MAUDE Adverse Event Report: VASCUTEK LTD. THORAFLEX HYBRID

Catalog Number THP2426X100J

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/24/2024

Event Type  Injury  

Manufacturer Narrative

Manufacturers narrative.Clinical code: 4580 - insufficient information: the site confirmed on 30 jan 24; that there was no further information, images or videos are available for this event.Impact code: 4648 - insufficient information: the site confirmed on 30 jan 24; that there was no further information, images or videos are available for this event.Medical device problem: 3190 - insufficient information: the site confirmed on 30 jan 24; that there was no further information, images or videos are available for this event.Component code: 4755 - part/component/sub-assembly term not applicable.Type of investigation: 4110 - trend analysis: a similar event review was performed for leakage from factory suture events in thoraflex hybrid grafts between (b)(6) and (b)(6).A similar event rate of (b)(4)% was confirmed.No negative trend was identified.4111 - communication/ interviews: the site confirmed on 30 jan 24; that there was no further information, images or videos are available for this event 3331 - analysis of production records: full batch review was performed, and no issues were identified during manufacturing process from raw material to finished product 4114 - device not returned: device remains implanted.Investigation findings: 3221 - no findings available: the site confirmed on 30 jan 24; that there was no further information, images or videos are available for this event.Investigation conclusion: 4315 - cause not established: due to no further information being made available from the site, the root cause for this event could not be determined.

Event Description

The thoraflex was used on a patient who was brought in for an emergency aortic dissection.Although there were no problems with the graft replacement itself, blood leakage from the factory suture between the collar and the graft did not stop.Due to the leakage, weaning from cardiopulmonary bypass was not easy, and as a result, the operation was prolonged for almost one hour.The physician had been informed of the possibility of a blood leakage and that leakage would resolve after administration of protamine.However, in this case, blood leakage did not stop although act was 110.Leakage was observed over the entire circumference, giving a very poor impression of the product.Hemostasis was successfully achieved by using hydrofit.Subsequently, the procedure was completed successfully.The patient's post-operative course is favorable this report is being submitted as final to provide event closure information for (b)(4).

• Brand Name: THORAFLEX HYBRID
• Type of Device: THORAFLEX HYBRID
• Manufacturer (Section D): VASCUTEK LTD.; newmains avenue; inchinnan business park; glasgow,, renfrewshire PA4 9 RR,; UK PA4 9RR,
• Manufacturer (Section G): VASCUTEK LTD.; newmains avenue; inchinnan business park; glasgow,, renfrewshire PA4 9 RR,; UK PA4 9RR,
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan; glasgow, PA49R-R ; UK PA49RR
• MDR Report Key: 18639873
• MDR Text Key: 334535902
• Report Number: 9612515-2024-00005
• Device Sequence Number: 1
• Product Code: QSK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P210006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: THP2426X100J
• Device Lot Number: 25377476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention