BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5904746 · Received August 25, 2016

    Report

    Report Number
    2951250-2016-01624
    Event Type
    Injury
    Date Received
    August 25, 2016
    Report Date
    October 18, 2016
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP RECEIVED ON 19-SEP-2016: QUALITY-SAFETY EVALUATION: THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT. THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS (B)(4). NO SAMPLE AVAILABLE FOR THIS INVESTIGATION. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. THE LIST OF SIMILAR CASES CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS WITH SIMILAR EVENTS CODED IN MEDDRA. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 22-SEP-2016 FOR THE FOLLOWING MEDDRA PREFERRED TERM: DEVICE DISLOCATION. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 739 CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THIS MEDDRA PT. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REPORT REFERS TO A (B)(6) FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND, ON UNSPECIFIED DATE, 1 ESSURE COIL COULD NOT BE FOUND ANYMORE (DEVICE MIGRATION). THIS EVENT IS LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. DURING ESSURE MICRO-INSERT THERAPY THERE IS A RISK THAT THE DEVICE COULD MOVE OUT OF FALLOPIAN TUBES, THIS MOVEMENT COULD BE AN EXPULSION (INTO UTERUS OR OUT OF THE BODY) OR MIGRATION (DISTAL FALLOPIAN TUBE OR PERITONEAL CAVITY). ALTHOUGH, IN THIS PARTICULAR CASE, THE EXACT ONSET DATE AND MECHANISM OF THE EVENT ARE UNKNOWN, GIVEN ITS NATURE; CAUSALITY WITH THE SUSPECT DEVICE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE ESSURE REMOVAL WILL BE REQUIRED (DEVICES REMOVAL PLANNED). OTHER NONSERIOUS EVENTS WERE REPORTED. ACCORDING TO PRODUCT TECHNICAL ANALYSIS, SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. NO FURTHER INFORMATION IS EXPECTED FROM CONSUMER.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE REPORT WAS RECEIVED BY REGULATORY AUTHORITY IN (B)(6) ON 09-MAR-2016 FROM A (B)(6) FEMALE CONSUMER AND FORWARDED TO BAYER ON 04-AUG-2016. ON (B)(6) 2010, ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) WAS INSERTED. ON (B)(6) 2010, THE CONSUMER EXPERIENCED PAINFUL PLACEMENT, LOW BLOOD PRESSURE AND SWEATING DURING ESSURE PLACEMENT. IN (B)(6) 2011, 12 MONTHS AFTER INSERTION, THE CONSUMER EXPERIENCED DEPRESSIVE FEELINGS, LOSS OF LIBIDO, TIREDNESS, MEMORY LOSS AND CONCENTRATION PROBLEMS. IN (B)(6) 2014, 42 MONTHS AFTER INSERTION, THE CONSUMER EXPERIENCED URINARY INCONTINENCE. ON UNSPECIFIED DATE, THE CONSUMER EXPERIENCED PAIN IN ABDOMEN, INCREASE OR HEAVY BLOOD LOSS DURING MENSTRUATION, BLOOD LOSS DURING COITUS, THIN STOOLS, PAIN DURING COITUS, PAIN IN HEAD, LOWER BACK PAIN, ANEMIA, VITAMIN DEFICIENCY, TINGLING AND HARD ABDOMEN. THOSE EVENTS LED HER TO WORK-RELATED PROBLEMS AND PROBLEMS WITH DAILY TASKS. ON UNSPECIFIED DATE, BLOOD TEST AND CONTROL POSITION OF ESSURE WERE PERFORMED, BUT THE DETAILS WERE NOT PROVIDED. ON UNSPECIFIED DATE, ULTRASOUND SCAN WAS PERFORMED, NOT FOR ESSURE, AND SHOWED SEVERAL EXAMINATIONS IN CONNECTION WITH COMPLAINTS. ON UNSPECIFIED DATE, 1 ESSURE COIL COULD NOT BE FOUND ANYMORE (DEVICE MIGRATION).SHE CONTACTED HER PHYSICIAN VARIOUS DOCTORS DUE TO COMPLAINTS. THE PHYSICIAN WAS CONSIDERING THE REMOVAL OF ESSURE. COMPANY CAUSALITY COMMENT:THIS SPONTANEOUS CASE REPORT REFERS TO A (B)(6) FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND, ON UNSPECIFIED DATE, 1 ESSURE COIL COULD NOT BE FOUND ANYMORE (DEVICE MIGRATION). THIS EVENT IS LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. DURING ESSURE MICRO-INSERT THERAPY THERE IS A RISK THAT THE DEVICE COULD MOVE OUT OF FALLOPIAN TUBES, THIS MOVEMENT COULD BE AN EXPULSION (INTO UTERUS OR OUT OF THE BODY) OR MIGRATION (DISTAL FALLOPIAN TUBE OR PERITONEAL CAVITY). ALTHOUGH, IN THIS PARTICULAR CASE, THE EXACT ONSET DATE AND MECHANISM OF THE EVENT ARE UNKNOWN, GIVEN ITS NATURE; CAUSALITY WITH THE SUSPECT DEVICE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE ESSURE REMOVAL WILL BE REQUIRED (DEVICES REMOVAL PLANNED).OTHER NONSERIOUS EVENTS WERE REPORTED. TECHNICAL ANALYSIS HAS BEEN REQUESTED.NO FURTHER INFORMATION IS EXPECTED FROM CONSUMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557098 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER HEALTHCARE LLC ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention| S