BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    MDR report key: 1081594 · Received July 25, 2008

    Report

    Report Number
    2024168-2008-00605
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 25, 2008
    Manufacturer
    ABBOTT VASCULAR - CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - IT IS POSSIBLE THAT WHILE ATTEMPTING TO CROSS THE LESION IN THE VEIN GRAFT, THE STENT BECAME DISRUPTED ON THE BALLOON AND FACILITATED THE DISLODGEMENT OF THE STENT; IN THIS INSTANCE, THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE ULTIMATE ROOT CAUSE OF THE STENT DISLODGEMENT IS UNKNOWN, BUT INTERACTION WITH THE GUIDE CATHETER TIP DURING REMOVAL AFTER THE FAILED ATTEMPT TO CROSS AND THE PATIENT ANATOMICAL MORPHOLOGY DURING THE ATTEMPT TO CROSS ARE LIKELY CONTRIBUTING FACTORS. THE PATIENT EFFECT TO REMOVAL OF A FOREIGN BODY IS A RECOGNIZED PATIENT EFFECT ASSOCIATED WITH STENT DISLODGEMENT IN-VIVO AND WAS ADDRESSED IN THE RISK ASSESSMENT.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: REMOVAL OF A DISLODGED STENT FROM PATIENT. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN A VEIN GRAFT. AFTER PRE-DILATATION, THE 2.25 X 08 MM MINI VISION WAS ADVANCED, BUT WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED AND THE STENT WAS OBSERVED TO HAVE SOME DAMAGE. THEN THE 2.0 X 08 MM MINI VISION WAS ADVANCED, BUT IT TOO WAS UNABLE TO CROSS. WHEN IT WAS REMOVED, THE STENT WAS MISSING. USING ANGIOGRAPHY, THE STENT WAS LOCATED IN THE PROXIMAL PART OF THE GRAFT. AN ATTEMPT WAS MADE TO RETRIEVE THE STENT WITH A BALLOON, BUT WAS UNSUCCESSFUL. A GUIDE WIRE WAS ABLE TO SNARE AND REMOVE THE DISLODGED STENT FROM THE PATIENT. THERE WERE NO PATIENT EFFECTS. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM 74MAF MAF ABBOTT VASCULAR - CARDIAC THERAPIES NA 510103Q

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention STENT: 2.25 X 8 MM MINI VISION