BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10553818 · Received September 18, 2020

    Report

    Report Number
    2951250-2020-14474
    Event Type
    Injury
    Date Received
    September 18, 2020
    Date of Event
    November 28, 2017
    Report Date
    April 6, 2021
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER, AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN'). IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802744), INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED: PELVIC PAIN AND PERINEAL PAIN. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2017, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 6 YEARS 6 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERINEAL PAIN ("PERINEAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY, CERVIX WITH BILATERAL FALLOPIAN TUBES AND OVARIES). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND PERINEAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN AND PERINEAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED: THE INSERTION DETAILS AS PER MR IS (B)(6) 2011. NO. OF COILS: NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE RIGHT UTERINE CAVITY WAS 2. THE IDENTICAL STEPS WERE UNDERTAKEN TO INSERT THE ESSURE MICROINSERTION IN THE OPPOSITE TUBE. THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 3. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM: ON (B)(6) 2011, FINDINGS SHOWED APPROPRIATELY BLOCKED FALLOPIAN TUBES WITH NO SPILLAGE OF DYE. ESSURE DEVICES WERE SEEN IN THE APPROPRIATE LOCATION. PREGNANCY TEST URINE: ON (B)(6) 2011, NEGATIVE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021, MR RECEIVED: REPORTER INFORMATION, LOT NO, OTHER RELEVANT HISTORY, LAB DATA ADDED. AND RCC WAS UPDATED. EVENT: MEDICAL DEVICE REMOVAL WAS REPLACED WITH EVENT PELVIC PAIN FEMALE. EVENT: PERINEAL PAIN ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED. INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA. SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('ESSURE REMOVAL') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2017, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 6 YEARS 6 MONTHS AFTER INSERTION OF ESSURE. THE PATIENT WAS TREATED WITH SURGERY (ESSSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN A 32-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802744) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PELVIC PAIN AND PERINEAL PAIN. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2017, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 6 YEARS 6 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERINEAL PAIN ("PERINEAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY, CERVIX WITH BILATERAL FALLOPIAN TUBES AND OVARIES). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND PERINEAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN AND PERINEAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED: THE INSERTION DETAILS AS PER MR IS (B)(6) 2011. NO. OF COILS: NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE RIGHT UTERINE CAVITY WAS 2.THE IDENTICAL STEPS WERE UNDERTAKEN TO INSERT THE ESSURE MICROINSERT IN THE OPPOSITE TUBE. THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 3. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: FINDINGS SHOWED APPROPRIATELY BLOCKED FALLOPIAN TUBES WITH NO SPILLAGE OF DYE. ESSURE DEVICES WERE SEEN IN THE APPROPRIATE LOCATION. PREGNANCY TEST URINE - ON (B)(6) 2011: NEGATIVE. LOT NUMBER: 802744, MANUFACTURING DATE: 2010/11, EXPIRATION DATE: 2013/11. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-APR-2021: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS 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 MEDICAL DEVICE REMOVAL ('ESSURE REMOVAL') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. 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
    1018940 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 802744 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other| R