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

Catalog Number ZTA-PT-40-36-167-W

Device Problem Mechanical Jam (2983)

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

Event Date 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref (b)(4).Blank fields on this form indicate the information is unknown or unavailable.This event was considered reportable after investigation completed 07mar2024.Summary of investigational findings: during deployment of the zta-pt-40-36-167-w (complaint device) the handle did not click when turning.The physician reported that ¿the handle was disassociated¿ elaborating that the trigger wires were not pulling back as he was turning the handle.Troubleshooting was performed and the physician was able to land the device in the planned target zone.It is unknown if the blue rotation handle was rotated to full stop.Review of the device history record gave no indication of the device being produced out of specification.No imaging was provided, and no device was returned.According to the ifu (instructions for use) ¿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¿.There is no step in the ifu describing the click sound of the blue rotation handle as an indicator for the release mechanism.Based on the provided information it has not been possible to establish the cause of the inability to full release of the stent graft.An internal action was previously initiated to address the nonconformance on nitinol release wires and if the nonconformance could influence release of stent graft.The action is still ongoing.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 Description

Description of event according to initial reporter: the attached graft had issues with deployment.We most deployed this graft first and the handle did not click when turning (han said the handle was disassociated).So he had to pop the back of the handle off and pull the trigger wires.".

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED 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: alex rahbek ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 18901617
• MDR Text Key: 337621796
• Report Number: 3002808486-2024-00048
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002381916
• UDI-Public: (01)10827002381916(17)260926(10)E4452766
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: ZTA-PT-40-36-167-W
• Device Lot Number: E4452766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2023
• 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