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

Catalog Number ZDEG-P-36-204-PF-US

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 12/14/2023

Event Type  malfunction  

Event Description

Description of event according to initial reporter: difficult to release the safety wires.No tortuosity.The junction was not tight.The graft was landed at the level at the location of the subclavian.Patient outcome: the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Manufacturers 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 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.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: the green trigger-wire release mechanism of the zdeg-p-36-204-pf-us was difficult to release.Safety pin removed, dilator was stabilized, green sleeve was pulled longitudinally but with great difficulty.No forceps were used.Access was not tight, and no obvious tortuosity was noted.The stent graft landed in the planned target zone.Per the reported information, the green trigger-wire knob was not rotated when it was withdrawn.The patient did not experience any adverse effects due to this occurrence.Review of the device history record gave no indication of the device being produced out of specification.An internal action has previously been initiated to address difficulties or inability in withdrawing the green trigger wire mechanism.As a result of the internal action a change of the inner diameter of the green release knob has been implemented recently, to prevent the nitinol wire to get stuck between the handle and green knob, if the green knob is rotated during retraction.The complaint device is produced before this implementation.The complaint device was not returned for evaluation and no imaging was provided.Based on the received information, it was not possible to determine the cause of difficult release of the green trigger-wire release mechanism.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 STRAIGHT 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: 18462340
• MDR Text Key: 332268654
• Report Number: 3002808486-2024-00005
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002474557
• UDI-Public: (01)10827002474557(17)250516(10)E4258156
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

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-P-36-204-PF-US
• Device Lot Number: E4258156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2022
• 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