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

Catalog Number THP2426X100B-G

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Hematoma (1884); Thrombosis/Thrombus (4440)

Event Date 02/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple cerebral infarctions with hemiparesis, apraxia and aphasia occurred on the (b)(6) 2020.Adverse event was reported as major and unanticipated; possibly related to device, procedure, and patient's pre-existing condition.Re-operation on carotid artery was carried out.Adverse event resolved with sequelae on (b)(6) 2020.(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).Retrosternal haematoma occurred on (b)(6) 2020.Adverse event was reported as mild and anticipated; possibly related to device, procedure, and patient's pre-existing condition.Haematoma was drained and patient received additional medication.Adverse event resolved without sequelae on (b)(6) 2020.(b)(4).All 3 events reported as possibly device related; however, device deficiency that possibly caused the events was not determined.(b)(4).The device does not have any distinct parts, components or subassemblies.

Event Description

Three events were reported from thor study for the same patient implanted with thoraflex hybrid device: first event of stroke - multiple cerebral infarctions with hemiparesis, apraxia and aphasia occurred on the (b)(6) 2020.Adverse event was reported as major and unanticipated; possibly related to device, procedure, and patient's pre-existing condition.Re-operation on carotid artery was carried out.Adverse event resolved with sequelae on (b)(6) 2020.Second event of carotid arteria 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.Third event of retrosternal haematoma occurred on (b)(6) 2020.Adverse event was reported as mild and anticipated; possibly related to device, procedure, and patient's pre-existing condition.Haematoma was drained and patient received additional medication.Adverse event resolved without sequelae on (b)(6) 2020.

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 stroke 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

This report is being submitted as follow up #2 for mfg.Report number to provide event closure information for comp (b)(4).

Manufacturer Narrative

Section h6 health effect- clinical code: 1770 - stroke - multiple cerebral infarctions with hemiparesis, apraxia and aphasia occurred on the 8 feb 2020.Adverse event was reported as major and unanticipated; possibly related to device, procedure, and patient's pre-existing condition.Re-operation on carotid artery was carried out.Adverse event resolved with sequelae on 12-23-2020.Health impact - impact code: 4641 - unexpected medical intervention - re-operation on carotid artery.Thrombus removed.Haematoma was drained.4635 - unexpected deterioration medical device problem code: 2993- adverse event without identified device or use problem - stroke event reported as possibly device related; however, device deficiency that possibly caused the event was not determined.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 5 year review (jan 17 - sep 22) of similar complaints (stroke in thoraflex hybrid branded product) gave an occurrence rate of 0.100% (complaints v sales).4110 - trend analysis - no negative trend was identified.4111 - communication / interviews - further information - scans have been requested from the site.4117 - device not available for testing - device remains in situ.3331 - analysis of production records - the review of quality, manufacturing and physical test records showed that the device was manufactured to the intended specifications.Investigation findings: 213 - no device problem found- no issue has been found upon review of the retained device history records for this device investigation conclusions: 11 - conclusion is not yet available - additional information and ct scans has been requested from the study site.

Event Description

This report is being submitted as follow up#1 for mfg.Report # 9612515-2022-00016 to provide correction to three events ((b)(4)) previously filed in one report.Major adverse event of stroke was reported from thor study for the patient implanted with thoraflex hybrid device.Event was described as follows: multiple cerebral infarctions with hemiparesis, apraxia and aphasia occurred on the (b)(6) 2020.Adverse event was reported unanticipated; possibly related to device, procedure, and patient's pre-existing condition.Re-operation on carotid artery was carried out.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 different fda reports.Additional reports for thrombus (fda reference number 9612515-2022-00021) and haematoma (fda reference 9612515-2022-00023) will be submitted.Descriptions of thrombus and haematoma events were removed from this section.

• 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; 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: 15519414
• MDR Text Key: 301014076
• Report Number: 9612515-2022-00016
• 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,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• 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