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-36-113-W
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturers ref (b)(4) g4) pma/510(k): p140016 summary of investigational findings: during the procedure where zta-p-36-113-w (complaint device) was used, the doctor was spinning the blue handle and the trigger wires were disassociated with the device.Per the additional information, it was not possible to rotate the handle to stop and therefore kept turning.The physician performed troubleshooting and was able to land the device in the planned target zone.The patient did not experience a delay and did not require any additional procedure due to this occurrence.It was reported that the stent graft was modified prior to procedure by unsheathing the stent graft and resheathing afterwards.The stent graft was not deployed (trigger wires were not released) to perform the modification before loading the stent graft again.Zta-p-36-113-w returned without shipping stylet, stent graft, backend cap, retaining clips, trigger wires and threaded wire knob, blue rotation handle and black safety-lock knob.The device evaluation found indentations on the tip of the sheath, several longitudinal scratches and minor pouching on the material of the sheath, which could possibly have occurred during advancement of the device through calcified patient anatomy.A hole and a longitudinal slit were observed on the uat near the gray positioner.The form and the appearance of these damages indicate that they were likely applied by cutting during the alteration of the device.Several scratches were observed on the distal part of the sliding rod close to the black telescoping gripper.It is not possible to determine whether the scratched have connection with the reported event.As the trigger wires and the blue rotation handle were not returned for evaluation, it is not possible to determine the cause of the inability to rotate the handle to stop and why the handle kept turning.Review of the device history record gave no indication of the device being produced out of specification.It should be mentioned that device modification is not supported by the instructions for use or clinical testing of the device.Based on the provided information and device evaluation, it was not possible to establish the cause of the reported event.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 or Problem Description
Description of event according to initial reporter: the attached device was used in a case today.Had patient contact.Was able to removed it successfully and no harm caused to patient.The doctor was spinning the blue handle and the trigger wires were disassociated with the device.We had to break back handle and manually release the trigger wires.Additional information received 07feb2024: was the graft altered in any way prior to implant? yes additional information received 07feb2024: it is noted that ¿the doctor was spinning the blue handle and the trigger wires were disassociated with the device¿.Does this mean that it was not possible to rotate the handle to stop and therefore kept turning? correct in the physician¿s opinion, were the trigger wires disassociated prior to spinning the blue handle or did it occur during the rotation? before was release troubleshooting utilized as per the ifu? yes was the physician able to land the device in the planned target zone? yes patient outcome: the patient did not experience any adverse effects due to this occurrence.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL 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 ; DA 4632
• Manufacturer Contact: alex rahbek ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 19482794
• Report Number: 3002808486-2024-00096
• Device Sequence Number: 7924487
• Product Code: MIH
• UDI-Device Identifier: 10827002353531
• UDI-Public: (01)10827002353531(17)260327(10)E4388746
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/07/2024

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: 03/27/2026
• Device Catalogue Number: ZTA-P-36-113-W
• Device Lot Number: E4388746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2023
• 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
• Patient Sex: Unknown