BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXTOME OTW CUTTING BALLOON

    MDR report key: 1283588 · Received January 8, 2009

    Report

    Report Number
    2134265-2009-00061
    Event Type
    Death
    Date Received
    January 8, 2009
    Date of Event
    December 10, 2008
    Report Date
    December 11, 2008
    Manufacturer
    BSC LETTERKENNY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS #2134265-2009-00062, 00063, 00064. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A THROMBOSIS AND DEATH OCCURRED. THE PATIENT PRESENTED TO THE CCL IN STABLE CONDITION. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A RUNWAY GUIDE CATHETER WAS PLACED AND THE LESION WAS PREDILATED; MULTIPLE INFLATIONS WERE MADE THROUGHOUT DIFFERENT AREAS OF THE LAD. IVUS WAS USED TO VISUALIZE THE VESSEL. A BUDDY WIRE WAS PLACED AND TWO INFLATIONS WERE MADE, INSIDE A PREVIOUSLY IMPLANTED STENT, WITH A FLEXTOME CUTTING BALLOON. AS THE CUTTING BALLOON WAS REMOVED, THE WIRE POSITION WAS LOST. IT TOOK ABOUT 20 MINUTES TO GET A CHOICE FLOPPY WIRE PLACED. THE PHYSICIAN THEN OPTED TO PLACE A 3.5X23MM PROMUS STENT, BUT BEFORE THE STENT WAS DEPLOYED, THE LEFT MAIN (LM) WAS NOTED TO BE "COMPLETELY CUT OFF" AND THROMBUS WAS NOTED THROUGHOUT THE LAD AND IN THE (LM). ANOTHER BALLOON WAS USED IN THE LM AND AN ASPIRATION CATHETER WAS USED TO EXTRACT THE THROMBUS. A TEMPORARY PACEMAKER HAD BEEN PLACED AND THE PATIENT WAS HAVING EPISODES OF VENTRICULAR FIBRILLATION. A 3.5X12MM NON-BSC STENT WAS PLACED IN AN ATTEMPT TO OPEN THE LM. INTEGRILIN AND "OTHER CODE BLUE DRUGS" WERE USED, HOWEVER THE PATIENT EXPIRED. A MAILMAN 300CM J TIP GUIDE WIRE WAS ALSO USED DURING THE PROCEDURE. THE RELATIONSHIP OF THE DEVICES TO THE REPORTED EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTOME OTW CUTTING BALLOON LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BSC LETTERKENNY CBO335015 EJ5353

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death