MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

Model Number	G35351
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Procode.Common name: mih system, endovascular graft, aortic aneurysm treatment.Product code: mih.
Event or Problem Description
Description of event according to initial reporter: "the zta-p-34-161-w was deployed in the descending thoracic aorta.There was evidence of a type 1b endoleak on the angiogram( 3005580113-2020-00057).The zta-p-34-113-w was then deployed distal to 1st device.The zta-p-38-117 was deployed proximal to the 1st device.Patient presented to the er at a neighboring hospital and was transferred for an emergent tbranch repair." it was further reported: "the fracture was discovered on (b)(6) 2019.At the final angiogram, a type ib endoleak was noted and a second stent graft was placed distal to the graft.A third stent was placed to get a better seal zone.Tbranch was noted for future treatment if necessary.The endoleak was discovered post angiogram on the initial implant on (b)(6) 2016.Additional stent was placed to resolve endoleak.".

• Brand Name: ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 9596706
• Report Number: 3005580113-2020-00070
• Device Sequence Number: 16937715
• Product Code: MIH
• UDI-Device Identifier: 10827002353517
• UDI-Public: (01)10827002353517(17)190524(10)E3452145
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/16/2020
• Report Date (Section F): 01/16/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/24/2019
• Device Model Number: G35351
• Device Catalogue Number: ZTA-P-34-161-W
• Device Lot Number: E3452145
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/08/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2020
• 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: 01/16/2020