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

Model Number	G38190
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Death (1802); Vascular Dissection (3160)
Date of Event	03/07/2020
Type of Reportable Event	Death
Event or Problem Description
Description of event according to initial reporter: information received 03aug2020 indicated patient was deceased.03aug2020, the dm was requested to obtain additional information from the physician to know if the physician feels our device caused or contributed to the death of the patient.06aug2020, the dm responded with information from the physician indicating ¿i don¿t know honestly but probably.She came back a month later with an ascending dissection that wasn¿t there on her post op day 2 cta.So it wasn¿t directly related to the device in that it happened immediately but obviously the graft and tevar most likely played a part.¿ additional information received 06aug2020 from the physician: "i mean to say i think it's surgery related but i don't think it has to do with the cook device itself.I don't think if i had used another vendor there'd be a different outcome if that makes sense." patient outcome: death.

• 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: 10420999
• Report Number: 3005580113-2020-00400
• Device Sequence Number: 2816921
• Product Code: MIH
• UDI-Device Identifier: 10827002381909
• UDI-Public: (01)10827002381909(17)221218(10)E3933427
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/18/2020
• Report Date (Section F): 08/17/2020

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: Health Professional
• Device Expiration Date: 12/18/2022
• Device Model Number: G38190
• Device Catalogue Number: ZTA-PT-38-34-217-W
• Device Lot Number: E3933427
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2020
• 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: Death