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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ATRIUM ICAST COVERED STENT; PTFE COVERED STENT
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ATRIUM MEDICAL CORPORATION ATRIUM ICAST COVERED STENT; PTFE COVERED STENT Back to Search Results
Model Number 85415
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/15/2016
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This report is to link the (b)(4) with the manufacturer medwatch report.
 
Event or Problem Description
Report stated that a stent was inserted by the physician.Before the stent was in position, the physician noted the stent had moved off the balloon.The system was removed with the stent intact.No harm to the patient.
 
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Brand Name
ATRIUM ICAST COVERED STENT
Common Device Name
PTFE COVERED STENT
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
5 wentworth drive
hudson NH 03051
MDR Report Key5650628
Report Number1219977-2016-00076
Device Sequence Number18874673
Product Code JCT
UDI-Device Identifier00650862854152
UDI-Public00650862854152
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
K050814
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 04/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Physician
Device Expiration Date11/25/2018
Device Model Number85415
Device Catalogue Number85415
Device Lot Number231376
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/28/2016
Initial Report FDA Received Date05/12/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age78 YR
Patient Weight69
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