MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED GRAFT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number UNKNOWN

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Renal Failure (2041)

Event Date 08/25/2022

Event Type  Injury  

Event Description

Per medwatch form: retroperitoneal fibrosis s/p (status post) fenestrated endograft repair two years previously.Retroperitoneal fibrosis involves the ureters causing renal failure and requiring ureteral stenting.Extensive thickening of aortoiliac vessels in area of aneurysmal disease.

• Brand Name: ZENITH FENESTRATED GRAFT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane ; AS
• MDR Report Key: 17022424
• MDR Text Key: 316153525
• Report Number: 3005580113-2023-00068
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• 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: 05/30/2023
• Distributor Facility Aware Date: 05/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/25/2023
• 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): Disability