BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8389471 · Received March 5, 2019

    Report

    Report Number
    2951250-2019-01004
    Event Type
    Injury
    Date Received
    March 5, 2019
    Report Date
    April 8, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("MIGRATION/PERFORATION / MIGRATED IMPLANT HAD PERFORATED FALLOPIAN TUBE/ RIGHT ESSURE COIL PROTRUDING FROM THE CORNUA AND EMBEDDED INTO THE POSTERIOR UTERINE WALL"), EMBEDDED DEVICE ("RIGHT ESSURE COIL PROTRUDING FROM RIGHT FALLOPIAN TUBE APPROXIMATELY 2CM FROM THE CORNUA AND EMBEDDED INTO THE POSTERIOR UTERINE WALL") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("POST-IMPLANT PREGNANCY") IN AN ADULT 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". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3, ADNEXAL MASS, ADHESION, D & C, OVARIAN ADHESION AND FIBROIDS. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND PELVIC PAIN ("PAIN") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2010. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, EMBEDDED DEVICE, PREGNANCY WITH CONTRACEPTIVE DEVICE AND PELVIC PAIN OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: PROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 9, PARA 3. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED EMBEDDED DEVICE, FALLOPIAN TUBE PERFORATION, PELVIC PAIN AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-APR-2019: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("MIGRATION/PERFORATION/MIGRATED IMPLANT HAD PERFORATED FALLOPIAN TUBE/RIGHT ESSURE COIL PROTRUDING FROM THE CORNUA AND EMBEDDED INTO THE POSTERIOR UTERINE WALL") AND EMBEDDED DEVICE ("RIGHT ESSURE COIL PROTRUDING FROM RIGHT FALLOPIAN TUBE APPROXIMATELY 2CM FROM THE CORNUA AND EMBEDDED INTO THE POSTERIOR UTERINE WALL") IN AN ADULT 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". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 3, ADNEXAL MASS, ADHESION, D & C, PELVIC ADHESIONS AND FIBROIDS. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND PELVIC PAIN ("PAIN") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("POST-IMPLANT PREGNANCY"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2010. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, EMBEDDED DEVICE, PREGNANCY WITH CONTRACEPTIVE DEVICE AND PELVIC PAIN OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: PROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 9, PARA 3. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED EMBEDDED DEVICE, FALLOPIAN TUBE PERFORATION, PELVIC PAIN AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. 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
    182477 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R