BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRIUM ICAST COVERED STENTS

    MDR report key: 3960372 · Received July 17, 2014

    Report

    Report Number
    1219977-2014-00205
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 18, 2014
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    JCT
    PMA / PMN Number
    K050814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IN QUESTION WAS NOT RETURNED FOR EVALUATION, THEREFORE AN INSPECTION TO ENSURE THE WITNESS LINES OF THE CRIMPED STENT WERE VISIBLE WAS NOT ABLE TO BE PERFORMED (WHEN THE PRODUCT IS CRIMPED, THE STENT STRUTS IMPART PERMANENT IMPRINTS TO THE EXTERIOR OF THE BALLOON). THE DIAMETER OF THE STENT COULD NOT BE MEASURED TO ENSURE THAT THE DIAMETER MATCHED THE MEASUREMENTS TAKEN DURING THE QUALITY FINAL INSPECTION. THE INTRODUCER SHEATH USED IN THE CASE WAS NOT RETURNED AS WELL THUS AN INSPECTION OF THE SHEATH DIMENSION AND OVERALL CONDITION COULD NOT BE ASSESSED. A FULL OF REVIEW OF THE CATHETER LOT HISTORY RECORDS FOR THE DEVICE IN QUESTION WAS PERFORMED. THE RECORDS INDICATE THAT THIS LOT OF CATHETERS PASSED ATRIUMS FINAL LOT QUALIFICATION TESTING. THIS INSPECTION REQUIRES THAT THE CATHETER LOT MUST PASS THE FOLLOWING. ABILITY OF THE STENT AND DELIVERY SYSTEM TO BE PASSED THROUGH THE LABELED INTRODUCER SHEATH. ABILITY TO DEPLOY THE STENT AND NOMINAL PRESSURE (8ATM). ABILITY TO WITHDRAW THE DEFLATED BALLOON CATHETER BACK THROUGH THE LABELED INTRODUCER SHEATH. ABILITY OF THE DELIVERY SYSTEM TO WITHSTAND 5 INFLATE. RESULT: THE DETAILS OF THE COMPLAINT INDICATE THAT THE STENT WAS DISLODGED WHILE ATTEMPTING TO PASS THE STENT THROUGH A TIGHT LESION. IT IS POSSIBLE THAT THE LESION WAS OF A DIAMETER THAT WAS SMALLER THAN THE CRIMPED STENT OUTER DIAMETER OF THE I-CAST COVERED STENT. THIS COULD CAUSE THE STENT TO DISLODGE IF ENOUGH FORCE WAS GENERATED WHILE ATTEMPTING TO PASS THE STENT THROUGH THE LESION.

    Description of Event or Problem · 1

    THE STENT SLIPPED OFF THE BALLOON WHEN THE DOCTOR WAS TRYING TO CROSS A TIGHT LESION. HE WAS ABLE TO RETRIEVE THE STENT AND USED A NEW STENT TO FINISH THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420469 ATRIUM ICAST COVERED STENTS PROSTHESIS, TRACHEAL, EXPANDABLE JCT ATRIUM MEDICAL CORP. 85451 10881195

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention 7 FR ANSEL 3 SHEATH