BEUDAMED
    FDA Adverse Event Death Summary report: N

    BOSTON SCIENTIFIC ULTRA2

    MDR report key: 831938 · Received March 22, 2007

    Report

    Report Number
    831938
    Event Type
    Death
    Date Received
    March 22, 2007
    Date of Event
    February 15, 2007
    Report Date
    March 20, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A PT WITH PROGRESSIVE LV DYSFUNCTION AND FAILURE WITH AORTIC STENOSIS. THE AVA WAS 0.7 BY ECHO. PAV WAS PERFORMED AFTER CORONARY ANGIO DEMONSTRATED SEVERE PROXIMAL LAD STENOSIS WITH DENSE CALCIFICATION AND SEVERE FOCAL MID RCA LESION. PAV BROUGHT AVA TO 0.9 AND OUTPUT INCREASED. THE LAD DILATION WAS ATTEMPTED WITH A HIGH PRESSURE BALLOON. THE STENOSIS RESISTED DILATION. A CUTTING BALLOON WAS PASSED WITH FORCE AND THE TIP APPEARED TO ENTER THE STENOSIS. BLOOD WAS SEEN IN THE BALLOON CATHETER SHAFT INDICATING RUPTURE AND THE CATHETER WAS PULLED BACK WITHOUT INFLATION. THE TIP INCLUDING THE DISTAL MARKER REMAINED IN THE LAD. ANTERIOR FLOW WAS THEN REDUCED AND THE PT BECAME UNSTABLE. DURING ATTEMPTS TO OPEN THE PROXIMAL LAD BY PASSING A BALLOON BESIDE THE RESIDUAL CATHETER FRAGMENT, THE DISTAL FRAGMENT EMBOLIZED TO THE DISTAL CX AND THE LAD WAS DISSECTED. STENTS WERE THEN PLACED IN THE DISSECTION CHANNEL WHICH REENTERED IN THE DISTAL LAD, FLOW WAS RESTORED WITH PERFUSION OF SEVERAL DIAGONAL BRANCHES AS WELL AS THE DISTAL LAD. NEVERTHELESS, THE PT REMAINED INTUBATED WITH PULMONARY EDEMA AND PNEUMONIA AND DIED 10 DAYS AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC ULTRA2 CUTTING BALLOON 2.75X10MM LIT BOSTON SCIENTIFIC * EG0949

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death