VENA SEAL CLOSURE SYSTEM VS-402

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-02 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.

Event Text Entries

[173704631] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[173704632] Patient had entire great saphenous vein (gsv) treated with venaseal during a late afternoon procedure. No images were recorded during the procedure. The procedure was completed as per ifu. 2 days later the patient presented at the hospital and had a venous ultrasound which did not show any dvt. 30 minutes post ultrasound the patient had a computed tomography angiography (cta) scan which showed a pe. The scan revealed moderate acute bilateral pulmonary emboli with evidence of mild right heart strain. No further information reported.
Patient Sequence No: 1, Text Type: D, B5


[188281107] Additional information: patient had essentially normal exam except venous insufficiency findings. Patient had no cardiovascular or pulmonary history prior to this event. Patient was hospitalized and treated with iv heparin followed by eliquis on discharge. All venous ultrasounds done showed no thrombus in superficial or deep veins. Patient status is improved. Patient will be referred to haematology regarding possible hypercoagulable state. No further patient injury was reported for this event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9612164-2020-00015
MDR Report Key9537592
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-01-02
Date of Report2020-01-08
Date of Event2019-12-20
Date Mfgr Received2020-01-07
Device Manufacturer Date2018-12-19
Date Added to Maude2020-01-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactTONI O'DOHERTY
Manufacturer StreetPARKMORE BUSINESS PARK WEST
Manufacturer CityGALWAY
Manufacturer Phone091708734
Manufacturer G1MEDTRONIC IRELAND
Manufacturer StreetPARKMORE BUSINESS PARK WEST
Manufacturer CityGALWAY
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVENA SEAL CLOSURE SYSTEM
Generic NameAGENT, OCCLUDING, VASCULAR, PERMANENT
Product CodePJQ
Date Received2020-01-02
Catalog NumberVS-402
Lot Number53940
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC IRELAND
Manufacturer AddressPARKMORE BUSINESS PARK WEST GALWAY


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-01-02

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