ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM 24620

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 2020-03-13 for ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM 24620 manufactured by Boston Scientific Corporation.

Event Text Entries

[183371863] (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[183371864] (b)(6) trial it was reported that stent occlusion occurred. Subject enrolled in the study on (b)(6) 2016 and index procedure was performed that day. The target lesions were in the left proximal superficial femoral artery and the left mid-superficial femoral artery. A 6mmx150mmx130cm drug eluting study stent and a 6mmx100mmx75cm drug eluting study stent were implanted. On (b)(6) 2020, 3 years, 26 days post index procedure, left superficial femoral in-stent occlusion was noted. On (b)(6) 2020, subject was hospitalized and an interventional procedure was performed. On (b)(6) 2020 the subject was discharged and the event was considered resolved.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-03161
MDR Report Key9831062
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-13
Date of Report2020-03-13
Date of Event2020-01-08
Date Mfgr Received2020-02-21
Device Manufacturer Date2016-01-27
Date Added to Maude2020-03-13
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 StreetTWO SCIMED PLACE
Manufacturer CityMAPLE GROVE MN 55311
Manufacturer CountryUS
Manufacturer Postal Code55311
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
Product CodeNIU
Date Received2020-03-13
Model Number24620
Catalog Number24620
Lot Number0018779191
Device Expiration Date2016-12-31
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. Hospitalization; 2. Required No Informationntervention 2020-03-13

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