MAUDE Adverse Event Report: VASCUTEK LTD THORAFLEW HYBRID; HYBRID STENT GRAFT, THORACIC AORTIC LESION TREATMENT

Catalog Number THP3032X150B

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Event reported as stent fracture in thoraflex hybrid.Device was implanted on (b)(6) 2022 same day chest x-ray was normal.3 days post op ct performed but device failure not picked up.Stent fracture was noticed on the (b)(6) 2022 when re intervention was taking place to extend distally with tevar stents.No injury or issues caused to patient's health.Re-intervention was not due to the stent fracture.

Event Description

Event reported as stent fracture in thoraflex hybrid.Device was implanted on (b)(6) 2022.Same day chest x-ray was normal.3 days post op ct performed but device failure not picked up.Stent fracture was noticed on the (b)(6) 2022 when re intervention was taking place to extend distally with tevar stents.No injury or issues caused to patient's health.Re-intervention was not due to the stent fracture this report has been submitted as final report for mfg.Report fda 9612515-2022-00024 comp (b)(4) final.

Manufacturer Narrative

Health effect- clinical code: 4582 - no clinical symptoms - the fracture of the ring stent was noticed during reintervention on 15 sep 22 to extend the hybrid device with tevar stents.Health impact - impact code: 2199 - no health impact was reported- no injury or issue to patient, device still in situ.Medical device problem code : 1260 - event reported as stent fracture in thoraflex hybrid.Device was implanted on (b)(6) 2022.Same day chest x-ray was normal.3 days post op ct performed but device failure not picked up.Stent fracture was noticed on the (b)(6) 2022 when re intervention was taking place to extend distally with tevar stents.No injury or issues caused to patient's health.Re-intervention was not due to the stent fracture.Component code: 4755- part/ component / sub-assembly term not applicable - the device does not have any distinct parts, components or subassemblies.Type of investigation: 4109 - historical data analysis - a five year review of similar reported events of ring stent fracture relating to thoraflex hybrid product was completed, an occurrence rate of (b)(4) was confirmed.4110 - trend analysis - no negative trend was identified.This is the first occurrence of ring stent fracture in thoraflex product.4111 - communication / interviews - further information obtained from site.4117 - device not available for testing - device remains in situ.3331 - analysis of production records - qc, manufacturing records were retrieved and reviewed and show that the device was manufactured to design specification.4105 - testing of raw/starting materials - testing performed on another device with nitinol wire from the same batch has shown the wire had no defects and performing within specification.Investigation findings: 4247 - appropriate term/code not available - from the information provided and the analysis carried out on the scans, the most likely root cause is deemed to be a high oversize selection, outside the guidelines in the ifu, along with the tilted position of the distal ring, which is not normally an issue but may have been compounded by the high oversize.It is however not possible to determine whether a high oversize was relevant in this case as no information around the oversize selection was provided.Investigation conclusion: 4315 - cause not established - device showed ring stent fracture on (b)(6) 2022 , no injury or issue to patient, device still in situ.Distal extension completed with tevar.

• Brand Name: THORAFLEW HYBRID
• Type of Device: HYBRID STENT GRAFT, THORACIC AORTIC LESION TREATMENT
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, PA49R R; UK PA49RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan; glasgow, PA49R R; UK PA49RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan; glasgow, PA49R-R ; UK PA49RR
• MDR Report Key: 15903853
• MDR Text Key: 308109163
• Report Number: 9612515-2022-00024
• Device Sequence Number: 1
• Product Code: QSK
• Combination Product (y/n): N
• PMA/PMN Number: P21006
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: THP3032X150B
• Device Lot Number: 22034676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention