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 2020-01-15 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.

Event Text Entries

[175027103] Image review: (physician notes and photo of leg): the physician notes describe two separate patient visits with led to the approval from treatment. The notes indicate symptomatic varicose veins have been identified. The notes did not specifically indicate the varicose veins would be treated using venaseal. Final physician note indicating ablation: "plan: varicose veins of right lower extremity with pain continue aspir-81, notes: right gsv reflux. Schedule ablation. The provided photo shows a leg with necrosis at the suspected access site and proximal from access site which was identified during post procedure follow up according to the customer. Redness around the identified areas of necrosis was identified. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[175027104] Patient was treated with venaseal great saphenous vein (gsv) was treated. The vein is reported to have closed. Patient returned for follow-up appointment 5 days post implant and underwent a venous ultrasound which showed a dilated and refluxing left gsv. Patient continues to have left lower extremity aching, burning and cramping with varicosities despite conservative therapy including compression therapy, leg elevation and avoidance of prolonged sitting and standing over a period of 3 months with only partial relief reported. Patient cannot stand during the day without having to sit and elevate legs. It has been reported a reaction occurred post procedure resulting in necrosis at the access site and proximal from access site which was identified during post procedure follow up. Patient had been hospitalised for another condition. This resulted in partial explant of the cyanoacrylate at the access site and at the proximal from the access site. The patient is now reported to have open wounds at the mid and lower leg from the partial explant. Patient has been referred to a wound care centre for treatment. No further patient injuries reported
Patient Sequence No: 1, Text Type: D, B5


[188422187] Additional information: necrosis at the access site was noticed by the physician a few days after the procedure. Access site was an open wound above the ankle. Physician note and image review: the physician notes describe two separate patient visits which led to the approval for treatment. The notes indicate symptomatic varicose veins have been identified. The provided photo shows a leg with necrosis at the suspected access site and proximal from access site which was identified during post procedure follow up according to the customer. Redness around the identified areas of necrosis was identified. Correction: patient age updated. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[188422365] 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 Number9612164-2020-00236
MDR Report Key9590515
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-01-15
Date of Report2020-02-20
Date of Event2019-08-27
Date Mfgr Received2020-02-14
Date Added to Maude2020-01-15
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 Received2020-01-15
Catalog NumberVS-402
Lot NumberUNK
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 2020-01-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.