BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1895022 · Received November 5, 2010

    Report

    Report Number
    2024168-2010-02368
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    April 27, 2010
    Report Date
    October 13, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PT 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 PT 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 3.0 X 23 MM MULTI-LINK RX VISION (PART 1007842-23J, LOT UNK), INDICATED IS BEING FILE UNDER A SEPARATE MFR#.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO VISION STENTS WERE IMPLANTED IN THE RCA LESION ON (B)(6) 2009. ON (B)(6) 2010, A 3.5 X 28 MM AND A 3.5 X 18 MM XIENCE V STENT WERE IMPLANTED IN THE LESION BECAUSE OF THE RESTENOSIS OF THE VISION STENTS. THE STENOSIS IMPROVED FROM 90% TO 0%. THE VESSEL DIAMETER AND LENGTH IN WHICH XIENCE V STENTS WERE IMPLANTED: 3.5 MM AND 40 MM. NO PT EFFECTS WERE REPORTED. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R MULTI-LINK RX VISION (PART 1007842-23J, LOT UNK)| STENT: 3.0 X 23 MM| GUIDE: CATH: HEARTRAIL 6F IR1.0| VOYAGER NC 3.5 X 15MM| DILATATION CATHETER: TAZUNA 3.0 X 15MM| HIRYU 3.5 X 20MM| GUIDE WIRE: RUNTHOUGH, EXTRA FLOPPY, PT2