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

Model Number	G47448
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Pma/510(k): p180001.Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: after fully unsheathing of zdeg, white thumbscrew was removed from green trigger wire mechanism & physician attempted pulled green trigger mechanism.Mechanism would not come off.Had to troubleshoot to remove wires, dislodging graft from original landing zone.Put another piece in following.(b)(4).
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: the green trigger wire mechanism would not come off, why troubleshooting to remove the wires.The graft dislodged from landing zone and following another piece was put in.The zdeg device without shipping stylet, peel away, protecting tube, and stent graft was returned and due to the reported troubleshooting the handle main body had separated from the introducer system.The green release knob was located 13.5mm down the handle main body and rotated approx.95° counterclockwise from the hub.This combined with grooves noted in the handle main body close to the wire hole and counterclockwise against the back of the handle, indicates that the green release knob had been rotated during retraction.Said rotation may have caught the nitinol wires between the handle and the knob and caused the release knob to stick and consequently the reported difficulties in removing the trigger wires.Therefore, reference is made to the instructions for use specifying not to rotate the green trigger wire knob during withdrawal.However, appropriate actions have been initiated, too, to address the difficulties in withdrawing the green trigger wire mechanism.There are adequate controls in place to ensure the device was manufactured to specifications.It was assessed that because no non-conformances were detected, there is evidence that the dhr was fully executed.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: 14049467
• Report Number: 3002808486-2022-00239
• Device Sequence Number: 6044057
• Product Code: MIH
• UDI-Device Identifier: 10827002474489
• UDI-Public: (01)10827002474489(17)241230(10)E4202789
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/30/2024
• Device Model Number: G47448
• Device Catalogue Number: ZDEG-P-32-142-PF-US
• Device Lot Number: E4202789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male