MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number G32551

Device Problem Material Separation (1562)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Approximately three years post implant, the bifurcated graft separated from the tube graft.The physician had to reline the endograft.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED 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 QLD 4 113; AS QLD 4113
• MDR Report Key: 14187042
• MDR Text Key: 289875345
• Report Number: 3005580113-2022-00049
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002325514
• UDI-Public: (01)10827002325514(17)200808(10)AC1001202
• 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: 04/22/2022

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 Expiration Date: 08/08/2020
• Device Model Number: G32551
• Device Catalogue Number: ZFEN-D-12-28-76-C
• Device Lot Number: AC1001202
• 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: 04/22/2022
• Distributor Facility Aware Date: 04/01/2022
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/22/2022
• Date Device Manufactured: 08/08/2017
• 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: 65 YR
• Patient Sex: Male