BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7398559 · Received April 5, 2018

    Report

    Report Number
    2951250-2018-01481
    Event Type
    Injury
    Date Received
    April 5, 2018
    Date of Event
    June 8, 2016
    Report Date
    September 14, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: ABDOMEN/ MIGRATION OF ESSURE"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANT AND SHE SUBSEQUENTLY DELIVERED A BABY BOY") AND HIGH RISK PREGNANCY ("PREGNANCY (WITH COMPLICATIONS)/ HIGH RISK PREGNANCY") IN A 37-YEAR-OLD FEMALE PATIENT (GRAVIDA 3, PARA 3) WHO HAD ESSURE (BATCH NO. 863581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE USE ISSUE "ESSURE MICRO-INSERT IMPLANTED EARLIER THAN 6 WEEKS AFTER DELIVERY" ON (B)(6) 2013 AND DEVICE INEFFECTIVE "LACK OF DEVICE EFFECT". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED HIGH RISK PREGNANCY, MULTI GRAVIDA AND PARITY 3 (LIVE BIRTHS: (B)(6) 2001, (B)(6) 2013 AND (B)(6) 2015). VETERAN HAD A FAILED ESSURE PLACEMENT AND DOES NOT DESIRE ANOTHER CHILD. VETERAN HAD A FAILED ESSURE PLACEMENT AND DOES NOT DESIRE ANOTHER CHILD. EXAMINATION ABDOMEN SOFT NONTENDER NO MASSES EXTERNAL GENITALIA NORMAL. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: IUD FROM 2009 TO 2012. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED ADVERSE DRUG REACTION WITH IUD. CONCURRENT CONDITIONS INCLUDED POSTPARTUM STATE, PAIN NOS, SORE THROAT, UTERINE FIBROID (SMALL ANTERIOR FIBROID), VAGINAL BLEEDING, AMENORRHEA, OLIGOHYDRAMNIOS, VAGINAL DELIVERY, VAGINAL DISCHARGE (VAGINA AND CERVIX WITH HEAVY YELLOWISH VAGINAL DISCHARGE) AND VULVAL IRRITATION. IN (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND HIGH RISK PREGNANCY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2015, THE PATIENT EXPERIENCED AMNIOTIC FLUID VOLUME DECREASED ("LOW AMNIOTIC FLUID LEVELS"). ON (B)(6) 2016, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. ESSURE TREATMENT WAS NOT CHANGED. ON (B)(6) 2015, THE PREGNANCY WITH CONTRACEPTIVE DEVICE AND HIGH RISK PREGNANCY HAD RESOLVED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION AND AMNIOTIC FLUID VOLUME DECREASED OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED AMNIOTIC FLUID VOLUME DECREASED, DEVICE DISLOCATION, HIGH RISK PREGNANCY AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT HAD TUBAL LIGATION ON (B)(6) 2015 AND ONSET OF ABDOMINAL PAIN WAS IN (B)(6) 2013. HIGH RISK PREGNANCY PRECAUTIONS WERE RECEIVED BY PATIENT AS TREATMENT FOR THE COMPLICATIONS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: CONFIRMED PLACEMENT OF DEVICES. PREGNANCY TEST URINE - ON (B)(6) 2015: PREGNANT . PATIENT UNDERGONE ESSURE CONFIRMATION TEST ON (B)(6) 2013. TYPE OF TEST: ABDOMINAL X-RAY. STATES HAD ESSURE TUBAL OCCLUSION IN (B)(6) 2013,CONCERNED FOR POSSIBLE ECTOPIC AS HAS HAD THREE POSITIVE PREGNANCY TESTS WITH 7 DAY LATE PERIOD. SEEKING RECOMMENDATION FROM PCP FOR DIAGNOSTIC AS CONCERNED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-SEP-2018: QUALITY-SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT ). INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: ABDOMEN/ MIGRATION OF ESSURE"), PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANT AND SHE SUBSEQUENTLY DELIVERED A BABY BOY") AND HIGH RISK PREGNANCY ("PREGNANCY (WITH COMPLICATIONS)/ HIGH RISK PREGNANCY") IN A (B)(6) FEMALE PATIENT (GRAVIDA 3, PARA 3) WHO HAD ESSURE (BATCH NO. 863581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE USE ISSUE "ESSURE MICRO-INSERT IMPLANTED EARLIER THAN 6 WEEKS AFTER DELIVERY" ON (B)(6) 2013 AND DEVICE INEFFECTIVE "LACK OF DEVICE EFFECT". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED HIGH RISK PREGNANCY, MULTI GRAVIDA AND PARITY 3 (LIVE BIRTHS: (B)(6) 2001, (B)(6) 2013 AND (B)(6) 2015). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: IUD. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED ADVERSE DRUG REACTION WITH IUD. CONCURRENT CONDITIONS INCLUDED POSTPARTUM STATE. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND HIGH RISK PREGNANCY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2015, THE PATIENT EXPERIENCED AMNIOTIC FLUID VOLUME DECREASED ("LOW AMNIOTIC FLUID LEVELS"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH ABDOMINAL PAIN. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. ESSURE TREATMENT WAS NOT CHANGED. ON (B)(6) 2015, THE PREGNANCY WITH CONTRACEPTIVE DEVICE AND HIGH RISK PREGNANCY HAD RESOLVED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION AND AMNIOTIC FLUID VOLUME DECREASED OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE REPORTER CONSIDERED AMNIOTIC FLUID VOLUME DECREASED, DEVICE DISLOCATION, HIGH RISK PREGNANCY AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT HAD TUBAL LIGATION ON (B)(6) 2015 AND ONSET OF ABDOMINAL PAIN WAS IN (B)(6) 2013. HIGH RISK PREGNANCY PRECAUTIONS WERE RECEIVED BY PATIENT AS TREATMENT FOR THE COMPLICATIONS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: CONFIRMED PLACEMENT OF DEVICES. PREGNANCY TEST URINE - ON (B)(6) 2015: PREGNANT. PATIENT UNDERGONE ESSURE CONFIRMATION TEST ON (B)(6) 2013. TYPE OF TEST: ABDOMINAL X-RAY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-FEB-2018: PLAINTIFF FACT SHEET RECEIVED. REPORTER INFORMATION, PATIENT¿S DEMOGRAPHIC INFORMATION, RELEVANT HISTORY AND LAB DATA UPDATED. ESSURE LOT NUMBER WAS ADDED. EVENTS DEVICE DISLOCATION WITH ABDOMINAL PAIN, HIGH RISK PREGNANCY, LOW AMNIOTIC FLUID LEVELS WERE NEWLY ADDED. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, (B)(4) TO BAYER PHARMA (B)(4), AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY. INCIDENT. AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242740 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 863581

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other| R