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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ATRIUM ICAST COVERED STENT; PROSTHESIS, TRACHEAL, EXPANDIBLE
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ATRIUM MEDICAL CORP. ATRIUM ICAST COVERED STENT; PROSTHESIS, TRACHEAL, EXPANDIBLE Back to Search Results
Model Number 85418
Device Problems Component Missing (2306); Physical Resistance (2578); Device Dislodged or Dislocated (2923)
Patient Problem No Code Available (3191)
Event Date 03/13/2015
Event Type  Injury  
Event Description
The physician was treating a right iliac lesion coming up and over the bifurcation from the left side.The stent was inserted over the guide wire.The physician experienced resistance when pushing the stent through the sheath.It began to track again and when it came out of the sheath, they noticed that the stent was no longer there.They removed the catheter and then inserted a second stent through the same sheath over the same wire.This stent also became dislodged in the sheath.
 
Manufacturer Narrative
On completion of the investigation, a follow up report will be submitted.Associated file: 1219977-2015-00085.
 
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Brand Name
ATRIUM ICAST COVERED STENT
Type of Device
PROSTHESIS, TRACHEAL, EXPANDIBLE
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH 03051
Manufacturer Contact
lynda mclaughlin
5 wentworth dr.
hudson, NH 03051
6038645470
MDR Report Key4619370
MDR Text Key5653387
Report Number1219977-2015-00081
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 Not Applicable
Type of Report Initial
Report Date 03/13/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/31/2017
Device Model Number85418
Device Catalogue Number85418
Device Lot Number219969
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/13/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2014
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
0.035 STIFF GLIDEWIRE; 7 FR COOK ANSEL 45CM SHEATH
Patient Outcome(s) Required Intervention;
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