BEUDAMED
    FDA Adverse Event Death Summary report: N

    CASHMERE 14 - PLATINUM MICROCOIL

    MDR report key: 2746035 · Received September 14, 2012

    Report

    Report Number
    2954740-2012-00699
    Event Type
    Death
    Date Received
    September 14, 2012
    Date of Event
    July 13, 2012
    Report Date
    August 16, 2012
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K072173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS, AND ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. PLEASE NOTE THAT THE ACTUAL PRODUCT CATALOG AND LOT NUMBER ARE UNKNOWN, THEREFORE THE PRODUCT REPRESENTS AN UNKNOWN CASHMERE COIL. THIS IS ONE OF MULTIPLE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT, WHICH IS ASSOCIATED WITH MFG REPORT 2954740-2012-00649 AND 2954740-2012-00699.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT AFTER RECEIPT OF ADDITIONAL INFORMATION, THE EVENT DOES NOT MEET THE CRITERIA FOR REPORTING. THEREFORE, NO FURTHER INFORMATION WILL BE FORTHCOMING FOR THIS MED WATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CASHMERE 14 PLATINUM MICROCOIL 3 MM X 4 CM (B)(4) DIDN'T DETACH, AND AFTER THE COILING PROCEDURE EVERYTHING WAS FINE. HOWEVER, 14 DAYS AFTER THE PROCEDURE, WHILE THE PATIENT REMAINED HOSPITALIZED, DIED OF A STROKE. THE EVENT WAS NOT RELATED TO THE COILS, SINCE THE PATIENT HAD MULTIPLE STROKES IN BOTH HEMISPHERE VENTRICLES DUE TO VASCULAR SPASM FOLLOWING THE SAB IN THE COURSE OF 7 DAYS AFTER THE PROCEDURE. THE VASOSPASM WAS CONFIRMED VIA TRANSCRANIAL DOPPLER ULTRA-SONOGRAPHY. NO ANGIOGRAMS WERE TAKING DURING THE STROKE. AFTER THE CASHMERE DEVICE WAS NOT IMPLANTED, A CASHMERE 14 PLATINUM MICROCOIL 3 MM X 4 CM ((B)(4)/LOT UNK) WAS USE TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO OTHER DEVICE WAS IMPLANTED IN THE PATIENT. THE MICROCOIL SYSTEM WAS NOT TESTED FOR PROPER FUNCTION WITH THE DETACHMENT CONTROL BOX BEFORE USE, AND THE DETACHMENT BUTTON WAS PRESSED THREE TIMES, AND NO PROBLEMS WERE OBSERVED WITH THE DCB OR CABLE ((B)(46) EMPOWER AND CONTROL BOX (B)(4) CABLE). AFTER THE EVENT, THE SAME DCB AND CABLE WERE USED FOR ALL OTHER COILS. THERE WAS NO STRETCHING OR UNINTENDED DETACHMENT THAT OCCURRED DURING THE PROCESS OF WITHDRAWAL, AND AFTER THE EVENT, THE COIL, DELIVERY SYSTEM OR INTRODUCER WERE NOT DAMAGED (UNRAVELED, STRETCHED, KINK, BEND, FRACTURE, ETC). THE COIL REMAINED ATTACHED TO THE DELIVERY SYSTEM. THE TARGET SITE WAS THE ACOM ARTERY WITH A BERRY SHAPED ANEURYSM MEASURING 7MMX4MM. NO FURTHER INFORMATION WAS AVAILABLE. THE PATIENT'S MEDICAL HISTORY CONSISTED OF ARTERIAL HYPERTENSION AND NO HYPERCOAGULATION WAS REPORTED. NO PATIENT HARM WAS REPORTED DURING THE PROCEDURE AND THE PRODUCT WILL BE RETUNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASHMERE 14 - PLATINUM MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death DCB