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

Model Number	G47452
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Description of event according to initial reporter: the product malfunctioned during deployment of the device.Following the unsheathing/initial deployment of the 34mmx204mm zdeg endograft, attempt was made to fully deploy the device by releasing the trigger wire mechanism.The mechanism would not release, even with repeated attempts to remove by hand.Kelly clamps were then used to manually grab individual trigger wires which were exposed enough to be grasped, they were then manually pulled, and device was deployed.Patient outcome: the complainant did not report any adverse effects to the patient due to this occurrence.
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Pma/510(k) p180001.Investigation is still in progress.This report is required by the fda under 21cfr 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.
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Summary of investigational findings: a 62-year-old male patient underwent tevar to treat a thoracic aortic dissection.I was reported that following the unsheathing/initial deployment of the 34mmx204mm zdeg endograft, attempt was made to fully deploy the device by releasing the trigger wire mechanism - the mechanism would not release, even with repeated attempts to remove by hand.Kelly clamps were then used to manually grab individual trigger wires which were exposed enough to be grasped, they were then manually pulled, and device was deployed/released.No adverse effects to the patient was reported.Review of the device history record gave no indication of the device being produced out of specification.The zdeg-p-34-204-pf-us complaint device was returned without shipping stylet, stent graft and protection tube.The sheath was separated from the introduction system when returned.The green release knob was located 17.5mm from the initial position.During the device evaluation the green release knob was removed from handle main body for further inspection.Groove marks were observed on the handle main body, going from the wire hole against the hub end and counterclockwise (seen from the hub) against the hub end.Scrape offs were noticed on the nitinol wires, near the green release knob.The angel between the position of the green release knob when returned and the initial position is roughly assessed to be 140-150° counterclockwise.The groove marks on main body handle indicate that the green release knob was rotated during retraction.The rotation of the green release knob possibly caught the nitinol wires between the handle and knob and caused the green release knob to get stuck.Per the instruction for use ¿loosen the safety lock from the green trigger-wire release mechanism.Withdraw the trigger-wire until the proximal end of the device opens.Do not rotate the green trigger-wire knob.¿ cook medical will continue to monitor for similar events.This report is required by the fda under 21cfr 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
• 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: 15757753
• Report Number: 3002808486-2022-01017
• Device Sequence Number: 6227058
• Product Code: MIH
• UDI-Device Identifier: 10827002474526
• UDI-Public: (01)10827002474526(17)240521(10)E4112244
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2023

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: 05/21/2024
• Device Model Number: G47452
• Device Catalogue Number: ZDEG-P-34-204-PF-US
• Device Lot Number: E4112244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/04/2022
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2021
• 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
• Patient Age: 62 YR
• Patient Sex: Male