BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION OTW CORONARY STENT SYSTEM

    MDR report key: 2021726 · Received March 17, 2011

    Report

    Report Number
    2024168-2011-01786
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    January 17, 2011
    Report Date
    February 20, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF ANGINA AND RESTENOSIS, AS LISTED IN THE MINI VISION INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. 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 ON (B)(6) 2010, A 2.5 X 23 MM MULTI-LINK MINI VISION STENT WAS PLACED INSIDE A THROMBOSED DRUG ELUTING STENT IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MLAD). ON (B)(6) 2011, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH CHEST PAIN. ON (B)(6) 2011, CORONARY ARTERY BYPASS WAS PERFORMED DUE TO THE CHRONIC STENOSIS IN THE MLAD. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED AND ON (B)(6) 2011, THE PATIENT WAS DISCHARGED. 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-TEMECULA-CT 0042641

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| S STENT: ENDEAVOR, XIENCE V 2.5X15MM