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

Model Number	G38172
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Occupation: operating room manager.Investigation is still in progress.
Event or Problem Description
According to initial reporter.The trigger wires did not release upon turning the handle ((b)(4)).They disassembled the handle to manually release the trigger wires and the trigger wires did release enabling the graft to deploy.Then, upon removing the delivery system, the dilator tip separated ((b)(4)).It was already enough out of the patient that they were able to manually remove the dilator tip.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient did not require any additional procedures due to this occurrence.
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 80 year-old male patient with a suprarenal abdominal aortic aneurysm underwent a thoracic endovascular aortic repair (tevar) with a zta-pt-34-30-161-w (complaint device) it was reported per phone that the trigger wires did not release upon turning the handle (b)(4).They disassembled the handle to manually release the trigger wires and the trigger wires did release enabling the graft to deploy.Then, upon removing the delivery system, the dilator tip separated (b)(4).It was already enough out of the patient that they were able to manually remove the dilator tip.It was reported that there was no harm to patient.The device was returned and the product evaluation concluded that : it has not been possible to determine a cause for the reported failure.It is unknown whether the friction between the cannula tube and the cannula hub, and the flakes observed could indicate presence of adhesive material.It is not possible to confirm nor unconfirm the presence of adhesive material.Per ifu: if the blue rotation handle stops before completing the rotation (so that the proximal end of the graft is not released from the introduction system), verify the position of the black safety-lock knob and, if necessary, turn it counterclockwise to the unlocked position.If the black safety-lock knob is removed from the system after it has been turned counterclockwise to the unlocked position, the blue rotation handle will remain engaged.Continue with the procedure.Note: if it is still difficult to rotate the blue rotation handle, refer to release troubleshooting for instructions on how to disassemble the blue rotation handle.Review of the device history record gave no indication of the device being produced out of specification.Based on the provided information it has not been possible to establish the cause of the reported event.However user error may have contributed to the event.Futhermore the physician created 4 fenestrations on the alpha device to fit the patient's anatomy which also could have contributed to troubles with releasing the trigger wires.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 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, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov ; 56868686
• MDR Report Key: 12280278
• Report Number: 3002808486-2021-01679
• Device Sequence Number: 3531713
• Product Code: MIH
• UDI-Device Identifier: 10827002381725
• UDI-Public: (01)10827002381725(17)240614(10)E4122179
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P140016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2022

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: 06/14/2024
• Device Model Number: G38172
• Device Catalogue Number: ZTA-PT-34-30-161-W
• Device Lot Number: E4122179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2021
• 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 Age: 80 YR
• Patient Sex: Male