BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2072087 · Received April 28, 2011

    Report

    Report Number
    2024168-2011-02969
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 6, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    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. GUIDE WIRE: BMW UNIVERSAL II; INFLATION: PEROUSE MEDICAL; GUIDE CATH: LAUNCHER; SHEATH: TERUMO 6 F. EVALUATION SUMMARY: EVALUATION OF THE RETURNED VISION STENT DELIVERY SYSTEM (SDS) NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND ON THE BALLOON AND CONTRAST ON THE BALLOON AND IN THE INFLATION LUMEN, CONSISTENT WITH PREPARATION AND HANDLING. THE STENT IMPLANT WAS DISLODGED FROM THE BALLOON AND WAS NOT RETURNED, CONFIRMING THE REPORTED INFORMATION. CRIMP MARKS WERE VISIBLE ON THE LOOSELY FOLDED BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. FACTORS WHICH MAY CONTRIBUTE TO RESISTANCE WITH A GUIDING CATHETER INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, DAMAGE TO THE STENT, DAMAGE TO THE GUIDING CATHETER, OR PROCEDURAL TECHNIQUE. IT IS POSSIBLE THE SDS WAS NOT PROPERLY SUPPORTED DURING ADVANCEMENT IN THE GUIDING CATHETER, RESULTING IN THE REPORTED RESISTANCE AS THE SDS INTERACTED WITH GUIDING CATHETER. FURTHER INTERACTION AS THE SDS WAS MANIPULATED IN THE GUIDING CATHETER WOULD HAVE RESULTED IN THE STENT ULTIMATELY DISLODGING FROM THE BALLOON. THE GUIDING CATHETER WAS NOT RETURNED FOR ANALYSIS; THEREFORE, IT IS UNKNOWN HOW IT MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. THERE WAS NO DAMAGE NOTED TO THE STENT PRIOR TO USE WHICH MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE CIRCUMFLEX ARTERY WITH MODERATE TORTUOSITY AND HEAVY CALCIFICATION, THE VISION STENT DISLODGED IN THE MID CIRCUMFLEX (CX) ARTERY BEFORE REACHING THE TARGET LESION. THE DISLODGED STENT WAS DEPLOYED IN THE MID CX, BUT NOT IN THE LESION. ADDITIONALLY, IT WAS NOTED THAT RESISTANCE WAS MET WHEN THE STENT DELIVERY SYSTEM WAS ADVANCING THROUGH THE GUIDING CATHETER. A SECOND STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. 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 0042241

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention| S