BEUDAMED
    FDA Adverse Event Summary report: N

    ESSURE

    MDR report key: 3884542 · Received June 13, 2014

    Report

    Report Number
    2951250-2014-00228
    Date Received
    June 13, 2014
    Report Date
    June 12, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP RECEIVED ON (B)(4) 2014: PRODUCT TECHNICAL GLOBAL ((B)(4)) AND LOCAL (B)(4) NUMBERS WERE RECEIVED. CASE CONSIDERED TO BE CLOSED. FOLLOW-UP RECEIVED ON (B)(4) 2014: NO NEW CLINICAL INFORMATION. CASE CONSIDERED TO BE CLOSED. CORRECTION(B)(4) 2014 FOLLOWING COMPANY INTERNAL CODING REVIEW: THE EVENT "DEVICE INSERTION COMPLICATION" WAS ADDED. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED REPORT REFERS TO A (B)(6) FEMALE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED INNER COIL STAYED BEHIND IN LEFT TUBA AND OUTER COIL DID NOT (DEVICE INSERTION COMPLICATION) AND COIL DID NOT RELEASE WELL. BOTH EVENTS ARE CONSIDERED NON-SERIOUS. INNER COIL STAYED BEHIND IN LEFT TUBA AND OUTER COIL DID NOT IS UNLISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE, WHILE THE OTHER EVENT IS LISTED. THE EVENT INNER COIL STAYED BEHIND IN LEFT TUBA AND OUTER COIL DID NOT (ASSUMED AS DEVICE BREAKAGE) WAS REGARDED AS NEAR-INCIDENT DUE TO THE REPORTED BREAKAGE. DURING DIFFICULT INSERTION, SINGLE CASES HAVE BEEN REPORTED OF ESSURE BREAKAGE. IN THIS PARTICULAR CASE, IT WAS ONLY MENTIONED THAT INNER COIL STAYED BEHIND IN LEFT TUBA AND OUTER COIL DID NOT WITHOUT DETAILS ABOUT THIS EVENT. THUS, CAUSALITY BETWEEN THE EVENTS ABOVE AND ESSURE USE WAS CONSIDERED AS RELATED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A GYNECOLOGIST/OBSTETRICIAN IN (B)(6) ON (B)(4) 2014 WHICH REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED INNER COIL STAYED BEHIND IN LEFT TUBA AND OUTER COIL DID NOT AND COIL DID NOT RELEASE WELL. NO INFORMATION GIVEN ON PATIENT'S HISTORY, PAST DRUGS AND CONCURRENT CONDITIONS. IT WAS NOT REPORTED WHETHER THE PATIENT RECEIVED ANY CONCOMITANT MEDICATION. ON (B)(6) 2013, THE PATIENT HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED. ON (B)(6) 2013, THE INNER COIL STAYED BEHIND WITH THE INSERTION. THEY FOUND THIS OUT WHEN THE PATIENT CAME AGAIN FOR AN INSERTION ON (B)(6) AND THIS DID NOT SUCCEED. ON (B)(6), A HYSTEROSALPINGOGRAM WAS PERFORMED AND THEN IT BECAME CLEAR THAT THE INNER COIL STAYED BEHIND AND HAS GROWN TOGETHER. SO ON (B)(6), NOT EVERYTHING HAS COME OUT. THE OUTER COIL DID, BUT NOT THE INNER COIL. THE INSERTION IN THE RIGHT TUBE WENT WELL ON (B)(6), BUT NOT IN THE LEFT ONE. REPORTER CAUSALITY: THE RELATIONSHIP BETWEEN THE EVENTS AND ESSURE IS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351308 ESSURE KNH- DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE HHS BAYER HEALTHCARE LLC ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR