BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAVERICK OTW

    MDR report key: 897087 · Received August 14, 2007

    Report

    Report Number
    6000093-2007-01528
    Event Type
    Injury
    Date Received
    August 14, 2007
    Date of Event
    November 2, 2006
    Report Date
    July 20, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    LOX
    PMA / PMN Number
    K934378
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    CLINICAL TRIAL. IT WAS REPORTED THAT DURING A CORONARY INTERVENTION PROCEDURE, THE MAVERICK BALLOON BURST CAUSING A DISSECTION. ACCESS WAS GAINED THROUGH A SHORT, 6F SHEATH IN A RETROGRADE FASHION IN THE RIGHT COMMON FEMORAL ARTERY AND A 6F Q-4 GUIDING CATHETER WAS PLACED IN THE OSTIUM OF THE LMCA (LEFT MAIN CORONARY ARTERY). BALLOON ANGIOPLASTY WAS PERFORMED ON THE PREVIOUSLY PLACED STENT IN THE LMCA TO RAMUS AND RESOLVED AFTER SEVERAL INFLATIONS. THEN THE PHYSICIAN FELT THAT THE PROXIMAL CX (CIRCUMFLEX) ALSO NEEDED REVASCULARIZATION. THE PREVIOUSLY PLACED STENT IN THE DISTAL LMCA TO RAMUS WAS FURTHER DILATED WITH A 1.5 MIDDLE MARKET MAVERICK BALLOON. THIS BALLOON WAS ALSO USED TO DILATE THE 80% LESION OF THE MID CX AND WAS THEN REMOVED. THEN THIS 2.5X15MM MAVERICK BALLOON CROSSED THE PREVIOUSLY PLACED STENT STRUTS AND INTO THE PROXIMAL CX. THE BALLOON WAS INFLATED TO 8 ATMS AND RUPTURED CAUSING A DISSECTION OF THE LMCA. THE BALLOON WAS REMOVED AND A 3.5X16MM TAXUS STENT WAS DEPLOYED CROSS THE LMCA DISSECTION AND INTO THE RAMUS, OVERLAPPING THE PREVIOUSLY PLACED STENT. THIS RESULTED IN EXCELLENT FLOW INTO THE RAMUS AND INTO THE CX. ADDITIONAL POSTDILATION OF THE STENT OVERLAP AREA WAS PERFORMED WITH THE DELIVERY BALLOON FROM THE TAXUS STENT. THE FINAL RESULT WAS EXCELLENT WITH GREAT FLOW INTO THE RAMUS AND INTO THE DISTAL CX BED. THE PT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE WITHOUT ANY EKG, CLINICAL, OR OTHER ANGIOGRAPHIC EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK OTW LOX - CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORP. 2.5X15MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention