BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 2001461 · Received February 25, 2011

    Report

    Report Number
    2024168-2011-01187
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    January 25, 2011
    Report Date
    February 1, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO: PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE AND ACCESSORY DEVICE SUPPORT. IT IS LIKELY THAT INTERACTION WITH THE PREVIOUSLY IMPLANTED STENT CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE. ADDITIONALLY, AN INTERACTION WITH THE LESION/ANATOMY AND DEPLOYED STENT 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. SUBSEQUENT INTERACTION WITH THE DEPLOYED STENT DURING RETRACTION WOULD HAVE THEN LED TO THE REPORTED RESISTANCE AND ULTIMATELY THE STENT DISLODGEMENT. THE PATIENT WAS SENT TO SURGERY TO RETRIEVE THE DISLODGED STENT. IT SHOULD BE NOTED THE RX MINI VISIONS INSTRUCTIONS FOR USE (IFU) STATES: WHEN TREATING MULTIPLE LESIONS, STENT THE DISTAL LESION PRIOR TO STENTING THE PROXIMAL LESION. STENTING IN THIS ORDER OBVIATES THE NEED TO CROSS THE PROXIMAL STENT IN PLACEMENT OF THE DISTAL STENT, AND REDUCES THE CHANCE OF DISLODGING THE PROXIMAL STENT. 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. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS INVESTIGATION. THE REPORTED FAILURE TO ADVANCE, DIFFICULTY REMOVING THE SDS, AND STENT DISLODGEMENT APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PRE-DILATATION, A 2.25 X 15MM MINI VISION WAS DEPLOYED IN THE MID RIGHT CORONARY ARTERY (RCA). THE 2.25 X 08MM MINI VISION WAS THEN ADVANCED TO BE DEPLOYED DISTAL TO THE PREVIOUSLY IMPLANTED STENT; HOWEVER, THE STENT DELIVERY SYSTEM (SDS) WOULD NOT CROSS THE LESION AND DURING THE WITHDRAWAL, RESISTANCE WAS NOTED INSIDE THE DEPLOYED STENT. WHEN THE SDS WAS REMOVED, THE STENT WAS OBSERVED TO HAVE DISLODGED AND IT COULD BE SEEN ON ANGIOGRAPHY INSIDE THE DEPLOYED STENT. SURGERY WAS REQUIRED TO SUCCESSFULLY REMOVE THE DISLODGED STENT. THE PATIENT WAS IN STABLE CONDITION.

    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 9031241

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STENT: 2.25 X 15MM MINI VISION