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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL ICAST COVERED STENT; PROSTHESIS, TRACHEAL
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ATRIUM MEDICAL ICAST COVERED STENT; PROSTHESIS, TRACHEAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Blood Loss (2597); Vascular Dissection (3160)
Event Type  Injury  
Manufacturer Narrative
A complete investigation was not able to be performed as no product code, lot number or sample was provided.Per the study, percutaneous endovascular treatment using a covered stent may be a safe and feasible tool for sma pseudoaneurysms.
 
Event Description
Received an article titled "endovascular treatment of superior mesenteric artery pseudoaneurysms using covered stents in six patients" published in the vascular and interventional radiology.The article evaluated an experience with the use of endovascular treatments for superior mesenteric artery (sma) pseudoaneurysms using covered stents.Per the article, adverse events included dissection and blood loss.
 
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Brand Name
ICAST COVERED STENT
Type of Device
PROSTHESIS, TRACHEAL
Manufacturer (Section D)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer Contact
40 continental blvd
merrimack, NH 03054
MDR Report Key8135359
MDR Text Key129433502
Report Number3011175548-2018-01457
Device Sequence Number1
Product Code JCT
Combination Product (y/n)N
PMA/PMN Number
K080514
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Reporter Occupation Physician
Type of Report Initial
Report Date 12/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2018
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 Received11/16/2018
Was Device Evaluated by Manufacturer? No
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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