BEUDAMED
    FDA Adverse Event Summary report: N

    GUIDANT INSIGNIA

    MDR report key: 2993998 · Received March 4, 2013

    Report

    Report Number
    2993998
    Date Received
    March 4, 2013
    Date of Event
    February 21, 2013
    Report Date
    March 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LWP
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS SCHEDULED FOR A TRANSAPICAL APPROACH AORTIC VALVE REPLACEMENT. WHEN MOVING THE PATIENT ON A SLIDER BOARD FROM STRETCHER TO THE OPERATING ROOM (OR) TABLE, THE PATIENT'S HEART RATE INCREASED TO 130 BEATS PER MINUTE (BPM). THE PATIENT'S HEART RATE WAS IN THE 80'S WHEN SEEN IN THE PRE OPERATING ROOM JUST PREVIOUSLY. THE PATIENT HAS A PERMANENT PACEMAKER IN PLACE. WE WERE UNABLE TO REDUCE THE HEART RATE WITH MEDICATION FOLLOWING INTUBATION. THE PATIENT'S BLOOD PRESSURE DROPPED INTO THE 50'S. "CPR WAS PERFORMED FOR ABOUT ONE MINUTE. HEMODYNAMICALLY, THE PATIENT WAS STABILIZED WITH INOTROPIC THERAPY, BUT HIS HEART RATE REMAINED AT 130. HE WAS GIVEN BETA-BLOCKERS AND DESPITE BETA-BLOCKERS, HIS HEART RATE WOULD NOT SLOW DOWN. HIS EJECTION FRACTION ON TRANSESOPHAGEAL ECHOCARDIOGRAM WAS MARKEDLY DIMINISHED IN THE RANGE OF 20% TO 25%. THE RIGHT VENTRICULAR SYSTOLIC FUNCTION IS MARKEDLY DIMINISHED. WE HAD THE PACEMAKER INTERROGATED AND HE HAS A VVIR PACEMAKER IN PLACE... FOR UNCLEAR REASONS, THE PACEMAKER HAD SWITCHED OUT TO A RATE RESPONSE AT 130 AND DID NOT RESPOND TO THE PLACEMENT OF A MAGNET. REPRESENTATIVES OF BOSTON SCIENTIFIC READJUSTED THE PULSE GENERATOR AND WE SET THE LOWER RATE AT 80 BEATS PER MINUTE. UPON DOING THIS, THE PATIENT'S OVERALL EJECTION FRACTION DID IMPROVE, BUT TO 30-35%. HIS RIGHT VENTRICULAR CHAMBER DID REMAIN DILATED AND MODERATE TO SEVERELY DEPRESSED."..."IT IS UNCLEAR WHETHER THE PATIENT HAD ALREADY BEEN DECOMPENSATING, THUS HIS EJECTION FRACTION HAD DROPPED FROM 45% BY 2D ECHO DOPPLER PERFORMED TO THE CURRENT STATUS OF 20% TO 25% OR IF THIS WAS ASSOCIATED TO THE TACHYCARDIA THAT WAS TRIGGERED BY MALFUNCTION OF HIS PACEMAKER...IT WAS ELECTED TO PROCEED WITH TRANSFEMORAL AORTIC VALVULOPLASTY TO RESTABILIZE THIS PATIENT FOR SAFER TRANSAPICAL APPROACH IN THE ENSUING ONE TO TWO WEEKS." THE PATIENT WAS DISCHARGED HOME; DOING WELL WITH NO NEURO DEFICITS OR COMPLICATIONS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?TRANSAPICAL APPROACH AORTIC VALVE REPLACEMENT--NOT PERFORMED; AORTIC BALLOON VALVULOPLASTY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91415 GUIDANT INSIGNIA IMPLANTABLE LWP BOSTON SCIENTIFIC 1190 *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR