BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2336246 · Received November 14, 2011

    Report

    Report Number
    2024168-2011-07713
    Event Type
    Injury
    Date Received
    November 14, 2011
    Date of Event
    March 24, 2011
    Report Date
    October 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 AND THE PRODUCT WAS NOT RETURNED. ISCHEMIA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE VISION CORONARY STENT SYSTEM INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP, IF ANY, TO THE DEVICE 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 APPROXIMATELY 17 MONTHS AFTER 2 RX VISION STENTS WERE IMPLANTED IN THE PROXIMAL AND MID RIGHT CORONARY ARTERY (RCA), THE PATIENT HAD AN ABNORMAL CARDIAC STRESS TEST. THE PATIENT UNDERWENT ANGIOPLASTY IN THE RESTENOSED PROXIMAL RCA. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. 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 9051941

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R STENT: RX VISION