020
• Report Date (Section F): 01/08/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2019
• Device Model Number: G32539
• Device Catalogue Number: ZFEN-P-2-32-109-R
• Device Lot Number: AC985418
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2020
• 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: 74 YR
• Date Report Sent to FDA: 01/08/2020