MAUDE Adverse Event Report: COOK MEDICAL LLC COOK Z-FEN AORTIC STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Renal Failure (2041); Fibrosis (3167); Unspecified Vascular Problem (4441)

Event Date 08/25/2022

Event Type  Injury  

Event Description

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: COOK Z-FEN AORTIC STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK MEDICAL LLC
• MDR Report Key: 16888435
• MDR Text Key: 314869348
• Report Number: MW5117363
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White