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

Model Number	G47440
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter: patient came in for a dissection emergent case.During deployment or user aggression the graft landed distal to where the actual approx landing zone wanted to be ((b)(4)).The physician decided to use a device from another manufacturer to get more of a proximal seal.Delivered the device then distality he extended out the zdes-36-180-us.Upon final run he was satisfied with the final angio.Fast forward to recently within the last week the patient had to come back in with a type a dissection to where they had to build the arch ((b)(4)).Patient outcome: the patient was prolonged hospitalized for recovery.Furthermore, the patient had to return for complete arch repair.

• 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: 16141838
• Report Number: 3005580113-2023-00002
• Device Sequence Number: 20537295
• Product Code: MIH
• UDI-Device Identifier: 10827002474403
• UDI-Public: (01)10827002474403(17)250214(10)E4221147
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 01/11/2023
• Report Date (Section F): 01/09/2023

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: 02/14/2025
• Device Model Number: G47440
• Device Catalogue Number: ZDEG-P-26-136-PF-US
• Device Lot Number: E4221147
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/23/2022
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/09/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2023
• Date Device Manufactured: 02/14/2022
• 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