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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VASCUTEK LTD.; THORAFLEX HYBRID

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VASCUTEK LTD.; THORAFLEX HYBRID Back to Search Results
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.
 
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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 Key17547650
MDR Text Key321130511
Report Number9612515-2023-00012
Device Sequence Number1
Product Code QSK
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P210006
Number of Events Reported1
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 Date10/01/2020
Device Catalogue NumberTHP2830X150
Device Lot Number17600729
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/25/2023
Initial Date FDA Received08/15/2023
Supplement Dates Manufacturer Received07/25/2023
Supplement Dates FDA Received08/29/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age75 YR
Patient SexMale
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