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

Model Number	G47455
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	12/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Description of event according to initial reporter: the trigger wires were all twisted up around the device.It took 15 to 20 minutes to remove the trigger wires.They eventually realized the wires were twisted around the device.One physician later said that he saw the other physician twisting the trigger wires instead of pulling them out.The procedure was successfully completed with the device in question.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).Blank fields on this form indicate the information is unknown or unavailable.Pma/510(k) p180001.Summary of investigational findings: a male patient underwent tevar where a zdeg-p-36-204-pf-us was used, to treat a descending aortic dissection.It is reported that during the procedure the trigger wires were all twisted up around the device.It took 15 to 20 minutes to remove the trigger wires.They eventually realized the wires were twisted around the device.One physician later said that he saw the other physician twisting the trigger wires instead of pulling them out.For clarification the following was requested ¿is it correct understood that the green knob was twisted which made the trigger wire to twist around the device?¿ and this was confirmed.The procedure was successfully completed with the device in question.The complaint device was not returned for investigation.Based on the provided information an exact cause for why the trigger-wire knob could not be pulled cannot be determined, but if rotated, the wires may get caught between the handle and the knob and consequently the release knob may stick.Instructions for use states ¿withdraw the trigger-wire in continuous movement until the proximal end of the device opens.Do not rotate the green trigger-wire knob.¿ an internal action is in progress to handle difficulties/inabilities in withdrawing the green trigger wire mechanism.No evidence to suggest that the device is not manufactured according to specification 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.

• 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: 16320660
• Report Number: 3002808486-2023-00039
• Device Sequence Number: 20997139
• Product Code: MIH
• UDI-Device Identifier: 10827002474557
• UDI-Public: (01)10827002474557(17)250907(10)E4301559
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/08/2023

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: 09/07/2025
• Device Model Number: G47455
• Device Catalogue Number: ZDEG-P-36-204-PF-US
• Device Lot Number: E4301559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2022
• 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 Sex: Male