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

Model Number	G38178
Medical Device Problem Codes	Failure to Auto Stop (2938); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Pma/510(k): p140016.Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: a tevar was completed (b)(6) 2022 in which the alpha device handle made no clicking noise nor did it come to a complete stop indicating full deployment.It was noted on flouro it appeared to have deployed.We then magnified the view during slow removal of the dilator and cannula.There was no issue in the removal, but it caused concern of the physician.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).After investigation the event for this pr# is no longer reportable.Summary of investigational findings: a zta-pt-36-32-161-w was to be placed in the arch at the distal edge of left carotid.It was reported that the device handle did not make a clicking sound and no stop was felt to indicate full deployment.Flouroscopy showed that the device appeared to be fully deployed.Zta-pt-36-32-161-w device was returned without shipping stylet, peel aways, black safety lock knob and stent graft.Evaluation of the device showed that the rotation handle was returned rotated to stop.No damages or abnormal findings were observed on the rotation handle, sliding rod or threaded wire knob.Review of the device master record revealed no requirements for the releasing mechanism to have a sound or a click.Review of the device history record gave no indication of the device being produced outside of specifications.The ifu sent with the device states: 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 where the click sound from the blue rotation handle is referred to as being an indicator for the release mechanism.Based on the reported information and evaluation of the returned device this complaint is unconfirmed as the clicking sound is not a requirement and the handle on the returned device was turned to stop.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
• MDR Report Key: 13256970
• Report Number: 3002808486-2022-00020
• Device Sequence Number: 4726374
• Product Code: MIH
• UDI-Device Identifier: 10827002381787
• UDI-Public: (01)10827002381787(17)240525(10)E4112391
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2022

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: 05/25/2024
• Device Model Number: G38178
• Device Catalogue Number: ZTA-PT-36-32-161-W
• Device Lot Number: E4112391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2021
• 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 Sex: Unknown