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

Model Number	G35341
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	09/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter: successful case and outcome.Patient returned a week later with infected aorta.He was questioned to have infection before the case, but unconfirmed.Patient outcome: the patient is scheduled for an endograft explant of the device on the (b)(6) 2021.The patient had an enlarged aneurism, high white count.

• Brand Name: ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 12590574
• Report Number: 3005580113-2021-00115
• Device Sequence Number: 16966391
• Product Code: MIH
• UDI-Device Identifier: 10827002353418
• UDI-Public: (01)10827002353418(17)240621(10)E4125427
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/07/2021
• Report Date (Section F): 10/05/2021

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?: No
• Operator of Device: No Information
• Device Expiration Date: 06/21/2024
• Device Model Number: G35341
• Device Catalogue Number: ZTA-P-30-109-W
• Device Lot Number: E4125427
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/10/2021
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 69 YR