MAUDE Adverse Event Report: VASCUTEK LTD THORAFLEX HYBRID

Catalog Number THP3038X100B

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 04/26/2020

Event Type  Death  

Manufacturer Narrative

Manufacturers narrative clinical code: 4440 - thrombosis/thrombus: postoperative occlusion of the a.Basilaris.Impact code: 1802 - death: respiratory failure was the cause of death after paliative care.4624 - surgical intervention: the action taken as a result of the event was mechanical thrombectomy.Medical device problem.2423 - obstruction of flow: postoperative occlusion of the a.Basilaris.Component code.4755 - part/component/sub-assembly term not applicable: type of investigation.4110 - trend analysis: a 5 year review of similar complaints (occlusion/thrombosis jan 19 to feb 24) gave an occurrence rate of (b)(4)% (complaints v sales).4111 - communication/interview's: a/w additional information from the site.3331 - analysis of production record: a review of manufacturing and qc records confirmed that there were no issues with the manufacture of the device 4114 - device not returned: device remains implanted.

Event Description

As reported thor study: respiratory failure was the cause of death after paliative care after postoperative occlusion of the a.Basilaris.This thrombosis is procedure related and possibly device related (i.E.Due to the fabric properties of the luminal surface etc.).The action taken as a result of the event was mechanical thrombectomy, which did not result in clinical improvement of the patient's condition.Possibly device related - possibly procedure related.

Manufacturer Narrative

Manufacturers narrative.Clinical code: 4440 - thrombosis/thrombus: postoperative occlusion of the a.Basilaris.Impact code: 1802 - death: respiratory failure was the cause of death after paliative care.4624 - surgical intervention: the action taken as a result of the event was mechanical thrombectomy.Medical device problem.2423 - obstruction of flow: postoperative occlusion of the a.Basilaris.2993 - adverse event without identified device or use problem: scan review was performed which confirmed there is no device deficiency demonstrated and this adverse event can be classed as procedure and anatomy related.Component code 4755 - part/component/sub-assembly term not applicable: type of investigation.4110 - trend analysis: a 5 year review of similar complaints (occlusion/thrombosis (b)(6) gave an occurrence rate of (b)(4) (complaints v sales).4111 - communication/interview's: additional information was received from the site on 21 mar 24, the event occurred 2days post operation and the graft was not twisted or kinked.The graft was not occluded.Its was an occlusion of the a.Basilaris and that patient had no allergies to the graft component.No graft elongation occurred.Scan review was also performed which confirmed there is no device deficiency demonstrated and this adverse event can be classed as procedure and anatomy related.3331 - analysis of production record: full batch review was performed from raw material to finished product; no issues identified during manufacturing process.4117 - device not accessible for testing: device remains implanted.Investigation findings.213 - no device problem found: scan review was performed which confirmed there is no device deficiency demonstrated and this adverse event can be classed as procedure and anatomy related.Investigation conclusion: 4310 - cause cannot be traced to device: scan review was performed which confirmed there is no device deficiency demonstrated and this adverse event can be classed as procedure and anatomy related.50 - adverse event related to patient condition: scan review was performed which confirmed there is no device deficiency demonstrated and this adverse event can be classed as procedure and anatomy related.

Event Description

As reported thor study: respiratory failure was the cause of death after paliative care after postoperative occlusion of the a.Basilaris.This thrombosis is procedure related and possibly device related (i.E.Due to the fabric properties of the luminal surface etc.).The action taken as a result of the event was mechanical thrombectomy, which did not result in clinical improvement of the patient's condition possibly device related - possibly procedure related4.This report is being submitted as a final for manufacturing report #9612515-2024-00014 to provide event closure information for comp (b)(4).

• Brand Name: THORAFLEX HYBRID
• Type of Device: THORAFLEX HYBRID
• Manufacturer (Section D): VASCUTEK LTD; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA4 9 RR; UK PA4 9RR
• Manufacturer (Section G): VASCUTEK LTD; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA4 9 RR; UK PA4 9RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan buiness park; renfrewshire, glasgow PA4 9-RR ; UK PA4 9RR
• MDR Report Key: 18874464
• MDR Text Key: 337317477
• Report Number: 9612515-2024-00014
• Device Sequence Number: 1
• Product Code: QSK
• UDI-Device Identifier: 00503788103178
• UDI-Public: 0503788103178
• 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
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: THP3038X100B
• Device Lot Number: 17478523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2018
• 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): Death
• Patient Age: 67 YR
• Patient Sex: Male