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,distri report with the FDA on 2020-02-10 for ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM 24653 manufactured by Boston Scientific Corporation.

Event Text Entries

[179486038] (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[179486039] It was reported that the device became entrapped on the guidewire and the stent partially deployed. The 99% stenosed target lesion was located in the superficial femoral artery (sfa). Pre-dilation was performed. A 7x120, 130cm eluvia drug-eluting vascular stent system was selected for use. While deploying the stent, the guidewire became stuck in the system and deployment became difficult. Strong force was required to turn the thumbwheel and the stent was placed in the blood vessel for more than 2/3 of its length. The system was then forcibly pulled and the entire length of the stent was placed. The proximal part of the stent was placed in a slightly stretched state, and the procedure was completed. The effect of a kink in the shaft was noted in the iliac bifurcation part during contralateral approach. No patient complications were reported and the patient's status is stable.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-01168
MDR Report Key9687572
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-02-10
Date of Report2020-03-02
Date of Event2020-01-24
Date Mfgr Received2020-02-21
Device Manufacturer Date2019-08-29
Date Added to Maude2020-02-10
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 Received2020-02-10
Returned To Mfg2020-02-07
Model Number24653
Catalog Number24653
Lot Number0024502793
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressTWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-10

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