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 Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).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.
Event or Problem Description
Description of event according to initial reporter: the physician had trouble with the device.The dissection triggerwire would not release without requiring a lot of pressure.Once released the landing zone was nailed however it caused a slip which in turn caused a draw-back of a couple of centimeters.The end result of the graft placement was not at its intended landing zone due to the wire release pulling the device back.Safety lock was removed prior to green knob removal.Slight angulation in mid thoracic descending aorta.No severe angulation or tortious vessels.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Summary of investigational findings: a 69-year-old female patient was treated with a zdeg-p-36-204-pf-us device (complaint device).The physician had trouble with the device as the dissection trigger wire would not release without requiring a lot of pressure.Once the graft was released, the placement was not at its intended landing zone (draw-back of a couple of centimeters) due to the wire release pulling the device back.Reportedly no interventional procedure was performed due to this occurrence and no adverse event to the patient.Slight angulation in mid thoracic descending aorta was reported, but no severe angulation or tortious vessels.Per the ifu ¿loosen the safety lock from the green trigger-wire release mechanism.Withdraw the trigger-wire until the proximal end of the device opens.Do not rotate the green trigger-wire knob.The distal end is still attached.Continue to withdraw the trigger-wire until the distal end opens.Withdraw the trigger-wire completely¿.Per the reported information the green release knob was not rotated when pulled back.As no complaint device was returned for investigation, it has not been possible to determine the cause of the reported event.However, complaint history shows that if the green knob is rotated it might lead to difficulties when pulling back the green knob.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.
Event or Problem 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
• 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: 16002969
• Report Number: 3002808486-2022-01057
• Device Sequence Number: 6678691
• Product Code: MIH
• UDI-Device Identifier: 10827002474557
• UDI-Public: (01)10827002474557(17)251107(10)E4326604
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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: 11/07/2025
• Device Model Number: G47455
• Device Catalogue Number: ZDEG-P-36-204-PF-US
• Device Lot Number: E4326604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2022
• 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 Age: 69 YR
• Patient Sex: Female