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-42-210-PF-US

Device Problem Physical Resistance/Sticking (4012)

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

Event Type  malfunction  

Event Description

Description of event according to initial reporter: a patient of unknown gender and age underwent an unknown procedure in which the zenith tx2 dissection endovascular graft tapered component, g47487, was used.Customer had a zdeg used in a case this past week, that was incredibly challenging to remove the trigger wires.So much so they had to use clamps to pry it off.Customer, district manager were successful in removing them [trigger wires] and nothing adverse for the patient.

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.

• 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): COOK MEDICAL; sandet 6, dk-4632; bjaeverskov DK-46 32; DA DK-4632
• Manufacturer Contact: alex rahbek ; sandet 6, dk-4632; bjaeverskov DK-46-32 ; DA DK-4632 ; 30632506
• MDR Report Key: 18745633
• MDR Text Key: 336877521
• Report Number: 3002808486-2024-00034
• Device Sequence Number: 1
• Product Code: MIH
• 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
• Report Date: 02/21/2024

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-42-210-PF-US
• Device Lot Number: E4324136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2022
• 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