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 2020-01-24 for VENA SEAL CLOSURE SYSTEM VS-402 manufactured by Medtronic Ireland.

Event Text Entries

[176232646] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[176232647] The patient had their great saphenous vein (gsv) and short saphenous vein (ssv) treated with vena seal. Procedure was carried out over 4 days as per ifu. Post-procedure a skin irritation was reported on the patient? S back and neck. The patient was treated with a medrol dose pack, topical steroid, antihistamines. It was reported that the irritation is still present.
Patient Sequence No: 1, Text Type: D, B5


[182472330] Additional information: the first vessel treated was the right anterior accessory great saphenous vein. The following day the left great anterior left saphenous vein was treated. The left great saphenous vein was treated 5 days later and the right great saphenous vein was treated one week after the first venaseal implant. The symptoms appeared on the day of the last procedure. The patient condition has resolved after treatment. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[182473914] Image review: seven photographic images were received for evaluation. The images are of red rash on the patient? S upper front thighs, upper arms, and obliques. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[188465556] Product analysis #(b)(6):-10 seven photographic images were received for evaluation. The first four images are of the consent form dated 01-07-2020 and include the venaseal peel-off label of lot 56818. The fifth, sixth, and seventh images are from a later date. The images are of red rash on the patient? S upper front thighs, upper arms, and obliques. Technical analysis of the received photographic images confirm the reported event of redness and rash over portions of the patient. 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 Number9612164-2020-00401
MDR Report Key9626959
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-01-24
Date of Report2020-03-06
Date of Event2020-01-14
Date Mfgr Received2020-03-05
Device Manufacturer Date2019-08-26
Date Added to Maude2020-01-24
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 Received2020-01-24
Catalog NumberVS-402
Lot Number56818
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. Required No Informationntervention 2020-01-24

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