BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8886756 · Received August 13, 2019

    Report

    Report Number
    2951250-2019-04711
    Event Type
    Injury
    Date Received
    August 13, 2019
    Date of Event
    March 21, 2017
    Report Date
    August 13, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ('THE INTRAMURAL PORTION OF THE FALLOPIAN TUBES HAVE EMBEDDED SILVER COILED METALLIC WIRE') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED VAGINAL BLEEDING, ORAL CONTRACEPTIVE, PLANTAR FASCIA RELEASE SURGERY, MENORRHAGIA AND UTERINE ABLATION. CONCURRENT CONDITIONS INCLUDED BACK PAIN, BLOATING, CONSTIPATION, DIARRHEA, UTERINE BLEEDING, ABDOMINAL PAIN, DYSURIA, PERINEAL PAIN, MENOPAUSE, VAGINAL BURNING SENSATION AND CERVICITIS. CONCOMITANT PRODUCTS INCLUDED INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS) FROM 2013 TO 2014 FOR BIRTH CONTROL. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2015, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("PAIN/ LOWER ABDOMINAL PAIN/ CRAMPING") AND DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"). ON (B)(6) 2017, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 2 YEARS 3 MONTHS AFTER INSERTION OF ESSURE. THE PATIENT WAS TREATED WITH SURGERY (TOTAL HYSTERECTOMY/UTERUS AND CERVIX REMOVED, ENDOMETRIAL ABLATION). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN LOWER AND DYSMENORRHOEA HAD RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR EMBEDDED DEVICE WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER AND DYSMENORRHOEA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: FLUFFY TISSUE ON RIGHT, ABOULE TO PLACE EASILY--ONE COIL. 2-3 ON LEFT SIDE. PREVIOUSLY REPORTED INSERTION DATE: (B)(6) 2014. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2015: TOTAL BILATERAL OCCLUSION. PREGNANCY TEST URINE - ON (B)(6) 2016: NEGATIVE; ON (B)(6) 2017: NEGATIVE. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING EVENTS WERE CONFIRMED VIA PATIENTS MEDICAL RECORD: ABDOMINAL PAIN. CONCERNING THE INJURIES REPORTED IN THIS CASE THE FOLLOWING EVENT WAS VIA PATIENTS MEDICAL RECORD: EMBEDDED DEVICE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-AUG-2019: PFS AND MEDICAL RECORD RECEIVED - PREVIOUSLY REPORTED EVENT ¿INJURY¿ UPDATED TO ¿PAIN / LOWER ABDOMINAL PAIN / CRAMPING¿. EVENTS DYSMENORRHEA (CRAMPING), THE INTRAMURAL PORTION OF THE FALLOPIAN TUBES HAVE EMBEDDED SILVER COILED METALLIC WIRE ADDED. REPORTER, LAB DATA, MEDICAL HISTORY, PATIENT DEMOGRAPHICS ADDED. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681105 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other| R