BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1912549 · Received December 2, 2010

    Report

    Report Number
    2024168-2010-02574
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    January 29, 2010
    Report Date
    November 7, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 EFFECT OF RESTENOSIS, AS LISTED IN THE VISION INSTRUCTIONS FOR USE (IFU), IS A KNOWN ADVERSE EVENT 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. THE 2.75 X 23 MM VISION ((B)(4) UNK) IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA STUDY THAT APPROXIMATELY 2 MONTHS POST RX VISION STENT IMPLANTATION IN THE DISTAL AND MID RIGHT CORONARY ARTERY (DRCA, MRCA), THE STENTS WERE FOUND TO BE RESTENOSED. THE DRCA HAD 80% IN-STENT RESTENOSIS (ISR) AND THE MRCA HAD 70% ISR. AN RX XIENCE STENT WAS PLACED WITHIN EACH STENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND ONE DAY POST PROCEDURE THE PATIENT WAS DISCHARGED TO HOME. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION 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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R 2.75 X 23 MM VISION ((B)(4), UNK)