BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTAPLUSH - PLATINUM MICROCOIL

    MDR report key: 3231084 · Received July 17, 2013

    Report

    Report Number
    1226348-2013-20129
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 26, 2013
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K083646
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED AND THERE WAS NO STERILE LOT NUMBER INFORMATION AVAILABLE THUS NO DHR COULD BE PERFORMED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    POST PROCEDURE IMAGES SHOWING POSITION OF COIL DOES NOT PROVIDE INFORMATION REGARDING FACTORS CONTRIBUTING TO OR ROOT CAUSE OF THE DETACHMENT DIFFICULTIES. CORRECTED DATA: ALTHOUGH THE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED, AS REPORTED, IT APPEARS THAT DEVICE INTERACTION CONTRIBUTED TO THE EVENT. WITH REVIEW OF THE AVAILABLE INFORMATION, THERE IS NO INDICATION OF A RELATIONSHIP TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DURING THE COILING PROCEDURE TO TREAT AN UNRUPTURED ANEURYSM IN THE LEFT SUPERIOR CEREBELLAR ARTERY (LSCA), THE FIRST DELTAPLUSH PLATINUM MICROCOIL (DPL10030620/ UNK-POSSIBLY G13655) WOULD NOT DETACHED, BUT IT DETACHED AFTER A NEW DETACHMENT ENPOWER CABLE (ECB00018200/LOT UNK) AND LATER ON ANOTHER ENPOWER CONTROL BOX (DCB00000500/ F56896 & LOTNR: F39764) IT WORKED (THE LIGHT ON THE ENPOWER WAS GREEN). ADDITIONALLY, THE FIRST COIL WAS REPOSITIONED FEW TIMES (AROUND 5 TIMES) DURING THE EVENT. THE SAME PROBLEM OCCURRED WITH THE SECOND DELTAPLUSH PLATINUM MICROCOIL (DPL100304-20/UNK-POSSIBLE LOT G1635), BUT NO DETACHMENT WAS POSSIBLE, AND A NEW ENPOWER BOX AND DETACHMENT CABLE WERE USED. HOWEVER, THE PHYSICIAN FELT THAT THE COIL BROKE, AND THOUGHT IT WAS IN THE ANEURYSM, BUT LATER ON THE CT SHOWED THE 2ND COIL WAS STRETCHED IN THE VERTEBROBASILAR SYSTEM (SEE PICTURE). DURING THIS EVENT, IT WAS NOTED THAT THERE SOME ATTEMPTS WERE MADE TO DETACH THE COIL MANUALLY BY GOING A LITTLE BIT UP AND DOWN (TRIED IT ON THE MARKER, IN FRONT OF THE MARKER), BUT CONTINUE TO TRY WITH THE DCB. THE PATIENT HAD TO TAKE ASCAL AND REOPRO. PATIENT HAD DIFFICULTY WITH SPEECH (DYSARTHRIA) FOR ONE DAY, NOW THE PATIENT IS RECOVERED. PRIOR TO THE EVENT, AN SL-10 MICROCATHETER WAS USED ALONG WITH COSMOS COILS 1X 8MMX37CM, 2X 7MMX31CM, AND DELTAPAQ 5MMX15CM, 2X 3MMX8CM X2. BOTH DEVICES REMAIN IMPLANTED AND WILL NOT BE RETURN FOR ANALYSES. PRIOR TO THE EVENT, AN SL-10 MICROCATHETER (INNER DIAMETER 0,0165¿ COMPARABLE TO THE PROWLER SELECT PLUS MICROCATHETER) WAS USED ALONG WITH COSMOS COILS 1X 8MMX37CM, 2X 7MMX31CM, AND DELTAPAQ 5MMX15CM, 2X 3MMX8CM X2. BOTH DEVICES REMAIN IMPLANTED AND WILL NOT BE RETURNED FOR ANALYSES. THE LOT NUMBERS OF THE DETACHMENT CABLES WERE UNKNOWN BECAUSE THEY WERE THROWN AWAY RIGHT AFTER THE EVENT WAS REPORTED. THE LOT NUMBERS PROVIDED FOR THE COILS WERE CONFIRMED. