MAUDE Adverse Event Report: VASCUTEK LTD THORAFLEX HYBRID PLEXUS GEN2 US; HYBRID STENT GRAFT, THORACIC AORTIC LESION TREATMENT

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/11/2022
Type of Reportable Event	Death
Event or Problem Description
The user facility reported that the involved wire was not removed prior to pulling the red tab causing the stent graft to accordion and lose the distal seal which led to bleeding.The device was found to be bunched up in the descending aorta.The device was pushed out and extended with a gore tag device.Patient deceased six (6) days post operation, cause of death was a stroke.

• Brand Name: THORAFLEX HYBRID PLEXUS GEN2 US
• Common Device Name: HYBRID STENT GRAFT, THORACIC AORTIC LESION TREATMENT
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan; renfrewshire, PA4 9 RR; UK PA4 9RR
• MDR Report Key: 15838735
• Report Number: 2243441-2022-00031
• Device Sequence Number: 12497775
• Product Code: QSK
• UDI-Device Identifier: 05037881026725
• UDI-Public: 05037881026725
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2022

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: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: THP3032X100A
• Device Lot Number: 22326298-4912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/10/2022
• Device Age: 6 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2022
• 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: Other; Death
• Patient Age: 47 YR
• Patient Sex: Male