BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1121123 · Received August 14, 2008

    Report

    Report Number
    2024168-2008-00668
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 12, 2008
    Report Date
    July 15, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO DETERMINE A CONCLUSIVE ROOT CAUSE FOR THE STENT DISLODGEMENT. QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS NOT RETURNED. ONLY THE STENT IMPLANT ON THE STYLET WITH THE ORANGE PROTECTIVE SHEATH WAS RETURNED. THE STENT IMPLANT WAS RETURNED WITH NO BLOOD VISIBLE. THERE WAS NO CONTRAST VISIBLE. THERE WERE FIVE STRUTS IN THE FIRST ROW AND FOUR STRUTS IN THE SECOND ROW AT THE PROXIMAL END OF THE STENT IMPLANT THAT WERE CRUSHED. THERE WAS NO OTHER DAMAGE NOTED TO THE STENT IMPLANT. PIN GAUGES WERE USED TO MEASURE THE INNER DIAMETER OF THE ORANGE PROTECTIVE SHEATH. A SNAP GAUGE WAS USED TO MEASURE THE OUTER DIAMETER OF THE STENT IMPLANT. THE PROXIMAL OUTER DIAMETER OF THE STENT IMPLANT COULD NOT BE MEASURED DUE TO THE DAMAGE NOTED. THE DISTAL AND MIDDLE OUTER DIAMETER MEASUREMENTS MET MANUFACTURING CRITERIA. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND THE RESULTS OF THE RETURNED STENT IMPLANT AND PROTECTIVE SHEATH ANALYSIS. THE ANALYSIS OF THE RETURNED STENT IMPLANT AND PROTECTIVE SHEATH, WITHOUT BLOOD OR CONTRAST CONFIRMED THE REPORTED COMPLAINT OF STENT DISLODGEMENT OUTSIDE THE BODY. THE SDS OF THE RX VISION WAS NOT RETURNED AND IT WAS NOT POSSIBLE TO ASCERTAIN THAT THE STENT IMPLANT WAS ORIGINALLY CRIMPED ONTO THE BALLOON DURING MANUFACTURING. HOWEVER, IT SHOULD BE NOTED THAT ALL SDS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT/SECURITY, STENT DAMAGE AND DIMENSIONALLY INSPECTED TO VERIFY CRIMPED STENT OUTER DIAMETERS. FACTORS THAT CAN AFFECT STENT DISLODGEMENT OUTSIDE THE BODY INCLUDE, BUT ARE NOT LIMITED TO, POSITIVE PRESSURE DURING PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL OR IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURING. THE NOTED SMASHED STENT STRUTS AT THE PROXIMAL END OF THE STENT IMPLANT SUGGEST THAT THE PROTECTIVE SHEATH MAY HAVE BEEN FORCEFULLY REMOVED OR SOME FEATURE OF THE PROTECTIVE SHEATH CAUGHT THE STRUT AND CAUSED THE DAMAGE DURING THE REMOVAL OR THAT THE STENT WAS HANDLED AFTER THE DISLODGEMENT LEADING TO UNINTENDED DAMAGE. THE INNER DIAMETER OF THE PROTECTIVE SHEATH WAS FOUND TO BE WITHIN MANUFACTURING CRITERIA. ALSO THE OUTER DIAMETERS OF THE UNDAMAGED PORTION OF THE STENT IMPLANT (MIDDLE & DISTAL) MET MANUFACTURING CRITERIA. BASED ON THE INCIDENT INFORMATION AND RESULTS OF THE ANALYSIS OF THE RETURNED SDS, A CONCLUSIVE ROOT CAUSED FOR THE REPORTED STENT DISLODGEMENT CANNOT BE DETERMINED. HOWEVER, THERE IS NO INDICATION TO SUGGEST THAT MATERIALS OR WORKMANSHIP MAY HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. A REVIEW OF THE LOT HISTORY RECORD DID INDICATE ANY NON-CONFORMING MATERIAL REPORTS. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAS PREVIOUSLY CAUSED OR CONTRIBUTED TO PATIENT INJURY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE STENT DISLODGED ON THE STYLET WHEN THE PROTECTIVE SHEATH WAS REMOVED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM 74MAF MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 8010831

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK