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

Model Number	G47480
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Death
Event or Problem Description
Description of event according to initial reporter: difficult removing the trigging wires.The graft jumped back really far according to the ct.The physician was able to re-advance it and get the graft within 5mm's of the intended target landing zone.During this process, one of the stents enfolded on itself (this caused a loss of graft length).The graft was ultimately placed successfully and laid flat according to follow-up ct images.21sep2021: additional info received: once the safety portion was unscrewed, the wire would not release out of the devise.The physician had to pull extremely hard to remove them.Patient outcome: had to go back couple days later due to leak.The physician had to perform a full de-branching.An additional stent was placed.Had a hard time waking the patient up.The final outcome is that the patient did not survive.The patient expired.

• Brand Name: ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT TAPERED 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: 12562649
• Report Number: 3005580113-2021-00112
• Device Sequence Number: 1336809
• Product Code: MIH
• UDI-Device Identifier: 10827002474809
• UDI-Public: (01)10827002474809(17)230908(10)E4015432
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2021
• Report Date (Section F): 09/30/2021

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: 09/08/2023
• Device Model Number: G47480
• Device Catalogue Number: ZDEG-PT-38-30-159-PF-US
• Device Lot Number: E4015432
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/21/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/01/2021
• 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: Death