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

Model Number	G38075
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Remove (1528); Device Damaged Prior to Use (2284); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter: upon deployment of the modified graft, the delivery system was in the process of being removed when it seemed to get caught up on the graft as it was being removed.It was then noticed that the graft seemed to have moved distal to where it was released causing a shift from where it was originally at.The celiac artery was then unable to be cannulated.It was noted after finally removing the delivery system that one of the trigger wires was still able to be seen on the system where it should have been rotated into the handle.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 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: 12804386
• Report Number: 3005580113-2021-00137
• Device Sequence Number: 17308808
• Product Code: MIH
• UDI-Device Identifier: 10827002380759
• UDI-Public: (01)10827002380759(17)240413(10)E4096081
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2021
• Report Date (Section F): 11/11/2021

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: 04/13/2024
• Device Model Number: G38075
• Device Catalogue Number: ZTA-PT-32-28-178-W
• Device Lot Number: E4096081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/11/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2021
• Date Device Manufactured: 04/13/2021
• 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 Age: 73 YR
• Patient Sex: Male