MAUDE Adverse Event Report: VASCUTEK LTD. THORAFLEX HYBRID; THORAFLEX HYBRID PLEXUS

Model Number	THP3032X100A
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	10/11/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).Type of investigation historical data analysis - a 5-year similar events review was carried out for death events in patients implanted with thoraflex hybrid.The low occurrence rate of 0.094% was confirmed (complaints v sales).Trend analysis - no negative trend in number of death reported events was identified.Analysis of production records - a review of the retained manufacturing and quality control records confirmed that the device was manufactured to the intended specifications.Device not returned to manufacturer.Investigation findings no device problem found.Investigation conclusion failure to follow instructions - physician did not remove wire prior to pulling red tab.That goes against product ifu guidance.Thoraflex hybrid us ifu(31-213-usen) section 12.5.3 guide wire removal consists of caution that states the following: if a guide wire was used during deployment of the device, it must be removed from the system before the release wire is removed.This step enables the guide wire to be removed while device remains held in position by the system, thereby preventing movement of the stented section.
Event or Problem Description
On the (b)(6) 2022 thoraflex hybrid implant was carried out.During procedure wire was not removed prior to pulling red tab causing stent graft to "accordion" and loss of distal seal leading to bleeding.Stented section of the device was found to be bunched up in the descending aorta.Device pushed out and extended with gore tag device.Six days post procedure patient deceased due to stroke.

• Brand Name: THORAFLEX HYBRID
• Common Device Name: THORAFLEX HYBRID PLEXUS
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD.; newmains avenue; inchinnan business park; renfrewshire PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan business park; renfrewshire PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 15779818
• Report Number: 9612515-2022-00020
• Device Sequence Number: 5127140
• Product Code: QSK
• UDI-Device Identifier: 05037881026725
• UDI-Public: 05037881026725
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P210006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2022

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: THP3032X100A
• Device Catalogue Number: THP3032X100A-G
• Device Lot Number: 22326298
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 47 YR
• Patient Sex: Male