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 2020-03-29 for ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM 24653 manufactured by Boston Scientific Corporation.

Event Text Entries

[185664054] Device is combination product. (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[185664055] It was reported that the shaft was separated. A 6x80, 130 cm eluvia drug-eluting vascular stent system was selected for use. The device was unable to cross the lesion. After the device was removed outside the body, it was observed that the outer shaft covering the stent was separated from the tip of the shaft. The handle had already been rotated approximately one to two times. The procedure was completed with a different device. There were no patient complications reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-04041
MDR Report Key9896149
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-03-29
Date of Report2020-03-29
Date of Event2020-03-10
Date Mfgr Received2020-03-11
Device Manufacturer Date2019-03-07
Date Added to Maude2020-03-29
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 Received2020-03-29
Returned To Mfg2020-03-25
Model Number24653
Catalog Number24653
Lot Number0023633476
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressTWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-29

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