BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1993949 · Received February 16, 2011

    Report

    Report Number
    2024168-2011-00932
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). GUIDE WIRE: BMW. INFLATION: MEDTRONIC. GUIDE CATH: 6F JL 3.5. SHEATH: CORDIS. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF DISSECTION, AS LISTED IN THE VISION INSTRUCTIONS FOR USE (IFU), IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. DISSECTIONS CAN BE INFLUENCED BY SEVERAL FACTORS INCLUDING, BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND DEVICE SIZE SELECTION. IT SHOULD BE NOTED THAT THE IFU STATES, IMPLANTING A STENT MAY LEAD TO DISSECTION OF THE VESSEL DISTAL AND / OR PROXIMAL TO THE STENT AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION (CABG, FURTHER DILATATION, PLACEMENT OF ADDITIONAL STENTS, OR OTHER). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED DISSECTION AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LESION IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS STENTED DIRECTLY WITH A VISION 2.75 X 12. WHILE STENTING, A DISSECTION OCCURRED AT THE PROXIMAL EDGE OF THE STENT. THE DISSECTION WAS TREATED WITH A VISION 3.0 X 18. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND PATIENT IS DOING WELL. THERE WAS NO DELAY IN THE PROCEDURE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 0052641

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention SEE H10 FOR CONCOMITANT MEDICAL DEVICES