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

Model Number	G47475
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Description of event according to initial reporter: once the graft was completely unsheathed, the physician went to finish deploying the graft by releasing the trigger wire, but was met with a lot of resistance and could not remove the trigger wire mechanism.Her partner scrubbed in and was able to inch off the trigger wire with use of tremendous force---way more than has been necessary in the past.As the green trigger wire mechanism was finally being inched off the white handle, we could see that one of the trigger wires was somehow wedged in between the white handle and green trigger wire mechanism.That seemed to be causing the immense amount of friction/difficulty in removing the trigger wires.The graft deployed fully after trigger wires were removed.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient did not require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Occupation: unknown.Pma/510(k): p180001.Investigation is still in progress.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Summary of investigational findings: a 78-year-old male patient with an intramural hematoma underwent a thoracic endovascular aortic repair, where a zdeg-pt-36-199-pf-us (complaint device) was used.Once the graft was completely unsheathed, the physician went to finish deploying the graft by releasing the trigger wire, but experienced a lot of resistance and could not remove the trigger wire mechanism.Another physician was able to inch off the trigger wire with use of tremendous force.As the green trigger wire mechanism was finally being inched off the white handle, it was noticed that one of the trigger wires was somehow wedged in between the white handle and green trigger wire mechanism.That seemed to be causing the immense amount of difficulty in removing the trigger wires.The graft was deployed fully after trigger wires were removed.It was reported that the patient did not experience any adverse effects to this occurrence.Review of the device history record gave no indication of the device being produced out of specification.Per the instructions for use, 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.Also per ifu make sure that all trigger-wires are removed prior to withdrawal of the introduction system.This complaint is based on the provided information from customer.No imaging was provided and no device was returned.Based on the provided information, it was not possible to determine the cause of the reported failure.However, unintended user error could possibly contribute to the reported event.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 12834325
• Report Number: 3002808486-2021-01958
• Device Sequence Number: 4780320
• Product Code: MIH
• UDI-Device Identifier: 10827002474755
• UDI-Public: (01)10827002474755(17)220830(10)E3891411
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2022
• Device Model Number: G47475
• Device Catalogue Number: ZDEG-PT-36-199-PF-US
• Device Lot Number: E3891411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 03/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2019
• 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
• Patient Sex: Male