BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10251254 · Received July 9, 2020

    Report

    Report Number
    2951250-2020-11080
    Event Type
    Injury
    Date Received
    July 9, 2020
    Report Date
    September 29, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. (828566, 82856) - NOT VALID, 822374) INSERTED FOR FEMALE STERILISATION. THE PATIENT'S MEDICAL HISTORY INCLUDED UTERINE FIBROIDS, MENORRHAGIA AND ASTHMA. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY/LAPAROSCOPIC BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION DETAIL: BILATERAL LATERAL TUBAL OSTIA WERE IDENTIFIED. ON RIGHT TUBE ESSURE INTO EASILY INTO THE TUBAL OSTIA AFTER DEPLOYMENT 1 COIL WAS NOTE AND LEFT TUBAL OSTIA 4 ESSURE COILS VISIBLE. THE PATIENT TOLERATED PROCEDURE WELL. SURGICAL PATHOLOGY REPORT : NABOTHIAN CYSTS, SECRETORY ENDOMETRIUM, LEIOMYOMA LARGEST 6.6 CM WITH HYALINIZATION AND ADENOMYOSIS. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS CONFIRMED IN PATIENT¿S MEDICAL RECORD: "PELVIC PAIN ". LOT NUMBER REPORTED (82856 AND 828566) IS NOT VALID LOT NUMBER: 822374 MANUFACTURING DATE: 2011-01 EXPIRATION DATE: 2014-01 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: QUALITY SAFETY EVALUATION OF PTC 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 PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822374,828566) INSERTED FOR FEMALE STERILISATION. THE PATIENT'S MEDICAL HISTORY INCLUDED UTERINE FIBROIDS, MENORRHAGIA AND ASTHMA. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY/LAPAROSCOPIC BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION DETAIL: BILATERAL LATERAL TUBAL OSTIA WERE IDENTIFIED. ON RIGHT TUBE ESSURE INTO EASILY INTO THE TUBAL OSTIA AFTER DEPLOYMENT 1 COIL WAS NOTE AND LEFT TUBAL OSTIA 4 ESSURE COILS VISIBLE. THE PATIENT TOLERATED PROCEDURE WELL. SURGICAL PATHOLOGY REPORT : NABOTHIAN CYSTS, SECRETORY ENDOMETRIUM, LEIOMYOMA LARGEST 6.6 CM WITH HYALINIZATION AND ADENOMYOSIS. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS CONFIRMED IN PATIENT¿S MEDICAL RECORD: "PELVIC PAIN ". MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 8-SEP-2020: MEDICAL RECORD RECEIVED. PREVIOUSLY REPORTED UNSPECIFIED EVENT ¿MEDICAL DEVICE REMOVAL¿ WAS UPDATED TO MORE SPECIFIED EVENT "PELVIC PAIN¿. ESSURE LOT NUMBER ADDED. CASE UPDATED TO MEDICALLY CONFIRMED. PATIENT DATE OF BIRTH WAS ADDED. REPORTER ADDED. MEDICAL HISTORY ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE 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 ('MEDICAL DEVICE REMOVAL') IN A 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 (ESSURE REMOVED ON (B)(6) 2019). ESSURE WAS REMOVED. 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 24-FEB-2020: CASE CATEGORY WAS CHANGE FROM INVALID TO VALID DUE TO EVENT INJURY NOS WAS UPDATED TO MEDICAL DEVICE REMOVAL. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714210 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 828566, 82856 INVALID, 822374 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R