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

Patient Problem Ruptured Aneurysm (4436)

Event Date 03/26/2024

Event Type  Death  

Event Description

Per the vascular surgeon's op note: infrarenal abdominal aortic aneurysm rupture, in the setting of prior cook z-fen endograft repair in 2019 at outside hospital.Intraoperative findings were consistent with a type iii endoleak-endograft component separation - likely causing the sac expansion and eventual rupture.The pt expired on (b)(6) 2024.

• Brand Name: COOK Z-FEN ENDOGRAFT STENT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): COOK MEDICAL LLC.
• MDR Report Key: 19013612
• MDR Text Key: 339119352
• Report Number: MW5153430
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 03/29/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White