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

Model Number	G35373
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
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
According to the initial reporter.Upon deploying the device, after it was unsheathed, they went to rotate the handle.Under fluoro, while rotating, it appeared the device was pulling into itself (trigger wires going in the opposite direction).At that point, they took apart the handle and manually removed the trigger wires, ultimately releasing the graft from the delivery system.Device was successfully implanted/deployed in the correct location.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.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).After investigation the event for this complaint is no longer reportable.Summary of investigational findings: a patient with a thoracic aneurysm underwent thoracic endovascular repair (tevar), where a zta-pt-36-32-161-w, a zta-p-173-w, a zta-pt-46-42-179-w and a zta-p-46-125-w (complaint device) were used.The patient anatomy was not reported to be tortuous or with calcification.After the device has been unsheathed, upon the deployment during the rotation of the of the blue rotation handle, the physician experienced the proximal bare stent was being pulled into the first covered stent.It was reported that the blue rotation handle was harder than usual.The physician has performed troubleshooting by disassembling the blue rotation handle and pulling the release wires manually until the graft was released.The patient did not experience any adverse effects to this occurrence.Review of the device history record gave no indication of the device being produced out of specification.Based on the provided information and review of documentation it has not been possible to determine an exact cause of the reported event.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 COMPONENTS
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 12030818
• Report Number: 3002808486-2021-01355
• Device Sequence Number: 3412060
• Product Code: MIH
• UDI-Device Identifier: 10827002353739
• UDI-Public: (01)10827002353739(17)221104(10)E3916314
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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: 11/04/2022
• Device Model Number: G35373
• Device Catalogue Number: ZTA-P-46-125-W
• Device Lot Number: E3916314
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1