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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ICAST COVERED STENT; PROSTHESIS, TRACHEAL, EXPANDIBLE
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ATRIUM MEDICAL CORP. ICAST COVERED STENT; PROSTHESIS, TRACHEAL, EXPANDIBLE Back to Search Results
Model Number 85453
Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 02/26/2015
Event Type  Injury  
Event Description
Stent was delivered through brachial artery via a introducer sheath.When the stent came out of the sheath, it was half way off the balloon.The stent was never deployed and was removed from the body.
 
Manufacturer Narrative
We are awaiting the return of the device for investigation and will submit the follow-up report once the evaluation is completed.
 
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Brand Name
ICAST COVERED STENT
Type of Device
PROSTHESIS, TRACHEAL, EXPANDIBLE
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH
Manufacturer Contact
lori gosselin, sr coord
5 wentworth dr.
hudson, NH 03051
6038801433
MDR Report Key4600076
MDR Text Key21553753
Report Number1219977-2015-00072
Device Sequence Number1
Product Code JCT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050814
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/31/2017
Device Model Number85453
Device Catalogue Number85453
Device Lot Number216915
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/26/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
6FR COOK INTRODUCER SHEATH
Patient Outcome(s) Required Intervention;
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