BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1903910 · Received November 20, 2010

    Report

    Report Number
    2024168-2010-02483
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 27, 2010
    Manufacturer
    AV-CLONMEL
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). POTENTIAL FACTORS FOR THE STENT LENGTHENING/SHORTENING INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, INCORRECT LABELING ON THE DEVICE AND ANATOMICAL CONDITIONS. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE CINE WAS REVIEWED BY AN ABBOTT VASCULAR CLINICAL SPECIALIST, AND THE RESULTS DO NOT SUGGEST THAT THE DEPLOYED STENT IS LONGER THAT THE PRE-DEPLOYED STENT. A STENT IS POSITIONED ACROSS THE LESION. IN THE UNDEPLOYED STATE THE STENT EDGES ALIGN WITH THE BALLOON MARKERS. THE STENT IS DEPLOYED. WITH THE DELIVERY SYSTEM BALLOON EXPANDED, THERE IS NO STENT SHADOW VISIBLE BEYOND EITHER BALLOON EDGE. WITH THE DELIVERY SYSTEM REMOVED, THE EDGES OF THE STENT SHADOW ALIGN WITHIN THE VASCULAR BED LANDMARKS (SMALL BRANCH TAKE-OFFS FROM THE RCA) AS SEEN AFTER STENT POSITIONING AND DEPLOYMENT. SEVERAL POST-DILATATIONS ARE THEN PERFORMED ALONG WITH INTRA VASCULAR ULTRA-SOUND (IVUS). THE IVUS IMAGES WERE NOT MADE AVAILABLE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT. BASED ON THE REPORTED INFORMATION AND REVIEW OF THE CINE, A CONCLUSIVE CAUSE FOR THE REPORTED STENT LENGTHENING COULD NOT BE DETERMINED AS THIS COULD NOT BE CONFIRMED IN THE CINE AND THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF AN UNSPECIFIED VESSEL, THE VISION STENT WAS IMPLANTED AT THE LESION. IT WAS NOTED BY USING INTRAVASCULAR ULTRASOUND (IVUS) THAT THE DEPLOYED STENT SEEMED TO BE LONGER THAN 28MM; IT SUGGESTS THE TOTAL STENT LENGTH WAS INCREASED BY 2-3MM COMPARED WITH THE LABELED SIZE. WHEN THE STENT DELIVERY SYSTEM (SDS) BALLOON WAS POSITIONED FOR POST-DILATATION OF THE STENT, THE STENT EDGE WAS LONGER THAN THE SDS MARKER. A CINE WAS USED AND CONFIRMED THAT THE STENT SEEMED TO BE LONGER. ADDITIONALLY, REVIEW OF THE CINE BY THE ABBOTT CLINICAL STATED THAT IN THE UNDEPLOYED STATE THE STENT EDGES ALIGN WITH THE BALLOON MARKERS. THE STENT IS DEPLOYED. WITH THE DELIVERY SYSTEM BALLOON EXPANDED THERE IS NO STENT SHADOW VISIBLE BEYOND EITHER BALLOON EDGE. WITH THE DELIVERY SYSTEM REMOVED, THE EDGES OF THE STENT SHADOW ALIGN WITHIN THE VASCULAR BED LANDMARKS (SMALL BRANCH TAKE-OFFS FROM THE RCA) AS SEEN AFTER STENT POSITIONING AND DEPLOYMENT. THOUGH REQUESTED, 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-CLONMEL 8042831

    Patients

    Seq Age Sex Outcome Treatment
    1