BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION OTW CORONARY STENT SYSTEM

    MDR report key: 1920150 · Received December 10, 2010

    Report

    Report Number
    2024168-2010-02660
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    September 15, 2010
    Report Date
    November 16, 2010
    Manufacturer
    AV-CLONMEL
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED RESTENOSIS IS A KNOWN ADVERSE EVENT LISTED IN THE MINI VISION INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS 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 A MULTILINK MINI VISION STENT WAS PLACED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE PATIENT HAD A STRESS TEST WHICH REVEALED NO BLOOD SUPPLY AT THE BACK OF THE HEART AND REVASCULARIZATION WITH A 2.75 X 23 MM NON-ABBOTT DRUG ELUTING STENT WAS PERFORMED INSIDE THE STENT. THERE WAS NO REPORTED ISSUE. THERE WAS NO REPORTED PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION OTW CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-CLONMEL 6013131

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R