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

Model Number	G47457
Medical Device Problem Codes	Positioning Failure (1158); Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Pma/510(k) p180001 investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: "green trigger wire was difficult to pull out, and when it was pulled out the graft migrated back; device was removed from patient, and another graft (alpha) had to be placed in the originally intended location.The third graft was already planned as part of the procedure.Dm believes adhesive may have been a contributing factor (like it was stuck together)." patient outcome: the patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Summary of investigational findings: a male patient with dissection in thoracic aorta underwent thoracic endovascular repair.It was reported that anatomy was described as `pretty clean`.The zdeg-p-38-154-pf-us (complaint device) was used.During the procedure the green trigger wire was difficult to pull out.When it was pulled out the device migrated approx.2 cm back.A zta-p-38-117-w was used in the procedure to compensate the migration.The third device zdes-46-185-us was also used in the procedure as it was planned.No adverse effects to the patient were reported.The zdeg-p-38-154-pf-us without shipping stylet, stent graft, peel away and protective tube was returned and evaluated.It was found that the green release knob moved easily when it was in the correct position.Based on evaluation of the returned product the difficulties in pulling the green release knob possibly could be caused by rotating of the knob during deployment, since the scratch marks on the main body handle and on the green release knob.Review of the device history record gave no indication of the device being produced out of specification.The instruction for use states: loosen the safety lock from the green trigger-wire releases mechanism.It also states that the green trigger-wire knob should not be rotated.Based on the provided information and evaluation the difficulties in pulling the green release knob was possibly related to the unintended use error.It is noted that zta devices are not indicated for the endovascular treatment of patients with dissections.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
• MDR Report Key: 10022990
• Report Number: 3002808486-2020-00506
• Device Sequence Number: 19567387
• Product Code: MIH
• UDI-Device Identifier: 10827002474571
• UDI-Public: (01)10827002474571(17)220819(10)E3886709
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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: 08/19/2022
• Device Model Number: G47457
• Device Catalogue Number: ZDEG-P-38-154-PF-US
• Device Lot Number: E3886709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2020
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention