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

Model Number	G47451
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to the initial reporter: pt came in emergently due to rupture.(b)(6) (b)(6) 2022 ((b)(4)) the first device (g47452, lot e4201640) did not land in the right place due to operator error.A lack of upward force in holding the device into position caused the problem.On ((b)(6)) they had to use second device (g47451, lot e4202793) because the first device was not in the proper place.When they tried to use the second device, the trigger wires could not be pulled out.They used as much force as they could use.They then intentionally broke apart the device to get ahold of the wires to release the graft from the delivery system.While retracting the wires, the graft was pushed back out of place by blood flow forces.It was not sitting correctly within the first device.((b)(4)) a third device (g47470, lot e3923818) would not track up because of the way that the second device was placed.The procedure was then aborted.Patient outcome: according to the initial reporter, the patient did experience an adverse effects due to this occurrence.The patient lost 1.5 units of blood and did not achieve proximal seal.Unknown if the patient did require an 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: 13534327
• Report Number: 3005580113-2022-00021
• Device Sequence Number: 4073436
• Product Code: MIH
• UDI-Device Identifier: 10827002474519
• UDI-Public: (01)10827002474519(17)241230(10)E4202793
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/15/2022
• Report Date (Section F): 02/15/2022

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: G47451
• Device Catalogue Number: ZDEG-P-34-154-PF-US
• Device Lot Number: E4202793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/18/2022
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/15/2022
• 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 Sex: Male
• Date Report Sent to FDA: 02/15/2022