BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 1854418 · Received September 30, 2010

    Report

    Report Number
    2024168-2010-02038
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    September 5, 2010
    Report Date
    September 7, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: EVAL OF THE RETURNED MINI VISIONS STENT DELIVERY SYS (SDS) NOTED DRIED BLOOD AND CONTRAST VISIBLE ON THE SHAFT, WHICH IS CONSISTENT WITH HANDLING. THE STENT HAD DISLODGED FROM THE BALLOON AND WAS NOT RETURNED, CONFIRMING THE REPORTED INFO. 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 MFR. 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 SDS, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, OR HANDLING OF THE STENT DURING DEVICE PREPARATION. IT WAS REPORTED THE STENT WAS INADVERTENTLY HANDLED DURING REMOVAL OF THE PROTECTIVE SHEATH, RESULTING IN THE STENT DISLODGING FROM THE BALLOON. IT SHOULD BE NOTED IN THE MINI VISION INSTRUCTIONS FOR USE (IFU) IT STATES: SPECIAL CARE MUST BE TAKEN NOT TO HANDLE OR IN ANY WAY DISRUPT THE STENT ON THE BALLOON. THIS IS MOST IMPORTANT DURING CATHETER REMOVAL FROM PACKAGING, PLACEMENT OVER GUIDE WIRE AND ADVANCEMENT THROUGH ROTATING HEMOSTATIC VALVE ADAPTER AND GUIDING CATHETER HUB. RETURN OF THE STENT AND PROTECTIVE SHEATH MAY HAVE AIDED THE EVAL. ANALYSIS NOTED THE PROXIMAL BALLOON TAPER WAS BUNCHED AND THERE WAS BALLOON SHREDDING ON THE PROXIMAL AND DISTAL BALLOON TAPERS, WHICH WAS NOT INITIALLY REPORTED WITH THE INCIDENT INFO. THE BALLOON PEELING APPEARS TO BE THE RESULT OF THE PROCEDURE CIRCUMSTANCES, AS THERE WAS NO REPORT OF ANY DAMAGE TO THE BALLOON DURING VISUAL INSPECTION OR PREPARATION OF THE PRODUCT PRIOR TO THE PROCEDURE. ALTHOUGH BALLOON PEELING OR SHREDDING IS OCCASIONALLY SEEN ON MFG PRODUCTION LINES, IT IS MORE LIKELY THAT THE BALLOON PEELING OCCURRED DURING HANDLING OF THE SDS. ANALYSIS NOTED MULTIPLE BENDS AND KINKS THROUGHOUT THE SDS AND THE TIP OF THE SDS WAS SLIGHTLY FLARED. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFO, THE BENDS, KINKS, AND FLARED TIP MAY HAVE OCCURRED DURING THE PROCEDURE OR 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. A REVIEW OF THE PRODUCT MFG 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 MFG CRITERIA. THE REPORTED STENT DISLODGEMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. ALL STENT DELIVERY SYSTEMS ARE 100% 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 A PT WAS BEING TREATED FOR A DISSECTION IN THE HEAVILY CALCIFIED MID RIGHT CORONARY ARTERY WHEN THE 2.5 X 18 MINI VISION WAS UNABLE TO CROSS THE LESION. THE CAUSE OF THE DISSECTION IS UNK, BUT WAS NOT CAUSED BY THE MINI VISION STENT. A 2.0 X 8 MINI VISION WAS OPENED, BUT DURING PREPARATION, THE STENT WAS NOT FOUND ON THE DELIVERY SYS. IT IS SURMISED THAT THE CAUSE OF THE STENT DISLODGEMENT WAS IMPROPER REMOVAL OF THE STENT COVER DURING PREPARATION. THERE WAS NO PT INVOLVEMENT. THE PT WAS TAKEN TO SURGERY FOR TREATMENT OF THE DISSECTION. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFO PROVIDED. DURING RETURN DEVICE ANALYSIS, BALLOON SHREDDING WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 9101541

    Patients

    Seq Age Sex Outcome Treatment
    1 NA