BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7531534 · Received May 22, 2018

    Report

    Report Number
    2951250-2018-02309
    Event Type
    Injury
    Date Received
    May 22, 2018
    Date of Event
    January 1, 2012
    Report Date
    August 9, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("MIGRATION/PERFORATION OF THE ESSURE DEVICE"), FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE)") AND DEVICE DISLOCATION ("MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: ESSURE COILS NOT FOUND") IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952114) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "DEVICE REMOVAL FAILED". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIPAROUS. CONCURRENT CONDITIONS INCLUDED STRESS, HUMAN PAPILLOMA VIRUS INFECTION AND RESTLESS LEG SYNDROME. CONCOMITANT PRODUCTS INCLUDED CILEST (ORTHO TRI-CYCLEN), CYCLOBENZAPRINE, METRONIDAZOLE (METROGEL), SUMATRIPTAN (IMITREX), TRANEXAMIC ACID (LYSTEDA) AND VENLAFAXINE (EFFEXOR). ON AN UNKNOWN DATE, THE PATIENT STARTED MIRAPEX AT AN UNSPECIFIED DOSE AND FREQUENCY. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 2 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND NAUSEA ("NAUSEA"). ON (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN 2012, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2014, THE PATIENT EXPERIENCED BACTERIAL INFECTION ("BACTERIAL INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION") AND VULVOVAGINAL MYCOTIC INFECTION ("YEAST INFECTION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED BACK PAIN ("LOWER BACK PAIN") AND ABDOMINAL PAIN UPPER ("STOMACH PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY IN 2017.ESSURE COILS COULD NOT BE FOUND.), SURGERY (HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY IN 2017.ESSURE COILS COULD NOT BE FOUND.) AND SURGERY (HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY IN 2017.ESSURE COILS COULD NOT BE FOUND.). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, FALLOPIAN TUBE PERFORATION, DEVICE DISLOCATION, VAGINAL HAEMORRHAGE, MENORRHAGIA, BACTERIAL INFECTION, VAGINAL INFECTION, VULVOVAGINAL MYCOTIC INFECTION, NAUSEA, DYSMENORRHOEA, DYSPAREUNIA, BACK PAIN AND ABDOMINAL PAIN UPPER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN UPPER, BACK PAIN, BACTERIAL INFECTION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, NAUSEA, UTERINE PERFORATION, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND VULVOVAGINAL MYCOTIC INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAN: PATIENT WILL BE SCHEDULED FOR DAVINCI HYSTERCTOMY AND REMOVAL OF TUBES WITH THE ESSURE. ATTEMPTED ESSURE REMOVAL BY HYSTERECTOMY,BUT COILS COULD NOT BE FOUND. HYSTEROSALPINGOGRAM:OTHER (PLEASE DESCRIBE):ESSURE LINEAR COIL DENSITIES PROJECTING OVER THE UPPER SACRUM, WELL AWAY FROM THE EXPECTED LOCATION QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: QUALITY SAFETY EVALUATION OF PTC INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("MIGRATION/PERFORATION OF THE ESSURE DEVICE"), FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE)") AND DEVICE DISLOCATION ("MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: ESSURE COILS NOT FOUND") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952114) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "DEVICE REMOVAL FAILED". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIPAROUS. CONCURRENT CONDITIONS INCLUDED STRESS, HUMAN PAPILLOMA VIRUS INFECTION AND RESTLESS LEG SYNDROME. CONCOMITANT PRODUCTS INCLUDED CILEST (ORTHO TRI-CYCLEN), CYCLOBENZAPRINE, METRONIDAZOLE (METROGEL), SUMATRIPTAN (IMITREX), TRANEXAMIC ACID (LYSTEDA) AND VENLAFAXINE (EFFEXOR). ON AN UNKNOWN DATE, THE PATIENT STARTED MIRAPEX AT AN UNSPECIFIED DOSE AND FREQUENCY. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 2 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND NAUSEA ("NAUSEA"). ON (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN 2012, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN 2014, THE PATIENT EXPERIENCED BACTERIAL INFECTION ("BACTERIAL INFECTION"), VAGINAL INFECTION ("VAGINAL INFECTION") AND FUNGAL INFECTION ("YEAST INFECTION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), BACK PAIN ("LOWER BACK PAIN") AND ABDOMINAL PAIN UPPER ("STOMACH PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY IN 2017. ESSURE COILS COULD NOT BE FOUND.), SURGERY (HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY IN 2017. ESSURE COILS COULD NOT BE FOUND.) AND SURGERY (HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY IN 2017. ESSURE COILS COULD NOT BE FOUND.). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE UTERINE PERFORATION, FALLOPIAN TUBE PERFORATION, DEVICE DISLOCATION, VAGINAL HAEMORRHAGE, MENORRHAGIA, BACTERIAL INFECTION, VAGINAL INFECTION, FUNGAL INFECTION, NAUSEA, DYSMENORRHOEA, DYSPAREUNIA, BACK PAIN AND ABDOMINAL PAIN UPPER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN UPPER, BACK PAIN, BACTERIAL INFECTION, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FUNGAL INFECTION, MENORRHAGIA, NAUSEA, UTERINE PERFORATION, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAN: PATIENT WILL BE SCHEDULED FOR DAVINCI HYSTERECTOMY AND REMOVAL OF TUBES WITH THE ESSURE. ATTEMPTED ESSURE REMOVAL BY HYSTERECTOMY,BUT COILS COULD NOT BE FOUND. HYSTEROSALPINGOGRAM:OTHER (PLEASE DESCRIBE): ESSURE LINEAR COIL DENSITIES PROJECTING OVER THE UPPER SACRUM, WELL AWAY FROM THE EXPECTED LOCATION MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PFS AND M.R RECEIVED: LOT NUMBER, REPORTER INFORMATION, OTHER RELEVANT HISTORY, LAB DATA, EVENTS- PERFORATION (FALLOPIAN TUBE), MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: ESSURE COILS NOT FOUND, ABNORMAL BLEEDING (VAGINAL), MENORRHAGIA, BACTERIAL INFECTION, VAGINAL INFECTION, YEAST INFECTION, NAUSEA, DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), LOWER BACK PAIN, STOMACH PAIN, DEVICE REMOVAL FAILED WERE ADDED. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376695 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 952114

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other| R CYCLOBENZAPRINE| CYCLOBENZAPRINE| EFFEXOR| EFFEXOR| IMITREX| IMITREX| LYSTEDA| LYSTEDA| METROGEL| METROGEL| ORTHO TRI-CYCLEN| ORTHO TRI-CYCLEN| CYCLOBENZAPRINE| EFFEXOR| IMITREX| LYSTEDA| METROGEL| ORTHO TRI-CYCLEN