MAUDE Adverse Event Report: VASCUTEK LTD.; THORAFLEX HYBRID

Catalog Number THP2830X150

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 04/25/2020

Event Type  Death  

Event Description

As reported thor event study team has been informed patient died (b)(6) 2020.No autopsy done.Further information has been requested, will update sae crf once available.Cause of death is unknown.No source available, ""possibly related"" entered as definitive assessment cannot be performed.*text above stating (b)(6) , event date in crf (b)(6) 2020".

Manufacturer Narrative

Clinical code: 4580 insufficient information: additional information has been requested from site.Impact code 1802 death: patient outcome was death, reason for this is still unknown 4648 insufficient information: additional information has been requested from site.Medical device problem code 3190 insufficient information: additional information has been requested from site.Type of investigation 4110 trend analysis: a similar event review was performed for this event which gave an occurrence rate of 0.079%.No negative trend identified 3331 analysis of production record: a review of the batch records confirm that device was manufactured to specification.4119 insufficient information: additional information has been requested from site.

Event Description

As reported thor event.Study team has been informed patient died in (b)(6) 2020.No autopsy done.Further information has been requested, will update sae crf once available.Cause of death is unknown.No source available, ""possibly related"" entered as definitive assessment cannot be performed.*text above stating may, event date in crf 25-apr-2020" this report is being submitted as final report for mfg.Report to provide event closure information for comp (b)(4).

Manufacturer Narrative

Section b5 updated with additional information.Clinical code: 4580 insufficient information: the patient was pronounced deceased on arrival to hospital, and an autopsy was not performed.Impact code: 1802 death: patient outcome was death, reason for this is still unknown 4648 insufficient information: the patient was pronounced deceased on arrival to hospital, and an autopsy was not performed.Medical device problem code: 3190 insufficient information: the patient was pronounced deceased on arrival to hospital, and an autopsy was not performed.There is no direct allegation against the device, but again, there's no information available for/against device relationship.Type of investigation: 4110 trend analysis: a similar event review was performed for this event which gave an occurrence rate of 0.079%.No negative trend identified.3331 analysis of production record: a review of the batch records confirm that device was manufactured to specification.4119 insufficient information: the patient was pronounced deceased on arrival to hospital, and an autopsy was not performed.Investigation findings: 3221 no findings available: no autopsy was done, and we therefore do not have any samples available.Investigation conclusion: 4315 cause not established: no root cause identified for this event due to a lack of information.There is no direct allegation against the device, but again, there's no information available for/against device relationship.Component code: 4755 part/component/sub-assembly term not applicable.

• 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; glasgow, PA49R R; UK PA49RR
• Manufacturer Contact: jason whittle ; newmains avenue; inchinnan; glasgow, PA49R-R ; UK PA49RR
• MDR Report Key: 17547650
• MDR Text Key: 321130511
• Report Number: 9612515-2023-00012
• Device Sequence Number: 1
• Product Code: QSK
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Catalogue Number: THP2830X150
• Device Lot Number: 17600729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2018
• 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: 75 YR
• Patient Sex: Male