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

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 330296586
• Report Number: 3005580113-2023-00124
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002325323
• UDI-Public: (01)10827002325323(17)260403(10)AC1131284
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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
• Date Report Sent to FDA: 12/12/2023
• Distributor Facility Aware Date: 11/15/2023
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2023
• Date Device Manufactured: 04/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male