ICAST COVERED STENT SYSTEM

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 2020-01-23 for ICAST COVERED STENT SYSTEM manufactured by Atrium Medical Corporation.

Event Text Entries

[186849450] A complete investigation was not able to be performed as no product code, lot number or sample was provided. Per the study, these early and intermediate results, which incorporated physician learning curves, support the safety and feasibility of the off-the-shelf zenith p-branch device. Device not returned.
Patient Sequence No: 1, Text Type: N, H10


[186849451] Received an article titled results from a prospective multicenter feasibility study. Purpose: to evaluate the cook zenith p-branch stent graft for the treatment of patients with asymptomatic juxtarenal or pararenal abdominal aortic aneurysms in a prospective nonrandomized, multicenter, feasibility study conducted in the united states. Method: 30 patients were enrolled from january 2013 - june 2015. Per the article product problems included kinking.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011175548-2020-00125
MDR Report Key9622391
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-01-23
Date of Report2020-01-23
Date Mfgr Received2020-01-17
Date Added to Maude2020-01-23
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 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 NameICAST COVERED STENT SYSTEM
Generic NamePROSTHESIS, TRACHEAL, EXPANDABLE
Product CodeJCT
Date Received2020-01-23
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 2020-01-23

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