MAUDE Adverse Event Report: VASCUTEK LTD THORAFLEX HYBRID

Catalog Number	THA3034X100A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/02/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Manufacture's narrative clinical code 4581 - appropriate clinical signs, symptoms, conditions term / code not available: patient died on (b)(6) 2023.Impact code 1802 death - patient died on (b)(6) 2023.Medical device problem 3190 insufficient information - a/w additional information from site.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 > artery) gave an occurrence rate of 0.043% (complaints v sales).4111 communication/ interviews - a/w additional information from site 3331 analysis of production records - 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 or Problem Description
As reported extend study: automated e-mail notification received from study database on 23 jan 24 reporting the event aortic thrombus from (b)(6) 2023.No additional description was provided.The site recorded that this was related to the thoraflex hybrid device and email correspondence indicates the device itself had no deficiencies, and there was no misplacement or maldeployment.
Additional Manufacturer Narrative
Manufacture's narrative: clinical code 4581 - appropriate clinical signs, symptoms, conditions term / code not available: patient died on (b)(6) 2023.4440 - thrombosis/ thrombus: this event was reported as aortic thrombus on (b)(6) 2024.Impact code: 1802 death - patient died on (b)(6) 2023.Medical device problem: 2993 - adverse event without identified device or use problem: site reported this event as aortic thormbus.From the investigation performed and scan review a root cause for this event could not be determined.No causal link between the event and device deficiency could be established.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 > artery) gave an occurrence rate of 0.043% (complaints v sales).4111 communication/ interviews - additional information was received from site; unfortunately without the return of the device we could not complete a full investigation.From the investigation performed and scan review a root cause for this event could not be determined.No causal link between the event and device deficiency could be established.3331 analysis of production records - full batch review was performed, no issue were identified from raw material to finished product.4117 device not accessible for testing - device remains implanted.Investigation findings: 213 - no device problem found : from the investigation performed and scan review a root cause for this event could not be determined.No causal link between the event and device deficiency could be established.Investigation conclusion: 67 - no problem detected: from the investigation performed and scan review a root cause for this event could not be determined.No causal link between the event and device deficiency could be established.
Event or Problem Description
As reported extend study: automated e-mail notification received from study database on 23 jan 24 reporting the event aortic thrombus from (b)(6) 2023.No additional description was provided.The site recorded that this was related to the thoraflex hybrid device and email correspondence indicates the device itself had nodeficiencies, and there was no misplacement or maldeployment this report is being submitted as a final for manufacturing report #9612515-2024-0009 to provide event closure information for (b)(4).

• Brand Name: THORAFLEX HYBRID
• Common Device Name: 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; nchinnan buiness park; renfrewshire, glasgow PA4 (-RR ; UK PA4 (RR
• MDR Report Key: 18736770
• Report Number: 9612515-2024-00009
• Device Sequence Number: 15264540
• Product Code: QSK
• UDI-Device Identifier: 05037881026947
• UDI-Public: 05037881026947
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P210006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Remedial Action: Repair,Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: THA3034X100A
• Device Lot Number: 25168257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male