CONCERTO NYLON NV-3-8-HELIX

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 2020-03-18 for CONCERTO NYLON NV-3-8-HELIX manufactured by Micro Therapeutics, Inc. Dba Ev3.

Event Text Entries

[184170568] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[184170569] Medtronic received a report that the concerto coil did not detach during the procedure. No additional information was provided at the time of the report, and there was no patient harm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2029214-2020-00256
MDR Report Key9851225
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-18
Date of Report2020-03-18
Date of Event2019-12-24
Date Mfgr Received2020-03-17
Device Manufacturer Date2019-08-26
Date Added to Maude2020-03-18
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 ContactKATCHA TAYLOR
Manufacturer Street9775 TOLEDO WAY
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9496801345
Manufacturer G1MICRO THERAPEUTICS, INC. DBA EV3
Manufacturer Street9775 TOLEDO WAY
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal Code92618
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCONCERTO NYLON
Generic NameDEVICE, EMBOLIZATION, VASCULAR
Product CodeKRD
Date Received2020-03-18
Model NumberNV-3-8-HELIX
Catalog NumberNV-3-8-HELIX
Lot NumberA888816
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMICRO THERAPEUTICS, INC. DBA EV3
Manufacturer Address9775 TOLEDO WAY IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-18

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