BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 2211901 · Received August 15, 2011

    Report

    Report Number
    2024168-2011-05735
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. EVALUATION SUMMARY: EVALUATION OF THE RETURNED PRODUCT FOUND NO BLOOD OR CONTRAST VISIBLE. THE STENT IMPLANT WAS RETURNED DISLODGED FROM THE BALLOON AND LOCATED ON THE STYLET AND INSIDE THE ORANGE PROTECTIVE SHEATH, CONFIRMING THE REPORTED DISLODGEMENT. THERE WAS ONE BENT DISTAL STRUT ON THE SECOND ROW OF THE STENT IMPLANT. CRIMP MARKS WERE VISIBLE ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THERE WERE MULTIPLE BENDS IN THE STYLET CONSISTENT WITH HOW IT WAS RETURNED TWISTED IN A KNOT. THERE WAS A BEND IN THE HYPOTUBE AT THE DISTAL END OF THE STRAIN RELIEF TUBING. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE BEND MAY HAVE OCCURRED DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THIS DAMAGE DOES NOT APPEAR TO BE RELATED TO OR HAVE CONTRIBUTED TO THE REPORTED STENT DISLODGEMENT. THE INNER DIAMETER OF THE PROTECTIVE SHEATH AND STENT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. 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 STENT DELIVERY SYSTEM (SDS), NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, OR HANDLING OF THE STENT DURING DEVICE PREPARATION. TO ENSURE THIS IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, 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. IN THIS CASE, IT IS POSSIBLE THE STENT AND PROTECTIVE SHEATH WERE INADVERTENTLY HANDLED DURING REMOVAL, RESULTING IN THE STENT DISLODGING FROM THE BALLOON AND THE NOTED STENT DAMAGE; HOWEVER THIS COULD NOT BE CONFIRMED. 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. A CONCLUSIVE CAUSE FOR THE REPORTED STENT DISLODGMENT COULD NOT BE DETERMINED; HOWEVER THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INSERTION ON THE GUIDE WIRE THE MINI VISION STENT CAME OFF THE STENT DELIVERY SYSTEM (SDS). A NON-ABBOTT SDS WAS SUCCESSFULLY USED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE OR THERAPY. 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 1020941

    Patients

    Seq Age Sex Outcome Treatment
    1