BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10514743 · Received September 10, 2020

    Report

    Report Number
    2951250-2020-14110
    Event Type
    Injury
    Date Received
    September 10, 2020
    Report Date
    September 23, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION/ONE DEVICE WAS NOT FOUND') AND ABDOMINAL PAIN ('ABDOMINAL PAIN') IN A 39-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("HEAVY MENSTRUAL PERIODS"), IRON DEFICIENCY ANAEMIA ("IRON DEFICIENCY ANEMIA"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), AUTOIMMUNE DISORDER ("AUTO-IMMUNE SYMPTOMS") AND HYPERSENSITIVITY ("HYPERSENSITIVITY") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("POST-ESSURE PREGNANCY"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY AND SHE REQUIRED SECOND SURGERY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, ABDOMINAL PAIN, MENORRHAGIA, GENITAL HAEMORRHAGE, AUTOIMMUNE DISORDER, HYPERSENSITIVITY AND PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN AND THE IRON DEFICIENCY ANAEMIA HAD NOT RESOLVED. PREGNANCY RELATED INFORMATION: PROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED ABDOMINAL PAIN, AUTOIMMUNE DISORDER, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, IRON DEFICIENCY ANAEMIA, MENORRHAGIA AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2009: RESULTS: FALLOPIAN TUBES OCCLUDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-SEP-2020: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION/ONE DEVICE WAS NOT FOUND') AND ABDOMINAL PAIN ('ABDOMINAL PAIN') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("HEAVY MENSTRUAL PERIODS"), IRON DEFICIENCY ANAEMIA ("IRON DEFICIENCY ANEMIA"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), AUTOIMMUNE DISORDER ("AUTO-IMMUNE SYMPTOMS") AND HYPERSENSITIVITY ("HYPERSENSITIVITY") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("POST-ESSURE PREGNANCY"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY AND SHE REQUIRED SECOND SURGERY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, ABDOMINAL PAIN, MENORRHAGIA, GENITAL HAEMORRHAGE, AUTOIMMUNE DISORDER, HYPERSENSITIVITY AND PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN AND THE IRON DEFICIENCY ANAEMIA HAD NOT RESOLVED. PREGNANCY RELATED INFORMATION: PROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED ABDOMINAL PAIN, AUTOIMMUNE DISORDER, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, IRON DEFICIENCY ANAEMIA, MENORRHAGIA AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2009: RESULTS: FALLOPIAN TUBES OCCLUDED. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. 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. THE REPORTED MEDICAL EVENTS ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT AS NO BATCH NUMBER WAS REPORTED A TECHNICAL BATCH INVESTIGATION AND A REVIEW OF SIMILAR AE CASE REPORTS IS NOT POSSIBLE. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER INVESTIGATION THEREFORE THE COMPLAINT COULD NOT BE EVALUATED IN GREATER DETAIL. THE TECHNICAL ASSESSMENT CONCLUDED A QUALITY DEFECT WAS NOT CONFIRMED BUT CONSIDERED PLAUSIBLE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: PIF RECEIVED: EVENTS ADDED: MIGRATION, ABNORMAL BLEEDING, AUTO-IMMUNE OR HYPERSENSITIVITY SYMPTOMS, PREGNANCY, DEVICE INEFFECTIVE. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977363 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other| R