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 G32561

Device Problem Material Separation (1562)

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

Event Date 08/30/2021

Event Type  Injury  

Event Description

The patient was discovered unconscious at home by a family member and was brought to the hospital where an imaging procedure was performed.Imaging showed that the aneurysm sac appeared to be enlarged and component separation.The patient has refused further treatment.

• 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: 12545860
• MDR Text Key: 273751554
• Report Number: 3005580113-2021-00111
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002325613
• UDI-Public: (01)10827002325613(17)220306(10)AC1033237
• 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: 09/29/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2022
• Device Model Number: G32561
• Device Catalogue Number: ZFEN-D-12-45-76-C
• Device Lot Number: AC1033237
• 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: 09/29/2021
• Distributor Facility Aware Date: 09/01/2021
• Device Age: 30 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2021
• Date Device Manufactured: 03/06/2019
• 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): Life Threatening
• Patient Age: 95 YR