BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10199880 · Received June 26, 2020

    Report

    Report Number
    2951250-2020-09654
    Event Type
    Injury
    Date Received
    June 26, 2020
    Report Date
    June 4, 2021
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. IN (B)(6) 2012, 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 REMOVAL (B)(6) 2019). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE OF INSERTION (B)(6) 2012 AND (B)(6) 2014 DATE(S) OF INSERTION: (B)(6) 2018 (DISCREPANCY NOTED), AS PER PIF, (B)(6) 2014(DISCREPANCY NOTED PER PIF), (B)(6) 2014 AS PER PIF. DISCREPANCY NOTED: ESSURE REMOVAL DATE AS PER PIF IS (B)(6) 2019. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PATHOLOGY TEST - ON AN UNKNOWN DATE: A. FALLOPIAN TUBES, BILATERAL, SALPINGECTOMY: BILATERAL FALLOPIAN TUBES, COMPLETELY TRANSECTED, ONE WITH PARATUBAL CYST. E. UTERUS AND CERVIX, HYSTERECTOMY: MILD CHRONIC CERVICITIS. EARLY SECRETORY PATTERN ENDOMETRIUM. SUPERFICIAL ADENOMYOSIS. BILATERAL FALLOPIAN TUBES WITH NO SIGNIFICANT PATHOLOGIC CHANGE. INTACT AND IN PLACE BIRTH CONTROL DEVICES. C. SOFT TISSUE, INTRA-ABDOMINAL, REMOVAL: FIBROTIC AND PARTIALLY CALCIFIED TISSUE CONSISTENT WITH INFARCTED EPIPLOIC APPENDAGE. CLINICAL INFORMATION: ABNORMAL UTERINE BLEEDING, HEAVY MENSTRUAL BLEEDING. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-APR-2021: PIF RECEIVED: REPORTER AND RCC ADDED. 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.

    Additional Manufacturer Narrative · 0

    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. IN (B)(6) 2012, 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 REMOVAL (B)(6) 2019). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE OF INSERTION (B)(6) 2012 AND (B)(6) 2014 DATE(S) OF INSERTION: (B)(6) 2018 (DISCREPANCY NOTED), AS PER PIF, (B)(6) 2014(DISCREPANCY NOTED PER PIF), ,(B)(6) 2014 AS PER PIF. DISCREPANCY NOTED: ESSURE REMOVAL DATE AS PER PIF IS (B)(6) 2019. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PATHOLOGY TEST - ON AN UNKNOWN DATE: A. FALLOPIAN TUBES, BILATERAL, SALPINGECTOMY: BILATERAL FALLOPIAN TUBES, COMPLETELY TRANSECTED, ONE WITH PARATUBAL CYST. E. UTERUS AND CERVIX, HYSTERECTOMY: MILD CHRONIC CERVICITIS. EARLY SECRETORY PATTERN ENDOMETRIUM. SUPERFICIAL ADENOMYOSIS. BILATERAL FALLOPIAN TUBES WITH NO SIGNIFICANT PATHOLOGIC CHANGE. INTACT AND IN PLACE BIRTH CONTROL DEVICES. C. SOFT TISSUE, INTRA-ABDOMINAL, REMOVAL: FIBROTIC AND PARTIALLY CALCIFIED TISSUE CONSISTENT WITH INFARCTED EPIPLOIC APPENDAGE. CLINICAL INFORMATION: ABNORMAL UTERINE BLEEDING, HEAVY MENSTRUAL BLEEDING. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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 AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-JUN-2021: 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 MEDICAL DEVICE REMOVAL ('ESSURE REMOVAL') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. IN (B)(6) 2012, 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 REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE OF INSERTION (B)(6) 2012 AND 2014. DATE(S) OF INSERTION: (B)(6) 2018 (DISCREPANCY NOTED), AS PRE PIF. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-JAN-2020: PIF RECEIVED: CASE BECOME SERIOUS INCIDENT, ESSURE REMOVAL DATE ADDED AS (B)(6) 2019. 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
    662875 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R