BEUDAMED
    FDA Adverse Event Death Summary report: N

    THE CLOSER S 6 FR SMC

    MDR report key: 469864 · Received July 3, 2003

    Report

    Report Number
    2953144-2003-00144
    Event Type
    Death
    Date Received
    July 3, 2003
    Date of Event
    June 19, 2001
    Report Date
    June 11, 2003
    Manufacturer
    PERCLOSE, INC.
    Product Code
    MGB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PT PRESENTED TO THE E.R. IN "2002" WITH COMPLAINTS OF EPIGASTRIC PAIN, NAUSEA, VOMITING, SWEATING AND SHORTNESS OF BREATH. BLOOD WORK AND EKG WERE PERFORMED. A DIAGNOSIS OF ACUTE INFERIOR WALL MI WAS MADE AND THE PT WAS ADMITTED TO THE ICU. THE PT UNDERWENT A CARDIAC CATHETERIZATION IN 2001. THE CIRCUMFLEX ARTERY WAS FOUND TO HAVE TWO LESIONS, ONE 70% AND THE OTHER 90%. THE LESIONS WERE TREATED WITH STENTS. TWO CLOSER S DEVICES WERE USED. THE FIRST CLOSER S WAS REPORTED TO "FAIL". THE SECOND CLOSER S DEVICE WAS REPORTED TO BE INSERTED AND DEPLOYED. THE PROCEDURE BEGAN AT 1323 AND ENDED AT 1438. THE PT RETURNED TO THE ICU AT 1500. "SHORTLY" AFTER RETURNING TO THE ICU, THE NURSE ASSESSED A DROP IN THE PT'S BLOOD PRESSURE. A "SHORT" TIME LATER THE PT BECAME RESTLESS, AGITATED AND COMPLAINED OF SEVERE NAUSEA AND BACK PAIN. THE CARDIOLOGIST WAS NOTIFIED AND CONSULTED WITH A PULMONOLOGIST/CRITICAL CARE SPECIALIST. BOTH OF THE PHYSICIANS PROVIDED MEDICAL DIAGNOSIS, CARE AND TREATMENT OF THE PT IN THE ICU FOLLOWING THE CARDIAC CATHETERIZATION PROCEDURE. AT 1700, THE PT WAS FOUND TO HAVE NO PALPABLE PULSE AND CARDIAC MONITOR SHOWED PULSELESS ELECTRICAL ACTIVITY. RESUSCITATION EFFORTS WERE UNSUCCESSFUL AND THE PT WAS PRONOUNCED DEAD AT 1715.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE CLOSER S 6 FR SMC SUTURE MEDIATED CLOSURE MGB PERCLOSE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death UNSPECIFIED CORONARY ARTERY STENTS.