BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2001520 · Received February 25, 2011

    Report

    Report Number
    2024168-2011-01188
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. POTENTIAL FACTORS THAT CAN CONTRIBUTE TO STENT DISLODGEMENT OUTSIDE THE BODY PRIOR TO USE MAY INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, POSITIVE PRESSURE DURING PREPARATION OF THE SDS, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, OR HANDLING OF THE STENT DURING DEVICE PREPARATION. RETURN OF THE VISION SDS AND DISLODGED STENT MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE. IT WAS REPORTED THE STENT DISLODGEMENT WAS NOT NOTED UNTIL THE SDS WAS ADVANCED TO THE LESION AND THE BALLOON INFLATED. IT SHOULD BE NOTED THE VISION INSTRUCTIONS FOR USE (IFU) STATES: PRIOR TO USING THE MULTI-LINK VISION RX OR MULTI-LINK VISION OTW CORONARY STENT SYSTEM, CAREFULLY REMOVE THE SYSTEM FROM THE PACKAGE AND INSPECT FOR BENDS, KINKS, AND OTHER DAMAGE. VERIFY THAT THE STENT DOES NOT EXTEND BEYOND THE RADIOPAQUE BALLOON MARKERS. DO NOT USE IF ANY DEFECTS ARE NOTED. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO SIMILAR INCIDENTS REPORTED FOR STENT DISLODGEMENT FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. IN THIS CASE, WITHOUT THE PRODUCT TO EXAMINE, A CONCLUSIVE CAUSE FOR THE REPORTED STENT DISLODGEMENT COULD NOT BE DETERMINED. ALL SDS ARE INSPECTED FOR PROPER STENT PLACEMENT, STENT DAMAGE AND CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED PRIOR TO RELEASE TO VERIFY STENT DISLODGEMENT FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PLANNED STENTING PROCEDURE, PRE-DILATATION OF THE MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA) LESION WAS PERFORMED WITH A 3.5 X 15 MM TREK BALLOON, DURING WHICH, A DISSECTION WAS NOTED. THE PLANNED 4.0 X 23 MM RX VISION WAS INSERTED INTO THE RCA AND POSITIONED AT THE SITE OF THE LESION AND DISSECTION. THE STENT DELIVERY SYSTEM (SDS) BALLOON WAS INFLATED, BUT NO STENT WAS NOTED IN THE VESSEL. THE SDS WAS REMOVED FROM THE PATIENT AND THE STENT WAS FOUND ON THE FLOOR. IT HAD DISLODGED AND REMAINED ON THE MANDREL. A VISION 4.0 X 28 MM WAS USED TO SUCCESSFULLY TREAT BOTH THE LESION AND THE DISSECTION. NO FURTHER PATIENT EFFECTS WERE REPORTED. 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-TEMECULA-CT 0010841

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR