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

Model Number	G38220
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the initial reporter: "the thoracic graft was placed and appears to be enfolding at the proximal seal stent." patient outcome is unknown at this time.
Event or Problem Description
It was reported that the patient was supposed to return for another aortic intervention and possible attempt to repair the infolding.The patient is saying the pain is gone and not returning for follow up.Appeared that the bare stent released just prior to the pro form suture and the graft tipped towards the lesser curve of the arch.

• Brand Name: ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED 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: 9631357
• Report Number: 3005580113-2020-00112
• Device Sequence Number: 16811322
• Product Code: MIH
• UDI-Device Identifier: 10827002382203
• UDI-Public: (01)10827002382203(17)200403(10)E3569142
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2020
• Report Date (Section F): 02/28/2020

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: 04/03/2020
• Device Model Number: G38220
• Device Catalogue Number: ZTA-PT-46-42-179-W
• Device Lot Number: E3569142
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/14/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 02/28/2020
• 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
• Date Report Sent to FDA: 02/28/2020