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
Medical Device Problem Codes	Off-Label Use (1494); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).This event is no longer considered reportable after investigation summary of investigational findings: a patient of unknown gender and age underwent a procedure in which a zdeg-pt-42-210-pf-us (complaint device), was used.The customer/district manager has described the issue as: ¿we had a zdeg used in a case this past week that was incredibly challenging to remove the trigger wires.So much so they [end user] had to use clamps to pry it off.Need to report the issue.We were successful in removing them [trigger wires] and nothing adverse for the patient.¿ the customer/district manager has answered that there was calcification in aorta and that some tortuosity was present but that it was ¿relatively normal given the aneurysmal disease¿.The procedure was off label as ¿physician used this device for a 4 vessel pmeg (physician modified endograft).Prior gore excluder with a type 1 a endoleak.This graft was landed into the gore device to create the distal seal.We extend proximally through this graft after trigger wire removal to create proximal seal.¿ prior to procedure the device was modified in the following way: ¿removed from sheath, graft altered with added 4 fenestrations, then resheathed.Again, experienced operator with this technique and has used this platform many times without the symptom of having the trigger wires be this difficult to remove.¿ when asked to elaborate the district manager responded that: ¿this physician uses chromic gut suture for the constraining ties, therefore he does nothing to alter trigger wires, nor does he make any cuts in cannula.The only modifications are those 4 fenestrations made to the graft.The delivery system is not altered at all.¿ cook research incorporated (cri) has performed imaging review based on a single complaint report and pre-procedure imaging.The imaging review concludes that access vessel anatomy is moderate (left) to severely (right) tortuous and that the gore excluder limbs would have limited the iliac arteries conformability which could have increased friction with the delivery sheath.Device evaluation was performed on the returned zdeg-pt-42-210-pf-us.This was returned without protection tube, shipping stylet and stent graft.The device evaluation concluded that: - "hole 2 on the gray positioner was significantly damaged and had a form of a burr.A deep longitudinal slit was observed going from hole 2 to the proximal end of the gray positioner.Additionally, the visible part of uat had several marks possibly originating from twist of material.The device evaluation could not determine, when and how these damages occurred." - "the steel wire was observed to be twisted around one of the nitinol wires, which could have caused the reported friction during retraction of the trigger ¿ wire release mechanism.However, it was not possible to determine an exact cause of difficult release of the green trigger-wire release mechanism during device evaluation." as part of evaluation, the returned device was examined by product sustaining engineers.Per this evaluation, the damages are seen mainly around the tip of the gray positioner and in the way the stainless steel wire has been permanently deformed at its proximal end through twisting around a nitinol wire.There were also noticed a few marks at the handle.Additionally, per product sustaining evaluation, the twisting of the wire and the damages on the gray positioner are quite substantial and indicate a significant force has been applied to the device.Per the product sustaining conclusion, it has not been possible to identify an exact cause to the failure, however it is most likely that the damages occurred during fenestration at the physician, as that is an uncontrolled sequence of events, performed on a device not designed to be partially released, manipulated and then re-sheathed.Based on the reported information, device evaluation, assessment of the complaint device by product sustaining and imaging review, it has not been possible to determine an exact cause for the difficulty removing the trigger wires.Imaging review found that the anatomy of access vessel was moderate to severely tortuous and this in combination with the already implanted gore excluder could have caused increased friction in both advancement and deployment of the device.Evaluation of the returned device found that the steel wire was twisted around one of the nitinol wires which could also have caused the reported friction during retraction of the trigger wires.It is assessed that it is more likely this twist of wires occurred during the fenestration by the physician.It is assessed that the most likely cause is that an error was made during the off-label fenestration of the device that led to an issue that caused friction/resistance when deploying the device.Device modification is not supported by the instructions for use or clinical testing of the device.It should also be noted that the device was used as an abdominal device to treat a thoracoabdominal aneurysm and in a combination with a gore device, which is outside the indications for the device.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 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; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: alex rahbek ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 18745633
• Report Number: 3002808486-2024-00034
• Device Sequence Number: 6933788
• Product Code: MIH
• UDI-Device Identifier: 10827002474878
• UDI-Public: (01)10827002474878(17)251028(10)E4324136
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2025
• Device Catalogue Number: ZDEG-PT-42-210-PF-US
• Device Lot Number: E4324136
• 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: 02/05/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2022
• 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: Unknown