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS NOT PERFORMED PRIOR TO INSERTING IN THE PATIENT, AND DURING THE GREEN LIGHT WAS ON. THE AUDIBLE SIGNAL DID NOT BEEP DURING THE LAST DETACHMENT BECAUSE IT DIDN'T DETACHED, AND ALL CONNECTIONS APPEAR TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE SAME DCBS USED SUCCESSFULLY WITH SUBSEQUENT COILS AND PROCEDURES, AND NO RESISTANCE OCCURRED DURING INSERTION, ADVANCEMENT, POSITIONING, OR REMOVAL OF THE COIL DELIVERY SYSTEM (THE WHOLE PROCEDURE WENT SMOOTH AS IT SUPPOSED TO GO). MEDICATION GIVEN PRIOR TO THE EVENT CONSISTED OF HEPARIN AT START 3000 UNITS AND FOLLOWED BY 2000 UNITS EVERY HOUR, AND THE PT, PTT, INR, ETC WERE NOT MEASURED. THE ANEURYSM WAS PARTIALLY THROMBOSED BUT THE REASON WHY THEY TREATED THE PATIENT WAS BECAUSE OF THE INCREASING COMPRESSION AT THE BRAIN STEM. NO FURTHER INFORMATION WAS AVAILABLE. THE DEVICE REMAINS IMPLANTED AND THE LOT NUMBER PROVIDED COULD NOT BE CONFIRMED. THEREFORE, NO DHR COULD BE CONDUCTED. ALTHOUGH THE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED, AS REPORTED, IT APPEARS THAT DEVICE INTERACTION CONTRIBUTED TO THE EVENT. WITH REVIEW OF THE AVAILABLE INFORMATION, THE ANALYSIS OF THE RETURNED DEVICE AND THE DEVICE HISTORY RECORDS THERE IS NO INDICATION OF A RELATIONSHIP TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING THE COILING PROCEDURE TO TREAT AN UNRUPTURED ANEURYSM IN THE LEFT SCA, THE FIRST DELTAPLUSH PLATINUM MICROCOIL (DPL10030620/ UNK-POSSIBLY G13655) WOULD NOT DETACHED, BUT AFTER A FEW (AROUND 5 TIMES) REPOSITIONING IT DETACHED (THE LIGHT ON THE ENPOWER WAS GREEN). THE SAME PROBLEM OCCURRED WITH THE SECOND DELTAPLUSH PLATINUM MICROCOIL (DPL100304-20/UNK-POSSIBLE LOT G1635). NO DETACHMENT POSSIBLE, AND TRIED A NEW ENPOWER BOX AND DETACHMENT CABLE. HOWEVER, THE PHYSICIAN FELT THAT THE COIL BROKE, AND THOUGHT IT WAS IN THE ANEURYSM, BUT LATER ON THE CT SHOWED THE 2ND COIL WAS STRETCHED IN THE VERTEBROBASILAR SYSTEM. THE PATIENT HAD TO TAKE ASCAL AND REOPRO. PATIENT HAD DIFFICULT WITH SPEECH (DYSARTHRIA) FOR ONE DAY, NOW THE PATIENT IS RECOVERED. PRIOR TO THE EVENT, AN SL-10 MICROCATHETER WAS USED ALONG WITH COSMOS COILS 1X 8MMX37CM, 2X 7MMX31CM, AND DELTAPAQ 5MMX15CM, 2X 3MMX8CM X2. BOTH DEVICES REMAIN IMPLANTED AND WILL NOT BE RETURN FOR ANALYSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331134 DELTAPLUSH - PLATINUM MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention UNK SL-10 MICROCATHETER