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

Model Number	G47480
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Pma/510(k): p180001.Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: difficult removing the trigging wires.The graft jumped back really far according to the ct.The physician was able to re-advance it and get the graft within 5mm's of the intended target landing zone.During this process, one of the stents enfolded on itself (this caused a loss of graft length).The graft was ultimately placed successfully and laid flat according to follow-up ct images.21sep2021: additional info received: once the safety portion was unscrewed, the wire would not release out of the devise.The physician had to pull extremely hard to remove them.Patient outcome: had to go back couple days later due to leak.The physician had to perform a full de-branching.An additional stent was placed.Had a hard time waking the patient up.The final outcome is that the patient did not survive.The patient expired.
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
Manufacturer ref# (b)(4).E2402 - appropriate term/code not available for unspecified leakage.Summary of investigational findings: a 73 year-old man underwent a thoracic endo vascular aortic repair (tevar) procedure with a zdeg-pt-38-30-159-pf-us (complaint device).The physician experienced difficulty when removing the trigger wires and had to pull extremely hard to remove them.The graft jumped back really far according to the ct.The physician was able to re-advance it and get the graft within 5mm's of the intended target landing zone.During this process, one of the stents enfolded on itself (this caused a loss of graft length).The graft was ultimately placed successfully and laid flat according to follow-up ct images.A couple of days later the patient underwent additional procedure due to unspecified leakage.It is unknown what kind of procedure.It is stated that the patient expired shortly after.A clinical assessment of the provided information was evaluated.Per the clinical assessment the information in this complaint is very sparse since no imaging was available, and no product was returned.Therefore it is impossible to establish any link between the encountered deployment difficulties and the deadly outcome.The operator has not provided any response to whether the green trigger wire knob had been rotated to stop or if the knob had been turned during the release of the trigger wires.Review of the device history record gave no indication of the device being produced out of specification.Per the instructions for use sent with the device, the green trigger wire knob should be withdrawn in a continuous movement until the proximal end of the graft opens.The green trigger wire knob should not be rotated.Based on the provided information, it was not possible to determine the cause of the reported failure.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 TAPERED 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 ; 56868686
• MDR Report Key: 12539181
• Report Number: 3002808486-2021-01841
• Device Sequence Number: 17163661
• Product Code: MIH
• UDI-Device Identifier: 10827002474809
• UDI-Public: (01)10827002474809(17)230908(10)E4015432
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2022

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: 09/08/2023
• Device Model Number: G47480
• Device Catalogue Number: ZDEG-PT-38-30-159-PF-US
• Device Lot Number: E4015432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2020
• 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: Death
• Patient Sex: Male