BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROVENTION

    MDR report key: 379270 · Received February 25, 2002

    Report

    Report Number
    MW1024203
    Event Type
    Injury
    Date Received
    February 25, 2002
    Date of Event
    February 18, 2002
    Report Date
    February 25, 2002
    Manufacturer
    MICROVENTION
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 11/8/02: REPORT NO MW1024203 (MICRO VENTION REFERENCE 2032493-2002-00001) INVOLVED A PREMATURE DETACHMENT OF AN MCS 8-MM X 19-CM COMPLEX COIL. THE COIL WAS RETRIEVED WITH NO PT INJURY. THE EVENT OCCURRED DURING AN INITIAL EVALUATION PRIOR TO FULL MARKET LAUNCH. THE COIL COUPLER USED FOR THE PRODUCT INVOLVED IN THIS REPORT HAD A SMOOTH OUTER FINISH. DURING THE COMPLAINT EVALUATION, IT WAS NOTED THAT THE PREMATURE DETACHMENT ISSUE COULD BE DUPLICATED USING AN IN VITRO ANEURYSM MODEL AFTER MULTIPLE REPOSITIONS. THIS MODEL WAS FABRICATED FROM THE CASE ANGIOGRAMS AND REPLICATED THE ACTUAL ANATOMY OF THE PT. TENSILE TESTING COMBINED WITH FUNCTIONAL TESTING DEMONSTRATED A REDUCTION IN THE COIL ATTACHMENT TENSILE STRENGTH AFTER MULTIPLE REPOSITIONS. IT WAS DETERMINED THAT THE FAILURE MODE WAS A DE-COUPLING DUE TO REPOSITIONING FORCES EXCEEDING THE TENSILE STRENGTH OF THE DETACHMENT ZONE. IT WAS CONCLUDED THAT THE TENSILE STRENGTH ISSUES WERE CAUSED BY SMOOTH OUTER FINISH OF THE COUPLER. IT WAS ALSO CONCLUDED THAT TORTUOUS ANATOMY OF THE VASCULATURE CONTRIBUTED TO THE EVENT. TWO OTHER REPORTS WERE ALSO SUBMITTED FOR PREMATURE DETACHMENT (REFERENCE 2032493-2002-00002 AND 2032493-2002-00003). THESE EVENTS OCCURRED IN A FOREIGN COUNTRY ALSO DURING AN INITIAL EVALUATION. THE ROOT CAUSE OF THESE TWO REPORTS WAS DETERMINED TO BE THE SAME AS THE FIRST REPORT. AS A CORRECTIVE ACTION, A NEW SPIRAL DESIGN COUPLER WAS DEVELOPED THAT INCORPORATES TWO EXTERNAL GROOVES FOR INCREASED TENSILE STRENGTH. THE MINIMUM DETACHMENT ZONE TENSILE STRENGTH SPECIFICATION WAS INCREASED FROM A MINIMUM OF 0.017 POUNDS TO 0.1 POUNDS. IN-HOUSE PRODUCT BUILT WITH THE OLD COUPLER DESIGN WAS DESTROYED. THERE WAS NO PRODUT IN THE FILED WITH THE OLD COUPLER DESIGN SINCE THE PRODUCT HAD NOT YET BEEN LAUNCHED. THE NEW SPIRAL COUPLER WAS VALIDATED IN MARCH 2002 AND THE MCS WITH THE NEW COUPLER DESIGN WAS LAUNCHED IN APRIL 2002. THE SUBSEQUENT REPORTS PRIMARILY INVOLVED DIFFICULT OR NO DETACHMENTS AFTER MULTIPLE ATTEMPTS. IT WAS DETERMINED THAT THIS ISSUE WAS PRIMARILY RELATED TO THE 0.5-CC DETACHMENT SYRINGE AND PHYSICIAN TECHNIQUE. AS NOTED ABOVE, A NEW COUPLER, A NEW COUPLER DESIGN WAS IMPLEMENTED TO INCREASE THE TENSILE STRENGTH AND PREVENT PREMATURE DETACHMENT. IT WAS DETERMINED THAT THE 0.5-CC SYRINGE WAS NOT ADEQUATE FOR COIL DETACHMENT DUE TO THE INCREASED TENSILE STRENGTH. A NEW 0.25-CC SYRINGE WAS DEVELOPED AND IS CURRENTLY BEING IMPLEMENTED. A 510(K) FOR THE NEW SYRINGE WAS CLEARED ON SEPTEMBER 6, 2002 (REFERENCE K022735). PHYSICIAN TRAINING ON THE CORRECT DETACHMENT TECHNIQUE IS BEING CONDUCTED. ONGOING IMPROVEMENTS ARE ALSO BEING IMPLEMENTED IN THE MANUFACTURING PROCESS TO PREVENT VARIABILITY IN THE PET ATTACHMENT PROCESS AND WITH THE COUPLER SUPPLIER TO ENSURE CONSISTENT QUALITY.

    Description of Event or Problem · 1

    PREMATURE UNINTENDED DETACHMENT OF ANEURYSM EMBOLIZATION COIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROVENTION ANEURYSM DETACHABLE COIL HCG MICROVENTION 8MM X 19MM, 18 SERIES PO10266

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention