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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ATRIUM ICAST COVERED STENTS; PROSTHESIS, TRACHEAL, EXPANDABLE
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ATRIUM MEDICAL CORP. ATRIUM ICAST COVERED STENTS; PROSTHESIS, TRACHEAL, EXPANDABLE Back to Search Results
Model Number 85442
Device Problems Detachment Of Device Component (1104); Positioning Problem (3009)
Patient Problem No Code Available (3191)
Event Date 08/12/2014
Event Type  Injury  
Event Description
The report received states that during a fenestrated abdominal aortic aneurysm procedure using a femoral approach, the stent delivery catheter was passing through the valve and the stent came off the balloon.A dilator was used to insert the sheath.The stent did not enter the pt.
 
Manufacturer Narrative
On completion of the investigation, a f/u report will be submitted.
 
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Brand Name
ATRIUM ICAST COVERED STENTS
Type of Device
PROSTHESIS, TRACHEAL, EXPANDABLE
Manufacturer (Section D)
ATRIUM MEDICAL CORP.
hudson NH 03051
Manufacturer Contact
lynda mclaughlin
5 wentworth dr.
hudson, NH 03051
6038645470
MDR Report Key4024149
MDR Text Key4729543
Report Number1219977-2014-00245
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 Physician
Type of Report Initial
Report Date 08/12/2014
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
Device Operator Health Professional
Device Expiration Date12/31/2016
Device Model Number85442
Device Catalogue Number85442
Device Lot Number10925083
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/12/2014
Initial Date FDA Received08/15/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2013
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
ROSEN WIRE; 6 FR 55 CM ANSEL SHEATH WITH HIGH FLEX DILATOR
Patient Outcome(s) Required Intervention;
Patient Age74 YR
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