BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTAPAQ - PLATINUM MICROCOIL

    MDR report key: 2587986 · Received May 24, 2012

    Report

    Report Number
    2954740-2012-00564
    Event Type
    Injury
    Date Received
    May 24, 2012
    Date of Event
    February 1, 2012
    Report Date
    April 7, 2012
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K080379
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF FIVE PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 2954740-2012-00560, 2954740-2012-00561, 2954740-2012-00562, 2954740-2012-00563 AND 2954740-2012-00564. THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA THE (B)(4) STUDY INDICATING THERE WAS INTRAPROCEDURAL THROMBUS FORMATION DURING TREATMENT OF A RUPTURED RIGHT INTERNAL CAROTID ARTERY (ICA) ANEURYSM USING THE FOLLOWING COILS: MICRUSPHERE 10 (SPH100600-20/LOT F42982), MICRUSPHERE 10 (SPH100500-20/LOT F68462), DELTAPAQ 10 (DFS100308-20/LOT G11538), DELTAPAQ 10 (DFS100306-20/LOT F47560), AND DELTAPAQ 10 (DFS100208-20/LOT G11340). ADDITIONAL INFORMATION WITH FOLLOW-UP INVESTIGATION REPORTED THAT THERE WAS GRADUAL COIL PROTRUSION ON THE ORDER OF 1MM. IT WAS NOTICED OVER TIME AS SUBSEQUENT COILS WERE PLACED. THERE IS NO DOCUMENTATION REGARDING WHICH COIL CAUSED IT; IT WAS THE COIL MASS, NOT A SPECIFIC COIL. THERE WAS NO COIL DAMAGE. MEDICAL INTERVENTION WAS REQUIRED WITH THE PATIENT'S CONDITION RETURNING TO BASELINE. AFTER THE COILS WERE POSITIONED AND THE ANEURYSM WAS COMPLETELY EXCLUDED FROM THE CIRCULATION, A SMALL AMOUNT OF THROMBUS WAS NOTED ON THE COIL BALL. REOPRO WAS ADMINISTERED. THE AMOUNT OF THROMBUS DIMINISHED OVER TIME AND WAS NEARLY GONE BY THE FINAL INJECTION. RAYMOND ROY GRADING SCALE: 1 (NO RESIDUAL FILLING OF THE ANEURYSM NECK OR DOME). THE SUBJECT WAS KEPT FOR 7 DAYS THEN WAS DISCHARGED HOME; THE MODIFIED RANKIN SCORE (MRS) AT DISCHARGE = 0. NO DIAGNOSTIC SCANS WERE TAKEN AT DISCHARGE. DIAGNOSTIC CT SCAN DONE THREE DAYS PRE COIL EMBOLIZATION SHOWED A RUPTURED RIGHT ICA WITH A HUNT HESS SCORE OF 1. THE RIGHT ICA ANEURYSM WAS 5.1 X 5.1 X 3.7 (NECK) MM. A PRE-OP CT SCAN DONE ONE DAY PRIOR TO TREATMENT SHOWED A SLIGHT INCREASE IN SAH. THE (B)(6) MALE WITH A MEDICAL HISTORY OF HYPERTENSION WAS ENROLLED IN THE STUDY AND TREATED WITH PLACEMENT OF FIVE COILS. THE SITE INDICATED THE EVENT AS RELATED TO THE PROCEDURE AND RELATED TO THE STUDY DEVICE. THE MEDICAL MONITOR INDICATED THE EVENT IS RELATED TO THE PROCEDURE AND POSSIBLY RELATED TO THE STUDY DEVICE. THE COILS REMAIN IMPLANTED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH ALL LOTS OF IMPLANTED COILS PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED EVENTS. BASED ON THE AVAILABLE INFORMATION, IT APPEARS THAT ANEURYSM/NECK CHARACTERISTICS LIKELY CONTRIBUTED TO THE GRADUAL 1MM PROTRUSION OF THE COIL MASS INTO THE PARENT VESSEL. INTRAVASCULAR THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ENDOVASCULAR PROCEDURES. PHARMACOLOGICAL AND CLINICAL FACTORS INCLUDING THE ANEURYSM CHARACTERISTICS, COIL PROTRUSION AND THIS PATIENT¿S PRE-PROCEDURE PRESENTATION WITH A RUPTURED ANEURYSM MAY HAVE CONTRIBUTED TO THE EVENT. THERE HAVE BEEN STUDIES SHOWING EVIDENCE FOR A GENERALIZED STRONG ACTIVATION OF THE COAGULATION AND FIBRINOLYTIC SYSTEM IN PATIENTS WITH SUBARACHNOID HEMORRHAGE. BASED ON THE REPORTED INFORMATION, THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING ISSUES RELATED TO THE REPORTED EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF FIVE PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 2954740-2012-00560, 2954740-2012-00561, 2954740-2012-00562, 2954740-2012-00563 AND 2954740-2012-00564.

    Description of Event or Problem · 1

    PER THE (B)(4) STUDY FOR PATIENT WITH ID (B)(6), INDICATED THAT AFTER THE COILS (MICRUSPHERE 10:11.9 CM (B)(4), MICRUSPHERE 10: 9.7 CM (B)(4), DELTAPAQ 10: 8 CM (B)(4), DELTAPAQ 10: 6 CM (B)(4), AND DELTAPAQ 10: 8 CM (B)(4)) WERE POSITIONED AND THE ANEURYSM WAS COMPLETELY EXCLUDED FROM THE CIRCULATION, A SMALL AMOUNT OF THROMBUS WAS NOTED ON THE COIL BALL. REPRO WAS ADMINISTERED. THE AMOUNT OF THROMBUS DIMINISHED OVER TIME AND WAS NEARLY GONE BY THE FINAL INJECTION. RAYMOND ROY GRADING SCALE: 1 (NO RESIDUAL FILLING OF THE ANEURYSM NECK OR DOME). SUBJECT WAS KEPT FOR 7 DAYS THEN WAS DISCHARGED HOME ON (B)(6) 2012, MR'S AT DISCHARGE = 0. NO DIAGNOSTIC SCANS WERE TAKEN AT DISCHARGE. IT WAS INDICATED THAT THE EVENT WAS RELATED TO THE PROCEDURE AND RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTAPAQ - PLATINUM MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA F47560

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening| R MICRUS COILS