I-CAST COVERED STENT 85453

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study,use report with the FDA on 2020-03-05 for I-CAST COVERED STENT 85453 manufactured by Atrium Medical Corporation.

Event Text Entries

[182291229] On completion of the investigation a follow up report will be submitted. Device evaluated by manufacturer? Not available for return.
Patient Sequence No: 1, Text Type: N, H10


[182291230] 86 days post-procedure the patient was diagnosed with an occlusion of the right renal stent, occlusion or the left renal stent, bilateral renal infarct, and left iliac graft occlusion. Renal occlusions were treated by thrombectomy and additional stent placement. Occlusion in the iliac graft was treated by femoral-femoral bypass.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011175548-2020-00366
MDR Report Key9796159
Report SourceHEALTH PROFESSIONAL,STUDY,USE
Date Received2020-03-05
Date of Report2020-03-05
Date of Event2020-02-27
Date Mfgr Received2020-03-02
Device Manufacturer Date2019-07-13
Date Added to Maude2020-03-05
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 Received2020-03-05
Model Number85453
Catalog Number85453
Lot Number448461
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
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 2020-03-05

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