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

Catalog Number ZDEG-PT-38-154-PF-US

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.G4) pma/510(k): p180001.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 Description

Description of event according to initial reporter: doing an aortic stent graft when it came time to release the green trigger would not pull back.They were able to get space between the white & green wire to deploy successfully.Additional information received 21sep2023: - i do not believe the green trigger wire release knob was rotated during the pull back.After the initial pull with no release, the doctor tried to slightly rotate the green mechanism back and forth while pulling back to try and expose the trigger wires.- the doctor ended up camping the white piece on the positioner with hemostats and used that to help pull the green mechanism back far enough to expose the trigger wires.This was done with a lot of force.Patient outcome: no ham to patient.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: a male patient underwent a procedure with an implantation of a zdeg-pt-38-154-pf-us (complaint device) stent graft in the thoracic aorta.When they came to release the trigger wire, the green knob would not pull back.It is reported that ¿after the initial pull with no release, the doctor tried to slightly rotate the green mechanism back and forth while pulling back to try and expose the trigger wires.¿ it is mentioned that ¿they were able to get space between the white & green wire¿¿, because ¿the doctor ended up camping the white piece on the positioner with hemostats and used that to help pull the green mechanism back far enough to expose the trigger wires.This was done with a lot of force¿.The stent graft was then deployed successfully, and landed in the intended location.There was no harm to patient.Review of the device history record found that all discovered non-conformances were properly dispositioned before release and no indication that the device was produced outside of specification.The complaint device (zdeg-pt-38-154-pf-us) was returned without sheath, shipping stylet, protection tube and stent graft.Only a small part of the steel wire was returned (attached to the green release knob).Device evaluation was performed.Per the device evaluation several scratches/marks were observed on the handle main body.Some scratches/marks marked are relatively deep and located near by the wire hole, but in the direction towards the tip.There are two sets of these marks located on opposite sides on the handle main body.Other scratches/marks marked is located next to the wire hole, going in a counterclockwise and roughly right-angled direction away from the wire hole (seeing from the hub).The most severe groove marks observed on the handle main body could likely have been caused by the reported use of hemostats, due to the symmetry of the marks and their location on the main handle body.Other marks, located next to the wire hole going in a counterclockwise direction indicate that a rotation of the green release knob was performed during attempt to retract the release wires.It is unknown whether factors such as strong resistance during retraction of wires e.G., due to friction, contributed to an unintended rotation of the green release knob, or if the rotated green release knob caused the difficulties experienced during withdrawing of the green release knob.Rotation of the green release knob could likely cause the wires to get stuck between the green release knob and the handle main body and contribute to the impeded movement.Per ifu ¿loosen the safety lock from the green trigger-wire release mechanism.Withdraw the trigger-wire in a continuous movement until the proximal end of the graft opens.Do not rotate the green trigger-wire knob¿.Internal actions have previously been initiated to prevent difficulties or inability in withdrawing the green trigger wire mechanism and corrective actions has been implemented.The corrective action of changing the inner diameter of the green release knob to prevent the nitinol wire to get stuck between the handle and green knob, if the green knob is rotated during retraction has been implemented.The complaint device is produced before this implementation.Furthermore.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 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
• 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; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: alex rahbek ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 17815591
• MDR Text Key: 324226053
• Report Number: 3002808486-2023-00249
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002474786
• UDI-Public: (01)10827002474786(17)251006(10)E4313612
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: ZDEG-PT-38-154-PF-US
• Device Lot Number: E4313612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2022
• 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 Sex: Male
• Patient Weight: 90 KG