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-36-28-159-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)
Date of Event	09/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter: on friday, 29sep2023 we had a zdeg 36-28-159; it took two strong male surgeons multiple ¿turns¿ at trying to pull of the trigger wires to finally get them to go.The amount of force needed is definitely a risk to the patient: if one component of the graft ¿slips¿ or moves unexpectedly, the force could have serious consequences.In this case, the gray positioner moved distally, causing the graft to come down unexpectedly in the patient.The physicians were able to recover, but it was exceptionally difficult, and i believe changed the outcome of the procedure.Additional information received 03oct2023 the amount of force needed to deploy the trigger wires cause the gray positioner, and in turn the graft to move down during the procedure; thankfully two fenestrations had been cannulated previously which helped anchor the graft in place, but it still moved distally in the aorta and cause concern and time to determine how to fix the moved graft (they did re-balloon the graft and try and push up on the graft, but with no success).Additional information received 06oct2023: it was placed as any zdeg or other device is placed; the only difficulty was in the final deploying of the device due to extremely ¿tight¿ trigger wire mechanism.There was difficulty cannulating the celiac fenestration; the sma and a renal artery had already been cannulated.The plan was to fully deploy the graft to see if that helped with the 3rd and final vessel.Due to the difficulty of the trigger wires, and the force needed to remove them, the graft appeared to move distally in the aorta.Ultimately, there was good seal and perfusion of the celiac, and the decision was made to proceed with the case.There was no adverse impact to the patient.The device was deployed successfully implanted.The device was modified prior to implant 3 fenestrations were made.Patient outcome: procedure was in hospital where patient had been admitted emergently; his admission was not delayed related to this no adverse effect on or for the patient; only adverse impact on the case was the time involved to assure that everything could proceed.
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).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.
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) summary of investigational findings: a male patient with a contained rupture in the visceral segment of aorta underwent evar (endovascular aortic repair), where a zdeg-pt-36-28-159-pf-us (complaint device) was used.The complaint device was modified by physician prior to implant, where 3 fenestrations for celiac artery, sma (superior mesenteric artery) and renal artery were made.Per the response from rep ¿i was not present for that process, but i imagine the graft was unsheathed, modified and re-sheathed¿.The green trigger-wire release mechanism of the complaint device was very hard to remove.It took two strong male surgeons multiple ¿turns¿ at trying to pull of the trigger wires to finally get them to go.It resulted in the gray positioner moved distally, causing the stent graft to come down unexpectedly in the patient.Re-ballooning of the stent graft was performed to push up on the graft, but with no success.There was difficulty cannulating the celiac fenestration.The sma and a renal artery had already been cannulated.The plan was to fully deploy the graft to see if that helped with the 3rd and final vessel.Due to the difficulty of the trigger wires, and the force needed to remove them, the graft appeared to move distally in the aorta.Ultimately, there was good seal and perfusion of the celiac, and the decision was made to proceed with the case.No adverse effects on the patient were reported, only adverse impact was the time involved to assure that everything could proceed.Review of the device history record gave no indication of the device being produced out of specification.The complaint device was not returned for the investigation and no imaging was provided.As per the reported information, the stent graft was unsheathed, modified and re-sheathed, it is assumed that no modification was performed on the trigger wires.Based on the received information it has not been possible to determine the cause of difficult release of the green trigger-wire release mechanism.It is noted that the zdeg device was modified and implanted in thoracoabdominal aorta.Stent graft modifications is not supported by the instructions for use or clinical testing of the device.Furthermore, according to the ifu (instructions for use) zdeg is indicated for the endovascular treatment of patients with type b aortic dissection.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; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: henriette s. christiansen ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 17903031
• Report Number: 3002808486-2023-00255
• Device Sequence Number: 12652554
• Product Code: MIH
• UDI-Device Identifier: 10827002474762
• UDI-Public: (01)10827002474762(17)260323(10)E4386842
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/22/2023

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: 03/23/2026
• Device Catalogue Number: ZDEG-PT-36-28-159-PF-US
• Device Lot Number: E4386842
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/29/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 11/22/2023
• Date Device Manufactured: 03/23/2023
• 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 Sex: Male