BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2833798 · Received November 15, 2012

    Report

    Report Number
    2024168-2012-07191
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 20, 2012
    Report Date
    October 22, 2012
    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). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED DISSECTION IS LISTED IN THE VISION INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MILDLY CALCIFIED, MILDLY TORTUOUS, MID RIGHT CORONARY ARTERY. PREDILATATION WAS PERFORMED PRIOR TO STENTING OF THE LESION WITH A 3.5X18 MM VISION STENT; HOWEVER, AFTER DEPLOYMENT, A DISSECTION WAS OBSERVED AT THE DISTAL EDGE OF THE DEPLOYED STENT. A 3.5X12 MM VISION STENT WAS USED TO TREAT THE DISSECTION SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. 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 2071241

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention