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

Model Number G47452

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2022

Event Type  Injury  

Event Description

Description of event according to the initial reporter: patient came in emergently due to rupture ((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.((b)(4)) 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.The patient lost 1.5 units of blood and did not achieve proximal seal.Patient outcome: no information regarding the patient outcome has been received.No unintended section of the device remain inside the patient¿s body.

• Brand Name: ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 13545711
• MDR Text Key: 288491305
• Report Number: 3005580113-2022-00022
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002474526
• UDI-Public: (01)10827002474526(17)241222(10)E4201640
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G47452
• Device Catalogue Number: ZDEG-P-34-204-PF-US
• Device Lot Number: E4201640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/16/2022
• Distributor Facility Aware Date: 01/18/2022
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2022
• Date Device Manufactured: 12/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male