MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G47440
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Description of event according to initial reporter: patient came in for a dissection emergent case.During deployment or user aggression the graft landed distal to where the actual approx landing zone wanted to be ((b)(4)).The physician decided to use a device from another manufacturer to get more of a proximal seal.Delivered the device then distality he extended out the zdes-36-180-us.Upon final run he was satisfied with the final angio.Fast forward to recently within the last week the patient had to come back in with a type a dissection to where they had to build the arch ((b)(4)).Patient outcome: the patient was prolonged hospitalized for recovery.Furthermore, the patient had to return for complete arch repair.
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Pma/510(k): p180001.Investigation is still in progress.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.
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Summary of investigational findings: a female patient came in with an emergent case of a ruptured type b dissection.The deployment of the zdeg-p-26-136-pf-us (complaint device) was rushed caused by the emergent case and the device was not landed in the intended zone (left subclavian artery).A device from another manufacturer was placed proximally to complaint device to ensure proximal seal and a zdes-36-180-us was placed distally to complaint device.After unknown amount of time, the patient was admitted with a type a dissection and had complete arch repair performed.Physician did not suspect the devices caused a type a dissection.Patient had follow-up on (b)(6) 2023 and left that hospital against medical advice.No imaging was provided and no device was returned.No evidence to suggest that the product was not manufactured according to specifications.Per instructions for use, constantly monitoring of graft position should be performed as well as using angiography to check the graft position.Based on provided information and physician testimony, the misplacement is likely caused by rushed deployment as the patient had ruptured dissection.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
Additional information received 17feb2023: it was operator error.The physician rushed the deployment.
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Investigation is still in progress.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
Additional information received 07feb2023: the patient came in as a rupture.Intended landing zone was at left subclavian artery, physician did not land at intended landing zone, so he extended with a competitor graft.Graft did not migrate.Physician did not land at intended landing site.

• Brand Name: ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT
• 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: 16085023
• Report Number: 3002808486-2023-00001
• Device Sequence Number: 2009952
• Product Code: MIH
• UDI-Device Identifier: 10827002474403
• UDI-Public: (01)10827002474403(17)250214(10)E4221147
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/14/2025
• Device Model Number: G47440
• Device Catalogue Number: ZDEG-P-26-136-PF-US
• Device Lot Number: E4221147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2022
• Supplement Date Received by Manufacturer: 02/07/2023; 02/17/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 02/23/2023; 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female