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

Model Number	G47442
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Description of event according to the initial reporter: post deployment of zdeg, green sleeve and trigger wires would not release.Excessive force required to release trigger wires causing dilator and device to migrate distally resulting in encroachment of the celiac artery.Subsequent stent implantation was required to preserve celiac artery.Patient outcome: no unintended device remained inside the patient´s body.The patient did require an additional procedure due to occurrence.A celiac covered stent was placed to protect celiac from stent migration and mal-perfusion.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Investigation is still in progress.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
Additional information received 27dec2021: trigger wires were released by removing the trigger wire release mechanism.Per deployment guidelines the safety pin was removed and then trigger wire release mechanism was pulled but did not budge.Safety wire release ¿green sleeve¿ was rotated slightly then removed by pulling.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Summary of investigational findings: it was reported by email that a 79-year old female with a dissection in thoracic aorta underwent an emergency thoracic endovascular aortic repair.A zdeg-p-142-pf-us (complaint device) was used in the procedure.It was reported, that the green trigger wire mechanism was unable to be removed from the delivery system.While attempting to remove the green trigger wire from the delivery system, the graft was inadvertently repositioned 1- 2 cm resulting in an inadequate proximal landing.As a result, the patient required an additional procedure (unknown stent implantation) to preserve celiac artery.The patient experienced no adverse effect after the procedure.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, it was not be possible to determine the cause of the reported failure.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 STRAIGHT 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: 12826158
• Report Number: 3002808486-2021-01952
• Device Sequence Number: 4364220
• Product Code: MIH
• UDI-Device Identifier: 10827002474427
• UDI-Public: (01)10827002474427(17)240302(10)E4079630
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2022

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: 03/02/2024
• Device Model Number: G47442
• Device Catalogue Number: ZDEG-P-28-142-PF-US
• Device Lot Number: E4079630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 12/27/2021; 04/19/2022
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 01/06/2022; 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2021
• 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 Age: 79 YR
• Patient Sex: Female
• Patient Weight: 73 KG