BEUDAMED
    FDA Adverse Event Summary report: N

    ESSURE

    MDR report key: 3811192 · Received April 21, 2014

    Report

    Report Number
    2951250-2014-00118
    Date Received
    April 21, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP RECEIVED ON (B)(6) 2014 WITH NO NEW CLINICAL INFO. FOLLOW UP (B)(6) 2014: FOLLOW-UP INFO RECEIVED FROM THE CONSUMER. CONSUMER'S DATE OF BIRTH WAS ADDED TO CASE AND HER AGE, (B)(6) AND BMI 24.885. CONSUMER HAD 2 PREGNANCIES WITH 2 LIVE BIRTHS, LAST PREGNANCY WAS IN 2005. CONSUMER'S CONCOMITANT DISEASE INCLUDES HIGH BLOOD PRESSURE. CONSUMER HAD DYSFUNCTIONAL UTERINE BLEEDING AND HAD TO GET AN ABLATION. THAT WAS WHY SHE WANTED THE ESSURE BECAUSE THE DOCTOR TOLD HER NO MORE PREGNANCIES AFTER THE ABLATION WAS DONE. ESSURE WAS INSERTED IN (B)(6) 2010. CONSUMER REPORTED THAT SHE HAD TO HAVE HER TUBES TIED THE SAME DAY AS THE ESSURE PERFORATED HER TUBE AND A BLOOD VESSEL AND HAD TO BE REMOVED LAPAROSCOPICALLY. THE DOCTOR NOTICED DISCOLORATION OF HER ABDOMEN DURING THE INSERTION. HE PERFORMED LAPAROSCOPY AND REMOVED THE LEFT COIL, REPAIRED THE LEFT TUBE AND VESSEL. SHE THOUGHT SHE STILL HAD ONE IN THE RIGHT, THE HSG (HYSTEROSALPINGOGRAM) WAS NOT DONE. SHE HAD BOTH TUBES TIED. THE INCORRECT POSITION OF ESSURE WAS SEEN IMMEDIATELY DURING THE INSERTION. CONSUMER REPORTED THAT SHE HAD STILL ONE COIL IN THE RIGHT TUBE AND IT WAS STILL CAUSING PROBLEMS. SHE HAD PAIN AND HEADACHES WERE GETTING WORSE SINCE ESSURE INSERTION. CONSUMER REPORTED THAT PHYSICIAN WAS WATCHING THE SYMPTOMS. THE PAIN WAS REALLY BAD. SHE HAD AN ULTRASOUND WHICH SHOWED A SMALL CYST IN RIGHT OVARY. IF THE PAIN CONTINUES OR GETS ANY WORSE, SHE WILL HAVE TO HAVE A HYSTERECTOMY. SHE IS GOING TO THE DOCTORS MONTHLY. NEXT VISIT IN TWO WEEKS. CONSUMER CONSIDERED ALL THE EVENTS ARE RELATED TO ESSURE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE REPORT WAS RECEIVED ON (B)(6) 2014 FROM A CONSUMER IN THE UNITED STATES VIA THE FDA, THE REGULATORY AUTHORITY IN THE UNITED STATES (FDA CASE NUMBER MW5034701, RECEIVED AT FDA ON 02/21/2014). THE REPORT REFERS TO THE REPORTING FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) IMPLANTED AND ONE OF THE COILS RUPTURED FALLOPIAN TUBE AND ONE OF HER BLOOD ARTERIES OR VEINS, SHE EXPERIENCES SEVERE HEADACHES, PAIN AND PRESSURE IN HER BACK AND ABDOMEN, HEAVY MENSTRUAL CYCLE, BLOATING. ON FDA FORM REPORTED, REPORT TYPE WAS "INJURY", OUTCOME OF EVENTS WAS "OTHER SERIOUS (IMPORTANT MEDICAL EVENTS)." NO INFO WAS GIVEN ON PAST DRUGS, CONCOMITANT MEDICATION. CONSUMER'S HISTORY/CONCURRENT CONDITIONS INCLUDED ENDOMETRIAL ABLATION IN 2010 FOR HEAVY MENSTRUAL BLEEDING TO PREVENT ANEMIA. UNDER ADVISE OF HER DOCTOR, STERILIZATION WAS RECOMMENDED TO PREVENT PREGNANCY AFTER THE ABLATION PROCEDURE. ON (B)(6) 2010, THE CONSUMER HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) IMPLANTED FOR STERILIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241458 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention