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 Problems Improper or Incorrect Procedure or Method (2017); 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.

Manufacturer Narrative

Manufacturer ref# (b)(4).Pma/510(k): p180001.Blank fields on this form indicate the information is unknown or unavailable.Investigation is still in progress.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: it was reported that a male of unknown age underwent an emergency thoracic endovascular aortic repair (tevar) due to a ruptured dissection.The physician used a zdeg-p-34-204-pf-us device at first (complaint device) but it did not land in the right place due to operator error.The physician had to use a second device zdeg-p-34-154-pf-us ((b)(4)) 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 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.They then wanted to use a third device, zdeg-pt-34-159-pf-us ((b)(4)) but it would not track up because of the way that the second device was placed, so the procedure was then aborted.Review of the device history record gave no indication of the device being produced out of specification.Per the instructions for use sent with the device, the green trigger wire knob should be withdrawn in a continuous movement until the proximal end of the graft opens.The green trigger wire knob should not be rotated.This complaint is based on the provided information from customer.No imaging was available, or product was returned.Based on the provided information, the cause of the reported failure was due to unintended user error.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 13402205
• MDR Text Key: 289329125
• Report Number: 3002808486-2022-00049
• 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: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• 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
• Date Manufacturer Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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