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

Model Number	G47456
Medical Device Problem Codes	Difficult to Remove (1528); Malposition of Device (2616)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
As reported "the green trigger wire mechanism was unable to be removed from the delivery system following deployment.This prevented the physician from being able to remove the delivery system and required the team to take manual action to access and remove the trigger wires in order to remove the delivery system.The physician needed to cut the grey inner cannula in order to access and manually remove the individual trigger wires.This intervention was effective but induced blood loss through the delivery system.While attempting to remove the green trigger wire from the tx2 delivery system, the graft was inadvertently repositioned several millimeters resulting in an inadequate proximal landing.As a result, an additional zdeg stent graft was required to achieve the intended proximal landing position.The deployment system was secured in a bio-hazard bag and it currently being held at the hospital facility.".

• 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
• MDR Report Key: 10080239
• Report Number: 3005580113-2020-00367
• Device Sequence Number: 14406889
• Product Code: MIH
• UDI-Device Identifier: 10827002474564
• UDI-Public: (01)10827002474564(17)230302(10)E3957665
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2020
• Report Date (Section F): 05/21/2020

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: 03/02/2023
• Device Model Number: G47456
• Device Catalogue Number: ZDEG-P-36-79-PF-US
• Device Lot Number: E3957665
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/13/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/21/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR