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

Model Number	G38180
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Similar to device marketed under g4) 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.
Event or Problem Description
Description of event according to initial reporter: a female patient of undisclosed age underwent a thoracic endovascular aortic repair (tevar) descending thoracic aorta procedure in which the zenith alpha thoracic endovascular graft proximal tapered components, g38180, was used.After unsheathing graft and distal trigger wire release from graft, distal end of graft did not open completely.Balloon was placed in distal part of graft and inflated to open graft completely.
Additional Manufacturer Narrative
Manufacturer¿s ref# (b)(4).Summary of investigational findings: after unsheathing zta-pt-38-34-167-w and distal trigger wire release from graft, distal end of graft did not open completely.Balloon was placed in distal part of graft and inflated to open graft completely.There were no other issues during the deployment/release of the stent graft.The actuation of the handle was reported to go as normal.Review of the device history record gave no indication of the device being produced out of specification.The complaint device was returned without shipping stylet and stent graft.Device evaluation found that the valve assembly with the captor sleeve was not docked with the black telescopic gripper some of the gray positioner was visible from the sheath.These indicate that the sheath was not completely withdrawn by the user.During evaluation, it was attempted to rotate the blue rotation handle; it was not possible neither clockwise nor anticlockwise.The blue rotation handle was dissembled, and the threated wire knob was observed to be docked with the stop tube, indicating that the blue rotation handle was rotated completely by user.Furthermore, the stop tube was disassembled for further inspection and was found to be severely deformed.This indicate that excessive force was used to try and rotate the blue handle even after this was rotated to stop.Based on the provided information and device evaluation it is likely that the user rotated the blue rotation handle before having fully completed the withdrawal of the sheath, causing the incomplete expansion of the distal end of the stent graft as it was likely caught in the sheath.The ifu (instructions for use) states ¿withdraw the sheath until the graft is fully expanded and the valve assembly with the captor sleeve docks with the black gripper.While holding the black gripper, turn the black safety-lock knob in the direction of the arrows until a slight click is felt, indicating that the blue rotation handle is engaged.Make sure the black safety-lock knob is in the unlocked position.Under fluoroscopy, turn the blue rotation handle in the direction of the arrow until a stop is felt.This indicates that the uncovered stent and proximal end of the graft have opened and that the distal attachment to the introducer has been released".Consequently, the cause of the event is related to incorrect deployment sequence of 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 ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS
• 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 ; DK 4632
• Manufacturer Contact: louise baekmand ; sandet 6; bjaeverskov 4632 ; DK 4632 ; 56856868382
• MDR Report Key: 20503523
• Report Number: 3002808486-2024-00226
• Device Sequence Number: 8589961
• Product Code: MIH
• UDI-Device Identifier: 10827002381800
• UDI-Public: (01)10827002381800(17)270514(10)E4545580
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2025

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 Model Number: G38180
• Device Catalogue Number: ZTA-PT-38-34-167-W
• Device Lot Number: E4545580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• 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: Female