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

Catalog Number THP2426X100B-G

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 02/08/2020

Event Type  Injury  

Event Description

Unanticipated adverse event of carotid arteria dissection with thrombosis was reported from thor study for the patient implanted with thoraflex hybrid device.Adverse event occurred on the (b)(6) 2020.Adverse event was reported as possibly related to device, procedure, and patient's pre-existing condition.Re-operation was carried out to remove thrombus.Adverse event resolved with sequelae on (b)(6) 2020.Initially 3 events were reported (stroke, thrombus, haematoma) in fda report 9612515-2022-00016 as all three events occurred to the same patient implanted with thoraflex hybrid.However further consideration was given, and three events were split into three difeerent fda reports.Follow up report for stroke event was submitted under reference number 9612515-2022-00016.Additional report for haematoma (fda reference 9612515-2022-00023) will be submitted.

Manufacturer Narrative

(b)(4).Carotid artery dissection with thrombosis occurred on the (b)(6) 2020.Adverse event was reported as unanticipated and possibly related to device, procedure, and patient's pre-existing condition.Re-operation was carried out to remove thrombus.Adverse event resolved with sequelae on (b)(6) 2020.(b)(4).Thrombus formation event reported as possibly device related; however, device deficiency that possibly caused the event was not determined.(b)(4).Type of investigation: a 5 year review ( jan 17 - sep 22) of similar complaints (occlusion/thrombosis in thoraflex hybrid branded product) gave an occurrence rate of (b)(4) (complaints v sales) ( no negative trend was identified.Scans have been requested from the site.Device remains in situ.The review of quality, manufacturing and physical test records showed that the device was manufactured to the intended specifications.Investigation findings: no issue has been found upon review of the retained device history records for this device investigation conclusions: additional information and ct scans has been requested from the study site.

Manufacturer Narrative

Manufacturer narrative : section h6.Investigation findings : 213 - no device problem found - no issue has been found upon review of the retained device history records for this device.Further information from the site received on 15 nov 22 the site has spoken to the clinician who had confirmed that the event of thrombus is not considered to be device related.Scans were received and reviewed on 15 dec 22.The post -implant ct imaging has been performed after the re intervention to resolve the stroke.It is therefore not possible to give the conclusive review of the scans.Investigation conclusion: 67 - no problem detected - study site confirmed the event was not device related.Further action is not planned, however, the issue will be tracked and trended as part of the on-going complaints trending and reporting process and if an adverse trend develops action may be taken at that time.

Event Description

Tis report is being submitted as follow up #1 for mfg report # to provide closure information for comp (b)(4).

• Brand Name: THORAFLEX HYBRID
• Type of Device: THORAFLEX HYBRID PLEXUS
• 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 business park; glasgow, renfrewshire PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 15779720
• MDR Text Key: 303750392
• Report Number: 9612515-2022-00021
• Device Sequence Number: 1
• Product Code: QSK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P210006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: THP2426X100B-G
• Device Lot Number: 17841051
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2022
• Date Device Manufactured: 04/25/2019
• 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): Other