BEUDAMED
    FDA Adverse Event Summary report: N

    ESSURE

    MDR report key: 3872081 · Received June 4, 2014

    Report

    Report Number
    2951250-2014-00192
    Date Received
    June 4, 2014
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.

    Additional Manufacturer Narrative · 1

    FOLLOW UP INFORMATION RECEIVED ON (B)(6)-2014: PTC INVESTIGATION. FINAL ASSESSMENT: SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT, OUTER CATHETER, THE INNER CATHETER, AND ALL PARTS WITHIN THE HANDLE ASSEMBLY TO CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR AND INSPECT THE DEVICE TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. IN THIS CASE, WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT AT THIS TIME. MEDICAL ASSESSMENT: THE DISLOCATION EVENT REPORTED IS A POSSIBLE UNDESIRABLE EVENT WITH THE USE OF ESSURE AND NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. FOUR (4) ADDITIONAL AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO BATCH NUMBER B59462 BUT NONE OF THESE CASES REFERS TO ANY SIMILAR TYPE OF DISLOCATION EVENT. NO BATCH SIGNAL COULD BE IDENTIFIED AT THIS TIME. THE REVIEW OF THE LOT HISTORY RECORDS CONFIRMED THAT THE PRODUCT MET PRODUCT RELEASE SPECIFICATIONS. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. AT THE TIME OF THIS MEDICAL ASSESSMENT THE TECHNICAL INVESTIGATION CONCLUDED "UNCONFIRMED QUALITY DEFECT". BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT. EVALUATION SUMMARY: FINAL ASSESSMENT: SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT, OUTER CATHETER, THE INNER CATHETER, AND ALL PARTS WITHIN THE HANDLE ASSEMBLY TO CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR AND INSPECT THE DEVICE TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. IN THIS CASE, WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT AT THIS TIME.

    Description of Event or Problem · 1

    MICRO INSERT WAS IN THE ABDOMEN (ESSURE MIGRATION), ONE TUBE PATENT [DEVICE DISLOCATION INTO ABDOMINAL CAVITY] CASE DESCRIPTION: CASE DESCRIPTION: SERIOUS, RELATED, LISTED (INCIDENT) THIS SPONTANEOUS CASE REPORT WAS RECEIVED FROM A GYNECOLOGIST/OBSTETRICIAN IN THE UNITED STATES ON (B)(6)-2014. THE REPORT REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND ONE MICRO INSERT WAS FOUND IN THE ABDOMEN (ESSURE MIGRATION), ONE TUBE WAS PATENT. NO INFORMATION WAS GIVEN ON PATIENT'S HISTORY, PAST DRUGS, CONCOMITANT MEDICATION AND CONCURRENT CONDITIONS. ON (B)(6)-2014, THE PATIENT STARTED ESSURE (FALLOPIAN TUBE OCCLUSION INSERT), LOT NUMBER B59462, IMPLANTED FOR CONTRACEPTION. GYNECOLOGIST/OBSTETRICIAN STATED THAT ON (B)(6)-2014, HE COMPLETED ALTO (LAPAROSCOPIC TUBAL LIGATION) ON ONE SIDE OF PATIENT'S TUBAL ANATOMY WHICH PROVED TO BE PATENT AFTER ESSURE CONFIRMATION TEST. A FLAT SCAN X-RAY INDICATED THAT THE MICRO INSERT WAS IN THE ABDOMEN. DOCTOR REMOVED THE MICRO INSERT FROM THE OMENTUM. THE OUTCOME OF THE EVENT WAS NOT REPORTED. REPORTER DID NOT ASSESS DEVICE-EVENT RELATIONSHIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325729 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 B59462

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other