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

Model Number	G47442
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to the initial reporter: post deployment of zdeg, green sleeve and trigger wires would not release.Excessive force required to release trigger wires causing dilator and device to migrate distally resulting in encroachment of the celiac artery.Subsequent stent implantation was required to preserve celiac artery.Patient outcome: no unintended device remained inside the patient´s body.The patient did require an additional procedure due to occurrence.A celiac covered stent was placed to protect celiac from stent migration and mal-perfusion.According to the initial reporter, the patient did not experience any adverse effects 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: 12852561
• Report Number: 3005580113-2021-00142
• Device Sequence Number: 19793382
• Product Code: MIH
• UDI-Device Identifier: 10827002474427
• UDI-Public: (01)10827002474427(17)240302(10)E4079630
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/22/2021
• Report Date (Section F): 11/22/2021

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: 03/02/2024
• Device Model Number: G47442
• Device Catalogue Number: ZDEG-P-28-142-PF-US
• Device Lot Number: E4079630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2021
• Date Device Manufactured: 03/02/2021
• 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
• Patient Weight: 73 KG
• Date Report Sent to FDA: 11/22/2021