BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1852141 · Received September 28, 2010

    Report

    Report Number
    2024168-2010-02026
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 3, 2010
    Manufacturer
    ABBOTT VASCULAR-CLONMEL
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH BLOOD ON THE BALLOON AND CONTRAST ON THE SHAFT, CONSISTENT WITH THE SDS BEING ADVANCED INTO THE ANATOMY AS REPORTED. THE STENT IMPLANT WAS DISLODGED FROM THE BALLOON AND WAS RETURNED LOOSE ON THE DISTAL SHAFT AS REPORTED. THERE WERE BENT STRUTS IN THE FIRST ROW OF THE DISTAL END OF THE STENT IMPLANT. THERE WAS NO OTHER DAMAGE NOTED TO THE STENT IMPLANT. THERE WERE CRIMP MARKS ON THE BALLOON BETWEEN THE MARKERS, INDICATING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THE BALLOON WAS TIGHTLY FOLDED, CONSISTENT WITH THE BALLOON NOT BEING INFLATED. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE PROTECTIVE SHEATH WAS NOT RETURNED. A SNAP GAUGE WAS USED TO MEASURE THE OUTER DIAMETERS OF THE STENT IMPLANT, WHICH MET THE MANUFACTURING CRITERIA. BASED ON THE REPORTED INFORMATION AND CONDITION OF THE RETURNED SDS, IT IS LIKELY THAT THE STENT INTERACTED WITH THE GUIDING CATHETER DURING INSERTION, WHICH CAUSED THE BENT STRUTS ON THE DISTAL END OF THE STENT AND THE STENT TO DISLODGE PROXIMALLY ONTO THE SHAFT. IT APPEARS THAT THE SDS CONTINUED TO BE ADVANCED AFTER THE STENT DISLODGED, CAUSING THE STENT TO SLIDE DOWN TO THE SIDEARM OF THE SDS. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. OVERALL, THE STENT DISLODGEMENT AND DAMAGE TO THE DISTAL END OF THE STENT APPEARS TO BE A RELATED INTERACTION WITH THE GUIDING CATHETER DURING INSERTION AND THERE IS NO INDICATION TO SUGGEST A PRODUCT RELATED DEFICIENCY. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT DAMAGE, STENT PLACEMENT/SECURITY AND DIMENSIONALLY INSPECTED TO VERIFY THE CRIMPED STENT OUTER DIAMETERS. ADDITIONALLY, A SAMPLING OF UNITS IS SUBJECTED TO A STENT MOVEMENT TEST TO VERIFY STENT SECURITY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION THE STENT WAS OKAY, BUT WHEN THE PHYSICIAN WAS TRYING TO DEPLOY IT, HE REALIZED THERE WAS NO STENT ON THE BALLOON. THE PHYSICIAN THEN REMOVED THE DEVICE AND SAW THAT THE STENT HAD STAYED IN THE Y CONNECTOR, IT HAD DISLODGED. THE STENT WAS REMOVED WITHOUT INTERVENTION. THERE WAS NO PT INJURY. NO ADDITIONAL INFO WAS PROVIDED.

    Description of Event or Problem · 1

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF ABBOTT VASCULAR-CLONMEL NA 0031041

    Patients

    Seq Age Sex Outcome Treatment
    1