BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CASHMERE 14 - PLATINUM MICROCOIL

    MDR report key: 2781691 · Received October 11, 2012

    Report

    Report Number
    2954740-2012-00740
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    July 26, 2011
    Report Date
    September 18, 2012
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K022420
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD NO MEDICAL HISTORY. THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 11.9MM, AND THE NECK TO SAC RATIO WAS 11.9MM: 25.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 4.1MM AND DISTALLY WAS 4.2MM. MRS BEFORE THE PROCEDURE ON (B)(6) 2011 WAS 0. THE ACT WAS 121 SECONDS PRE ANTICOAGULATION AND 324 SECONDS POST ANTICOAGULATION. NO INFORMATION REGARDING INR, PT, AND PTT. THE OCCLUSION RATE OF ANEURYSM WAS 96% AFTER THE PROCEDURE. AT THE TIME OF FOLLOW-UP (ON (B)(6) 2012), THE ANEURYSM NECK WAS 11.9MM, AND THE NECK TO SAC RATIO WAS 11.9MM:25.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 4.1MM AND DISTALLY WAS 4.2MM. THE OCCLUSION RATE OF ANEURYSM WAS 95%. AT THE TIME OF ONE YEAR FOLLOW UP ON (B)(6) 2012, MRS WAS 1. ANTIPLATELET THERAPY INCLUDED ASPIRIN 100MG/DAY, CLOPIDOGREL SULFATE 75MG/DAY, HEPARIN7,000U, AND ARGATROBAN HYDRATE 60MG. PRIOR TO IMPLANTING THE VRD, AN ENVOY GUIDE CATHETER (CAT/LOT# UNKNOWN), AXCELGUIDE-MEDIKIT, PROWLER SELECT PLUS MICROCATHETER (606-S255X/LOT # UNKNOWN), CHIKAI/ASAHI (B)(4) WERE UTILIZED. OTHER DEVICES UTILIZED DURING THE PROCEDURE WERE AN EXCELSIOR 1018/STRYKER, ECHELON-14/COVIDIEN (B)(4), CHIKAI/ASAHI (B)(4). NO FURTHER INFORMATION IS AVAILABLE AND PROCEDURAL IMAGES ARE NOT AVAILABLE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THIS IS ONE OF MULTIPLE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT, WHICH IS ASSOCIATED WITH MFG REPORT 2954740-2012-00734, 2954740-2012-00735, 1058196-2012-00382, 1058196-2012-00383, 1058196-2012-00384, 2954740-2012-00736, 2954740-2012-00737, 2954740-2012-00738, 2954740-2012-00739, 2954740-2012-00740, AND 2954740-2012-00741.

    Description of Event or Problem · 1

    THE REPORT INDICATED THAT THE PROCEDURE WAS COIL EMBOLIZATION ASSISTED WITH AN ENTERPRISES VRD (ENC453712/01426909) AND CODMAN AND NON-CODMAN COILS (GDC-STRYKER X15, V-TRACK MICROPLEX-TERUMO X14, SRC14092220/F42782, SRC14092220/J10167, ED EXTRA SOFT X27, 637CF0615/15179306, 637CF0615/1515605, 638CF0615/15258730, SRC14061520/J10180, SRC14051220/F40526, SRC14051220/F52209, SRC14051220/F50729, SRC14061520/J10272, SRC14061520/J10201) OF LEFT THE CAVERNOUS SINUS ANEURYSM, AND FOUR MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT DEVELOPED DIPLOPIA ASSOCIATED WITH LEFT ABDUCENS NERVE PARALYSIS. ACTION TAKEN WAS ADMINISTRATION OF MECOBALAMIN. THE EVENT OUTCOME AS OF ONSET WAS INDICATED AS ONGOING AND UNCHANGED. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS UNRELATED AND TO THE VRD WAS ALSO UNRELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASHMERE 14 - PLATINUM MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA J10272

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention