BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 2061098 · Received April 18, 2011

    Report

    Report Number
    2024168-2011-02689
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 9, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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: ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD VISIBLE ON THE BALLOON AND CONTRAST ON THE SHAFT, CONSISTENT WITH HANDLING. THE STENT IMPLANT WAS DISLODGED FROM THE BALLOON AND NOT RETURNED. 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. THE TIP LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT ARE NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. IN THIS CASE, IT IS LIKELY THAT INTERACTION WITH THE HEAVILY CALCIFIED LESION CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE. ADDITIONALLY, AN INTERACTION WITH THE LESION/ANATOMY DURING THE ATTEMPT TO CROSS THE LESION MAY HAVE RESULTED IN AN INTERACTION WITH THE STENT IMPLANT THAT COULD HAVE CAUSED DAMAGE AND LOOSENED THE STENT ON THE BALLOON. FURTHER MANIPULATION WITH THE CALCIFIED LESION WOULD HAVE THEN LED TO THE STENT DISLODGING ONTO THE SHAFT. IT WAS REPORTED THERE WAS A BURR NOTED ON THE STENT AFTER THE STENT DELIVERY SYSTEM (SDS) WAS REMOVED FROM THE PATIENT ANATOMY. IT IS POSSIBLE THAT THE STENT WAS DAMAGED RESULTING IN THE STRUTS FLARING, WHICH COULD HAVE BEEN REPORTED AS A BURR; HOWEVER, AS THE STENT WAS NOT RETURNED, THIS COULD NOT BE VERIFIED. TO ENSURE THE REPORTED DIFFICULTIES ARE 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. THE REPORTED FAILURE TO ADVANCE AND STENT DISLODGEMENT APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE; HOWEVER, AS THE DISLODGED STENT WAS NOT RETURNED, THE REPORTED BURR ON THE STENT 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. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ADDITIONALLY, ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED ONLINE FOR STENT DAMAGE. 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 INITIALLY REPORTED THAT THE PROCEDURE WAS TO TREAT A CALCIFIED LESION IN THE DISTAL OBTUSE MARGINAL VESSEL. PRE-DILATATION WAS PERFORMED. A 2.0 X 23 MINI VISION, A 2.25 X 12 MINI VISION, AND A 2.0 X 8 MINI VISION WERE ALL ATTEMPTED; HOWEVER, THE STENTS DID NOT CROSS THE LESION. SUBSEQUENT INFORMATION REPORTED THAT THE 2.0 X 8 MINI VISION STENT DISLODGED ONTO THE SHAFT DURING USE. THE STENT DELIVERY SYSTEM WAS REMOVED WITH THE STENT STILL LOCATED ON THE SHAFT. IT WAS ALSO NOTED THAT THERE WAS A BURR ON THE STENT. THE PROCEDURE WAS COMPLETED WITH BALLOONING ONLY. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. 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 9091641

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR