MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number ZTA-P-46-233

Device Problems Accessory Incompatible (1004); Loss of or Failure to Bond (1068)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2023

Event Type  malfunction  

Event Description

Description of event according to initial reporter: graft introduced as normal.Extremely stiff to un-sheath and control the hight.Once the graft was ready to be released the rotation handle rotated much more than normal.Once it came to a stop the graft was still attached to the grey positioner.Bailout procedure was initiated and handle was removed to expose the wires.A mosquito clip was used to with draw them one by one but the force required was extremely high.This resulted in the graft landing 5cm short of where it was originally placed.When the delivery system came out it was clear the inner cannula and nose cone had completely separated from the grey positioner and they came out separately.Patient outcome: the patient did require extra thoracic component due to this occurrence.

Manufacturer Narrative

Manufacturers ref#(b)(4).Blank fields on this form indicate the information is unknown or unavailable.G4) similar to device marketed under pma/510(k): p140016.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.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: a zta-p-46-233 (complaint device) introduced as normal.Extremely stiff to un-sheath and control the hight.Once the graft was ready to be released, the rotation handle rotated much more than normal.Once it came to a stop the graft was still attached to the grey positioner.Bailout procedure was initiated, and handle was removed to expose the wires.A mosquito clip was used to withdraw them one by one, but the force required was extremely high.This resulted in the graft landing 5cm short of where it was originally placed.An extra thoracic component was required due to this occurrence.When the delivery system came out it was clear the inner cannula and nose cone had completely separated from the grey positioner, and they came out separately.Pre-implantation cta (computed tomography angiography) and implantation angiography were provided and reviewed by an imaging expert.Per the findings in the imaging review ¿from caudal to cranial, bare stent implantation near the lsa (left subclavian artery) trailing edge first required traversing a moderately to severely calcified and moderately tortuous right iliac arteries.The eia (external iliac artery) also was diffusely narrowed to 4.71mm x 5.7mm.Second, the delivery system needed to traverse a 98.9 degrees angle from the right iliac arteries into the abdominal aorta.Third, upon reaching the thoracoabdominal aortic junction, the aorta angled 59 degrees left lateral posterior and then kinked 90.3 degrees back towards the distal arch.Finally, to implant the bare stent near the lsa trailing edge, the sealing stent needed to reach the aorta¿s apex and the bare stent need to reach just beyond the apex¿.Per the impressions in the imaging review "the complaint of zta-p-46-223 implantation 5cm inferior to the intended implant site is confirmed.The eventual location should have and presumably provided a seal as the aneurysm¿s exclusion was completed through t-branch implantation one month later".The zta-p device was returned without stent graft, flexor sheath, shipping stylet, back-end cap and retaining clips.Device evaluation was performed.The device evaluation showed that the cannula tube was not attached to pin vise as intended.There were no signs of fracture or break on the cannula tube.The nitinol wires length and appearance did not show any signs of nonconformances.The rotation handle had been detached upon return.The back-end cap and retaining clips were not returned but would, under normal rotation, stop the threaded wire knob with trigger wires when it is rotated to stop by the use.The rotation-function of the handle was tested with the threaded wire knob, and nitinol wires and no nonconformance was observed.Nothing indicated that the rotation of the rotation handle could rotate more than normal.The device evaluation was not able to find the cause for the detachment of the cannula tube and pin vise.It is likely that the experienced difficult release of the wires and stent graft from the introduction system was caused by the detachment of the cannula tube from the pin vise.However, it is unknown whether tortuous anatomy and the right iliac artery calcification could have contributed to detachment of the cannula tube and pin vise.Consequently, it cannot be ruled out that difficult release of the wires and stent graft from the introduction system caused detachment of the cannula tube from the pin vise.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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
• Type of Device: 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: 17305142
• MDR Text Key: 319109658
• Report Number: 3002808486-2023-00196
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002347226
• UDI-Public: (01)10827002347226(17)260607(10)E4408525
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: ZTA-P-46-233
• Device Lot Number: E4408525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 11/13/2023
• Supplement Dates FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female