BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 2210807 · Received August 12, 2011

    Report

    Report Number
    2024168-2011-05712
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A LOOSE STENT CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, INADEQUATE CRIMPING DURING MANUFACTURING, INCORRECT SHEATH SIZING, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING DURING PRODUCT PREPARATION FOR USE, OR INTERACTION WITH ACCESSORY DEVICES. TO ENSURE THIS TYPE OF OCCURRENCE IS NOT A RESULT OF A POTENTIAL MANUFACTURING OR 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. A SAMPLING OF UNITS IS ALSO SUBJECTED TO A STENT MOVEMENT TEST TO VERIFY STENT SECURITY. RETURN OF THE MINI VISION STENT DELIVERY SYSTEM MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE. IT IS POSSIBLE THE STENT INTERACTED WITH THE GUIDING CATHETER, RESULTING IN THE STENT BECOMING LOOSE; HOWEVER, THIS COULD NOT BE CONFIRMED. IN THIS CASE, WITHOUT THE PRODUCT TO EXAMINE A CONCLUSIVE CAUSE FOR THE LOOSE STENT COULD NOT BE DETERMINED. A SEARCH OF THE LOT HISTORY RECORD INDICATED NO NONCONFORMANCES FOR THE LOT AND A SEARCH OF THE COMPLAINT DATABASE INDICATED NO RELATED INCIDENTS. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). INTERNAL FILE NUMBER - (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE STENT DELIVERY SYSTEM HAD EXITED THE GUIDING CATHETER, PRIOR TO REACHING THE LESION SITE IN THE CIRCUMFLEX THAT HAD MILD CALCIFICATION, THE STENT WAS NOTED TO HAVE MOVED OR WAS LOOSE ON THE STENT DELIVERY SYSTEM. THE STENT DELIVERY SYSTEM, ALONG WITH THE STENT STILL MOUNTED WAS REMOVED WITH NO ISSUE AND THERE WAS NO PATIENT INJURY. ANOTHER MINI VISION OF THE SAME SIZE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTED AS FINE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 1030741

    Patients

    Seq Age Sex Outcome Treatment
    1