MAUDE Adverse Event Report: COOK INC. COOK; ZENITH FLEX AAA ENDOVASCULAR GRAFT 18 FR

Model Number TFFB-22-82-2T

Device Problem Torn Material (3024)

Patient Problem No Information (3190)

Event Date 12/07/2017

Event Type  Injury  

Event Description

During an endovascular abdominal aortic aneurysm repair surgery, the main graft deployed had a tear defect in the graft was discovered after deployment.(cook tffb-22-82-2t, lot # 7567420).

• Brand Name: COOK
• Type of Device: ZENITH FLEX AAA ENDOVASCULAR GRAFT 18 FR
• Manufacturer (Section D): COOK INC. ; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7147587
• MDR Text Key: 95936281
• Report Number: MW5074238
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TFFB-22-82-2T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 69