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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ATRIUM ADVANTA V12 COVERED STENT; PTFE COVERED STENT
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ATRIUM MEDICAL CORP. ATRIUM ADVANTA V12 COVERED STENT; PTFE COVERED STENT Back to Search Results
Device Problem Difficult To Position (1467)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description
Received an article titled 'radiofrequency in situ fenestration for aortic arch vessels during thoracic endovascular repair' that was published on the journal of endovascular therapy 2015, vol 22 (i) 116-121.The study consisted of data collected between june 2011 and december 2013 in which 40 thoracic endovascular aortic repair (tevar) procedures were performed, including 10 cases which in situ fenestration was planned.Per the study, a physician had difficulty positioning the stent.
 
Manufacturer Narrative
A complete investigation was not able to be performed as no product code and lot number was provided.Per the study, radiofrequency puncture is a viable alternative to needle and laser punctures for retrograde in situ stent-graft fenestration during tevar.Early clinical results suggest technical feasibility and acceptable early outcomes.
 
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Brand Name
ATRIUM ADVANTA V12 COVERED STENT
Type of Device
PTFE COVERED STENT
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH 03051
Manufacturer Contact
lynda mclaughlin
5 wentworth dr.
hudson, NH 03051
6038645470
MDR Report Key4663433
MDR Text Key5620083
Report Number1219977-2015-00101
Device Sequence Number1
Product Code JCT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/23/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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