MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G47448
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter: after fully unsheathing of zdeg, white thumbscrew was removed from green trigger wire mechanism & physician attempted pulled green trigger mechanism.Mechanism would not come off.Had to troubleshoot to remove wires, dislodging graft from original landing zone.Put another piece in following.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 TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT
• 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: 14052778
• Report Number: 3005580113-2022-00042
• Device Sequence Number: 4821415
• Product Code: MIH
• UDI-Device Identifier: 10827002474489
• UDI-Public: (01)10827002474489(17)241230(10)E4202789
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/08/2022
• Report Date (Section F): 04/08/2022

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: 12/30/2024
• Device Model Number: G47448
• Device Catalogue Number: ZDEG-P-32-142-PF-US
• Device Lot Number: E4202789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/10/2022
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2022
• Date Device Manufactured: 12/30/2021
• 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: 65 YR
• Patient Sex: Male
• Date Report Sent to FDA: 04/08/2022