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

Model Number	G35357
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).G4) pma/510(k): p140016 summary of investigational findings: the zta-p-38-117-w (complaint device) was planned as a bridging piece in the distal thoracic aorta between custome made device (cmd) & stage1 alpha thoracic grafts.The device was advanced into intended position within the thoracic aorta.Deployed per ifu (instructions for use).When the medical doctor started to turn the black safety knob, it appeared to turn freely, but no click was noted.The blue rotation handle also turned freely, but the graft was not releasing.The medical doctor immediately released the graft, using the documented release troubleshooting ifu steps by pulling the tab, and disassembled the handle, which released the trigger wires.The stent graft was in good position, and the aortic repair continued.The patient has average calcifications and an angle in thoracic aorta, stated to be outside of the ifu.A previously implanted stage 1 graft had already been deployed thru this angle.The patient left the operating room in good condition.Per the reported information, the device was not modified in any way prior to implantation.An imaging review was performed by cri (cook research incorporated) according to the provided preoperative cta (computed tomography angiography) imaging (01jan2024) and the complaint report dated 10may2024.The impression from the imaging review is that the anatomy was unremarkable with mild tortuosity.Consequently, the imaging indicates that the anatomy was likely not a factor.As part of the device evaluation, the rotation function of the blue rotation handle was tested and no nonconformances were observed.Additionally the black safety-lock knob was turned in the direction of the arrows and a slight click was felt.No nonconformances were observed.It was not possible to determine the cause of inability to release the stent graft by turning the blue rotation handle, based on the device evaluation.Review of the device history record gave no indication of the device being produced out of specification.Based on the provided information, the imaging review and device evaluation, the exact cause for this event, cannot be determined.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: alpha graft advanced into intended position within the thoracic aorta.Deployed per instructions for use (ifu).When the physician started to turn the black safety, knob it appeared to turn freely.The blue rotation handle also turned freely and the graft was not releasing.The physician immediately released the graft using the documented release troubleshooting ifu steps pulled tab, and disassembled the handle, which released the trigger wires.The delivery system was saved for inspection.Patient outcome: graft was in good position, and the aortic repair continued.Patient left the operating room in good condition.

• 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: 20841227
• Report Number: 3002808486-2024-00255
• Device Sequence Number: 20843094
• Product Code: MIH
• UDI-Device Identifier: 10827002353579
• UDI-Public: (01)10827002353579(17)260329(10)E4389624
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2024

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: 03/29/2026
• Device Model Number: G35357
• Device Catalogue Number: ZTA-P-38-117-W
• Device Lot Number: E4389624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2023
• 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: Male