BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1772374 · Received July 23, 2010

    Report

    Report Number
    2024168-2010-01479
    Event Type
    Injury
    Date Received
    July 23, 2010
    Date of Event
    June 29, 2010
    Report Date
    June 30, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT IS NOT LIMITED TO, PT ANATOMICAL MORPHOLOGY, PT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. REPORTEDLY, THE LESION WAS HEAVILY CALCIFIED WHICH LIKELY CONTRIBUTED TO THE INABILITY TO CROSS THE TARGET LESION. THE REPORTED OCCLUSION IS LISTED IN THE INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING AND IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. ADDITIONALLY, OCCLUSION AND THERAPY/NON-SURGICAL ADDITIONAL TREATMENT ARE LISTED IN THE RISK ASSESSMENT MATRIX AS NO-FAULT COMPLICATIONS. ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO A 100% VISUAL INSPECTION. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    DEVICE ISSUE: FAILURE TO CROSS. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: PLAQUE SHIFT CAUSING AN OCCLUSION/REQUIRING TREATMENT. TIME OF ADVERSE EVENT: DURING THE PROCEDURE. IT WAS PLANNED TO TREAT A TOTAL OCCLUSION IN THE CIRCUMFLEX BRANCH OF THE LEFT CORONARY ARTERY. REPORTEDLY, THE GUIDE WIRE (UNK MFR) WAS PLACED THROUGH THE OCCLUSION AND PRE-DILATION OF THE TARGET LESION WAS DONE WITH A BALLOON (UNK MFR). THE ML VISION 2.75 X 15 MM WAS ADVANCED TOWARDS THE TARGET LESION BUT COULD NOT BE MOVED BEYOND THE CURVE WHERE THE CIRCUMFLEX ARTERY GIVES OFF THE LEFT MAIN CORONARY ARTERY AND THE BIFURCATION WAS TOO NARROW. THE ML VISION 2.75 X 15 MM WAS RETRACTED AND THE TARGET LESION WAS PRE-DILATED A SECOND TIME WITH A NEW BALLOON (UNK MFR). A ML VISION 2.75 X 8MM, WAS ADVANCED, BUT COULD NOT BE MOVED OVER THE CURVE / BIFURCATION. THE ML VISION 2.75 X 8MM WAS RETRACTED WITHOUT DIFFICULTIES. AFTER REMOVAL, THE AREA OF THE LEFT CORONARY ARTERY BEFORE THE CIRCUMFLEX ARTERY, SHOWED AN OCCLUSION. REPORTEDLY, SOME PLAQUE FROM THE OCCLUSION IN THE CIRCUMFLEX ARTERY MIGHT HAVE BEEN SET FREE AND CAUSED THE ADDITIONAL OCCLUSION. THIS NEW OCCLUSION WAS EMERGENCY TREATED (UNK WHAT EXACTLY WAS DONE). THE TARGET LESION (OCCLUSION IN THE CIRCUMFLEX ARTERY) WAS NOT FURTHER TREATED. NO ADDITIONAL INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STENT: ML VISION 2.75 X 15