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

Catalog Number	ZFEN-P-2-28-94-R
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per rep - the patient was symptomatic.So, they took him for an angiogram.The angiogram revealed that the right renal artery was occluded.The physician said that the right renal artery stent appeared crushed.The crushed stent was a lifestream vascular covered stent manufactured by bard.There did not appear to be any problem with the cook components but the physician wanted the rep to report this to cook anyway.After the angiogram, the physician attempted to wire the stent and the renal artery.After three hours, he was unable to get into the renal artery.No further additional procedures have ben planned at this time.

• 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 ; AS
• MDR Report Key: 18312392
• Report Number: 3005580113-2023-00124
• Device Sequence Number: 20541204
• Product Code: MIH
• UDI-Device Identifier: 10827002325323
• UDI-Public: (01)10827002325323(17)260403(10)AC1131284
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/12/2023
• Report Date (Section F): 12/12/2023

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: 04/03/2026
• Device Catalogue Number: ZFEN-P-2-28-94-R
• Device Lot Number: AC1131284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/15/2023
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2023
• Date Device Manufactured: 04/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Date Report Sent to FDA: 12/12/2023