BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 1913067 · Received December 2, 2010

    Report

    Report Number
    2024168-2010-02578
    Event Type
    Injury
    Date Received
    December 2, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    AV-CLONMEL
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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. REINSERTION. FAILURE TO ADVANCE/PHYSICAL RESISTANCE WHEN ATTEMPTING TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, PRODUCT PLACEMENT TECHNIQUE, PRODUCT SIZE SELECTION AND ACCESSORY PRODUCT SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, HANDLING, LESION CALCIFICATION AND TORTUOSITY, AN INTERACTION WITH A PREVIOUSLY IMPLANTED STENT, INSUFFICIENT PREPARATION PRIOR TO USE OR FROM INTERACTIONS WITH OTHER DEVICES. SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS MAY INDICATE THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. IF THE BALLOON EXPERIENCES MECHANICAL DAMAGE AT SOME POINT DURING THE PROCEDURE, THIS CAN CAUSE THE MATERIAL TO WEAKEN AND RUPTURE DURING AN ATTEMPT TO INFLATE THE CATHETER. IN THIS CASE, IT WAS REPORTED THE PATIENT ANATOMY WAS HEAVILY TORTUOUS AND MODERATELY CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE REPORTED BALLOON RUPTURE. ADDITIONALLY, IT WAS REPORTED THE MINI VISION SDS FAILED TO CROSS THE LESION, WAS REMOVED, AND THEN RE-INSERTED INTO THE PATIENT ANATOMY. IT SHOULD BE NOTED THE MINI VISION INSTRUCTIONS FOR USE (IFU) STATES: AN UNEXPANDED STENT MAY BE RETRACTED INTO THE GUIDING CATHETER ONE TIME ONLY. SUBSEQUENT MOVEMENT IN AND OUT THROUGH THE DISTAL END OF THE GUIDING CATHETER SHOULD NOT BE PERFORMED AS THE STENT MAY BE DAMAGED WHEN RETRACTING THE UNDEPLOYED STENT BACK INTO THE GUIDING CATHETER. THE MOVEMENT IN AND OUT OF THE GUIDING CATHETER COULD HAVE CAUSED DAMAGE TO THE STENT, THEREFORE ADDITIONALLY CONTRIBUTING TO THE BALLOON RUPTURE. FURTHER, AS THE BALLOON RUPTURE OCCURRED DURING INFLATION OF THE STENT, IT IS LIKELY THAT THE STENT WAS NOT FULLY DEPLOYED; THEREFORE RESULTING IN THE STENT BEING PULLED BACK INTO THE PROXIMAL RCA DURING RETRACTION OF THE SDS. ADDITIONAL THERAPY WAS USED TO DEPLOY THE STENT IN THE PROXIMAL RCA WITH ANOTHER BALLOON. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS FOR THIS LOT DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS EVENT. IN THIS CASE, THE REPORTED PHYSICAL RESISTANCE, BALLOON RUPTURE, AND STENT DISLODGEMENT APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MID AND PROXIMAL RIGHT CORONARY ARTERY (PRCA, MRCA) STENTING PROCEDURE, IN A MODERATELY CALCIFIED / HEAVILY TORTUOUS VESSEL, AFTER PRE-DILATATION, THE 2.5X15MM MINI VISION STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND THE BMW UNIVERSAL WIRE WAS EXCHANGED FOR A PILOT 50 WIRE. THE 2.5X15MM MINI VISION WAS THEN REINSERTED AND SUCCESSFULLY CROSSED THE LESION; HOWEVER, THE BALLOON RUPTURED AT 12 ATMOSPHERES (ATM) DURING ATTEMPTED DEPLOYMENT. UPON REMOVAL OF THE SDS, THE STENT WAS PULLED BACK INTO THE PRCA. A 3.0X20MM NON-ABBOTT BALLOON SUCCESSFULLY DEPLOYED THE STENT IN THE PRCA. THERE WAS NO ADVERSE PATIENT SEQUELA. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION 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-CLONMEL 0081941

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention BMW & PILOT GUIDE WIRESMEDRONIX 6F GUIDE CATHETE