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

Model Number	G38191
Medical Device Problem Codes	Mechanical Jam (2983); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Pma/510(k): p140016.(b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to initial reporter: a 74 year old female patient underwent a tvar procedure in which the zenith alpha throacic endovascular graft proximal tapered components, g38191, was used.The proform wire did not detach from implant.The district manager and surgeon broke apart the handle to manually release the wire and graft.The graft had pulled back from intended spot of deployment as the physician had thought the graft had detached from the delivery system.At this time there is no follow up procedure being scheduled to place a graft in the area above the implanted graft, however, the surgeon stated at some point in the future another procedure will need to be done.
Event or Problem Description
Additional information (b)(6) 2022: patient anatomy was normal in area of difficulty.The sequence on how the trigger wires were released: surgeon rotated handle on alpha device after deployed to release trigger wires.Handle stopped rotating but wires did not fully release from the proform suture because device pulled back when trying to take dilator out.If it was released it wouldn¿t be attached to delivery system anymore.Stopped pulling dilator and removed wires manually by removing handle.Graft probably came back a little less than 1cm from where it was originally.
Additional Manufacturer Narrative
Manufacturer ref#(b)(4).Investigation is still in progress.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.
Additional Manufacturer Narrative
Manufacturer ref#(b)(4).Summary of investigational findings: a 74-year-old female patient underwent tevar (thoracic endovascular aortic repair) in which a zta-pt-40-36-167-w (complaint device) was used.The steel wire did not detach from implant despite the rotation handle has been rotated to stop.The district manager and surgeon broke apart the handle to manually release the wire and graft.The graft had pulled back from intended spot of deployment approximately 1 cm as the physician had thought the graft had detached from the delivery system.At this time there is no follow up procedure being scheduled to place a graft in the area above the implanted graft, however, the surgeon stated at some point in the future another procedure will need to be done.No device was returned, and no imaging was provided.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 determine the 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 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: 14674165
• Report Number: 3002808486-2022-00818
• Device Sequence Number: 14837318
• Product Code: MIH
• UDI-Device Identifier: 10827002381916
• UDI-Public: (01)10827002381916(17)240528(10)E4114241
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2022

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: 05/28/2024
• Device Model Number: G38191
• Device Catalogue Number: ZTA-PT-40-36-167-W
• Device Lot Number: E4114241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 07/02/2022; 11/25/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 07/18/2022; 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2021
• 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: 74 YR
• Patient Sex: Female