I-CAST COVERED STENT 85417

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-15 for I-CAST COVERED STENT 85417 manufactured by Atrium Medical Corporation.

Event Text Entries

[186753297] On completion of the investigation a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[186753298] Customer report of icast stent catheter not able to cross lesion to treat intended stenosis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011175548-2020-00408
MDR Report Key9833185
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-15
Date of Report2020-03-15
Date of Event2020-03-02
Date Mfgr Received2020-03-09
Device Manufacturer Date2019-10-09
Date Added to Maude2020-03-15
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 ContactMS. LYNDA MCLAUGHLIN
Manufacturer Street40 CONTINENTAL BLVD
Manufacturer CityMERRIMACK NH 03054
Manufacturer CountryUS
Manufacturer Postal03054
Manufacturer G1ATRIUM MEDICAL CORPORATION
Manufacturer Street40 CONTINENTAL BLVD
Manufacturer CityMERRIMACK NH 03054
Manufacturer CountryUS
Manufacturer Postal Code03054
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameI-CAST COVERED STENT
Generic NamePROSTHESIS, TRACHEAL, EXPANDABLE
Product CodeJCT
Date Received2020-03-15
Model Number85417
Catalog Number85417
Lot Number452080
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerATRIUM MEDICAL CORPORATION
Manufacturer Address40 CONTINENTAL BLVD MERRIMACK NH 03054 US 03054


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-15

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