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

Model Number	G35375
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter: a female patient of undisclosed age underwent a complex endovascular aortic arch repair procedure in which the zenith alpha thoracic endovascular graft proximal components, g35375, was used.The physician needed to place a 46mm alpha graft to provide overlap between an existing tevar graft and a cmd graft.The 46 alpha device was placed in a good position providing good overlap between the 2 grafts.Deployment of the graft was per ifu.When releasing the proform attachment- the graft appeared to fold upon itself at the proximal end (where proform is located).The physician was able to force the graft into proper position (unfold the proximal end) with a molding balloon.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient did not require any additional procedures due to this occurrence.Additional information 20oct2021: no planning available.Md was not happy with the proximal landing zone of the cmd device and decided to add an additional graft to cover the proximal edge of cmd.The proximal landing zone was in a straight segment of aorta.The distal landing zone was below the angle.Graft was 50/50 above/below the aortic angle.Nothing particularly unusual with the anatomy.Cmd graft: thoraco-abdominal side branch lot: ac1081727.Guidewires/catheters/sheaths/balloons used during the procedure- lot #'s not available.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient did not require any additional procedures due to this occurrence.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL 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: 12814467
• Report Number: 3005580113-2021-00139
• Device Sequence Number: 5511624
• Product Code: MIH
• UDI-Device Identifier: 10827002353753
• UDI-Public: (01)10827002353753(17)240323(10)E4089517
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/15/2021
• Report Date (Section F): 11/15/2021

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: 03/23/2024
• Device Model Number: G35375
• Device Catalogue Number: ZTA-P-46-179-W
• Device Lot Number: E4089517
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/18/2021
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2021
• Date Device Manufactured: 03/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 11/15/2021