BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7062576 · Received November 28, 2017

    Report

    Report Number
    2951250-2017-09091
    Event Type
    Injury
    Date Received
    November 28, 2017
    Date of Event
    November 11, 2010
    Report Date
    May 18, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF STILLBIRTH ("BIRTH OF A STILLBORN BABY") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("BIRTH OF A STILLBORN BABY") IN A 35-YEAR-OLD FEMALE PATIENT (GRAVIDA 4, PARA 3) WHO HAD ESSURE (BATCH NO. 678810) INSERTED FOR FEMALE STERILISATION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3 (B)(6) 1999, (B)(6) 2000, (B)(6) 2009 AND STILLBIRTH NOS ON (B)(6) 2009. CONCURRENT CONDITIONS INCLUDED SWOLLEN ANKLES, RASH AND IRREGULAR MENSTRUATION. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, 9 MONTHS 23 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED STILLBIRTH (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). 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. AT THE TIME OF THE REPORT, THE STILLBIRTH AND PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS STILLBIRTH. THE REPORTER CONSIDERED PREGNANCY WITH CONTRACEPTIVE DEVICE AND STILLBIRTH TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HEART RATE - ON (B)(6) 2013: 144 BEATS/MIN (ELEVATED). HYSTEROSALPINGOGRAM - ON (B)(6) 2010: FULL OCCLUSION OF FALLOPIAN TUBES. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-MAR-2018: PLAINTIFF FACT SHEET AND MEDICAL RECORD RECEIVED. NEW REPORTERS ADDED. ESSURE INDICATION UPDATED AND LOT NUMBER ADDED. IT WAS REPORTED THAT ESSURE DEVICE WAS NOT REMOVED. 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 (B)(6) ("BIRTH OF A (B)(6) BABY") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("BIRTH OF A (B)(6) BABY") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR BIRTH CONTROL. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED (B)(6) (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). 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. IN 2011, THE PREGNANCY WITH CONTRACEPTIVE DEVICE HAD RESOLVED. AT THE TIME OF THE REPORT, THE (B)(4) OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS (B)(6). THE REPORTER CONSIDERED PREGNANCY WITH CONTRACEPTIVE DEVICE AND (B)(6) TO BE RELATED TO ESSURE. INCIDENT: NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. 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
    844565 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 678810

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other| R