ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM 24653

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-24 for ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM 24653 manufactured by Boston Scientific Corporation.

Event Text Entries

[184737879] (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[184737880] It was reported that in-stent restenosis occurred. The subject was enrolled in the (b)(6) study on (b)(6) 2019 and the index procedure was performed on the same day. The target lesion was located in right distal superficial femoral artery (sfa) involving the popliteal artery with 100% stenosis and was 140 mm long with a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm. It was classified as tasc ii b lesion. The target lesion was treated with pre-dilatation followed by direct placement of 7 mm x 100 mm and 7 mm x 80 mm study stent. Following post dilation, residual stenosis was 0%. On (b)(6) 2019, the subject was discharged with antiplatelet therapy. On (b)(6) 2020, the subject was diagnosed with in-stent occlusion at the right distal sfa. On same day subject was hospitalized for further treatment and evaluation. There was 100% stenosis, which was 140 mm long with a reference vessel diameter of 5 mm. Thrombolysis treatment was performed. Post revascularization, the residual stenosis was 15%. On (b)(6) 2020, the event was considered recovered and resolved with sequelae and the subject was discharged on the same day.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-03761
MDR Report Key9872581
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-24
Date of Report2020-03-24
Date of Event2020-01-28
Date Mfgr Received2020-03-04
Device Manufacturer Date2017-07-21
Date Added to Maude2020-03-24
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 ContactJAY JOHNSON
Manufacturer StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal55311
Manufacturer Phone7634942574
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer StreetBALLYBRIT BUSINESS PARK
Manufacturer CityGALWAY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
Product CodeNIU
Date Received2020-03-24
Model Number24653
Catalog Number24653
Lot Number0020986452
Device Expiration Date2019-01-17
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressTWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-24

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