MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number G35337

Device Problem Packaging Problem (3007)

Patient Problem Unspecified Infection (1930)

Event Type  Death  

Event Description

Description of event according to initial reporter: email 28apr2022: the physician deployed the device in the thoracic aorta just distal to the left subclavian artery.The device deployed normally and had no technical issues.The graft landed slightly distal to where they wanted to land but were happy with the result after angiogram.Patient came back to hospital a week after release and passed away from infection.Aorta and graft were infected.She is unsure as to why this happened and what caused infection.Patient outcome: patient passed away.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 14495506
• MDR Text Key: 292586938
• Report Number: 3005580113-2022-00062
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002353371
• UDI-Public: (01)10827002353371(17)240319(10)E4087410
• 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: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2024
• Device Model Number: G35337
• Device Catalogue Number: ZTA-P-28-109-W
• Device Lot Number: E4087410
• 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: 05/25/2022
• Distributor Facility Aware Date: 04/26/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/23/2022
• Date Device Manufactured: 03/19/2021
• 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): Death
• Patient Sex: Male