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	Diminished Pulse Pressure (2606)
Date of Event	03/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the doctor inserted the involved thorflex hybrid plexus device into the patient at the conclusion of the procedure he said that the tee study of the stent looked open and patent.The brachial pressures matched the femoral pressures as well.The doctor also stated that he did well and was progressing in his recovery over the weekend.However, either sunday or monday night y his brachial pressures did not match the femoral and his health started to decline.A ct scan was done at that time and showed compression of the stent graft portion of the thoraflex.There is a follow up procedure scheduled for 15 mar 2023 to address the stent compression.Additional information was received on relevant medical conditions.Type a and type b dissection with previous ascending hemiarch repair and a thoraco abdominal graft.Physician's opinion for cause of this event was possibility the device not the procedure and pre-existing condition, yes.Patient outcome was patient was in the hospital and intubated.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 to correct the date in section f6.

• 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: 16722372
• Report Number: 2243441-2023-00017
• Device Sequence Number: 7209436
• Product Code: QSK
• UDI-Device Identifier: 05037881026824
• UDI-Public: 05037881026824
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2023
• Report Date (Section F): 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: 07/31/2024
• Device Model Number: N/A
• Device Catalogue Number: THP3032X150A
• Device Lot Number: 25015713-5098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/16/2023
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 04/20/2023
• 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
• Patient Age: 43 YR
• Patient Sex: Male