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	Malposition of Device (2616)
Health Effect - Clinical Codes	Death (1802); No Code Available (3191)
Date of Event	03/07/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Description of event according to initial reporter: patient was deceased.The patient 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.¿ (pr306148).Additional information received 06aug2020: "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." additional information received on 23sep2020: an imaging review performed in pr306148 revealed the following: the left subclavian artery (lsa) was not occluded despite an amplatzer plug.As a result, a large type ia endoleak perfused the false lumen through the sma ostium.Filling of an unusual bronchiole artery at the sealing stent is further evidence of the type ia endoleak.(pr310104).Patient outcome: patient expired (b)(6) 2020.

• 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: 10700370
• Report Number: 3005580113-2020-00431
• Device Sequence Number: 3258838
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2020
• Report Date (Section F): 10/19/2020

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: 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?: Yes
• Distributor Facility Aware Date: 09/23/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/19/2020
• 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