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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VASCUTEK LTD THORAFLEX HYBRID PLEXUS GEN2 US; HYBRID STENT GRAFT, THORACIC AORTIC LESION TREATMENT
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VASCUTEK LTD THORAFLEX HYBRID PLEXUS GEN2 US; HYBRID STENT GRAFT, THORACIC AORTIC LESION TREATMENT Back to Search Results
Model Number N/A
Device Problem Material Deformation (2976)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 10/11/2022
Event Type  Death  
Event Description
The user facility reported that the involved wire was not removed prior to pulling the red tab causing the stent graft to accordion and lose the distal seal which led to bleeding.The device was found to be bunched up in the descending aorta.The device was pushed out and extended with a gore tag device.Patient deceased six (6) days post operation, cause of death was a stroke.
 
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Brand Name
THORAFLEX HYBRID PLEXUS GEN2 US
Type of Device
HYBRID STENT GRAFT, THORACIC AORTIC LESION TREATMENT
Manufacturer (Section D)
VASCUTEK LTD
newmains avenue
inchinnan
renfrewshire, PA4 9 RR
UK  PA4 9RR
MDR Report Key15838735
MDR Text Key304078972
Report Number2243441-2022-00031
Device Sequence Number1
Product Code QSK
UDI-Device Identifier05037881026725
UDI-Public05037881026725
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 11/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2024
Device Model NumberN/A
Device Catalogue NumberTHP3032X100A
Device Lot Number22326298-4912
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date11/10/2022
Device Age6 MO
Event Location Hospital
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Death;
Patient Age47 YR
Patient SexMale
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