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 2020-03-09 for ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM 24653 manufactured by Boston Scientific Corporation.

Event Text Entries

[182597064] It was reported that the stent partially deployed. Approach from the humeral was used to access the 70% stenosed target lesion. The lesion was pre-dilated. A 6x120x130 eluvia self-expanding stent was advanced over a 0. 035 starter guidewire inside a 6f sheath. During the procedure, the physician began to deploy the stent without difficulty for the first five centimeters. The thumbwheel continued to be rotated, but the stent no longer deployed. An unsuccessful attempt to use the pull grip was made. The eluvia device was removed with the stent partially deployed. The procedure was completed with a coated balloon without stenting and there were no patient complications.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-02771
MDR Report Key9805608
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-09
Date of Report2020-03-09
Date of Event2020-02-24
Date Mfgr Received2020-02-25
Device Manufacturer Date2019-07-11
Date Added to Maude2020-03-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 IRELAND LIMITED
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 Received2020-03-09
Model Number24653
Catalog Number24653
Lot Number0024198339
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
10 2020-03-09

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