MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-16 for manufactured by Boston Scientific Corporation.

Event Text Entries

[183515966] Date of event - estimated based on the aware date of (b)(6) 2020.
Patient Sequence No: 1, Text Type: N, H10


[183515967] It was reported via social media that stent fracture occurred. It was reported that a patient had 20 stents placed in their heart and two, which were implanted in a horseshoe vessel, have "broken in half". The patient remains in hospice care.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134265-2020-02890
MDR Report Key9834945
Report SourceCONSUMER
Date Received2020-03-16
Date of Report2020-03-16
Date of Event2020-02-01
Date Mfgr Received2020-02-24
Date Added to Maude2020-03-16
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 SCIMED, INC
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Product CodeMCX
Date Received2020-03-16
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 2020-03-16

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