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

Model Number	G35355
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Common name: mih system, endovascular graft, aortic aneurysm treatment product code: mih.
Event or Problem Description
Initial reporter event description: alpha device used for a thoracic aneurysm.Looks like a type 3 endoleak at steepest curve of the arch.Reintervention on (b)(6) 2019 to implant another alpha (zta-p-38-167-w) to seal off leak.The patient no longer has a leak.First implant was tuesday, (b)(6) 2019.The doctor scanned the patient (b)(6) 2019 and saw an endoleak.He wasn¿t sure if it was a type 1a or type 3.He lined the graft with a new alpha on (b)(6) 2019.The patient does not have a leak any more.The graft landed in zone 2, just distal to the carotid artery.Patient outcome: the patient did require additional procedures due to this occurrence: an additional implant of an alpha device was scheduled for (b)(6) 2019 to seal off endoleak.A zta-p-38-167-w was implanted on (b)(6) 2019.Doctor is happy with final result.

• Brand Name: ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 9566050
• Report Number: 3005580113-2020-00051
• Device Sequence Number: 19683732
• Product Code: MIH
• UDI-Device Identifier: 10827002353555
• UDI-Public: (01)10827002353555(17)221112(10)E3919966
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2020
• Report Date (Section F): 01/08/2020

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: 11/12/2022
• Device Model Number: G35355
• Device Catalogue Number: ZTA-P-36-161-W
• Device Lot Number: E3919966
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/16/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2020
• 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: Required Intervention
• Date Report Sent to FDA: 01/08/2020