BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7070044 · Received November 30, 2017

    Report

    Report Number
    2951250-2017-09427
    Event Type
    Injury
    Date Received
    November 30, 2017
    Date of Event
    January 1, 2013
    Report Date
    April 17, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 ("PERFORATION (FALLOPIAN TUBE)"), DEVICE EXPULSION ("MIGRATION OF IMPLANT, EXPULSION OF ESSURE DEVICE,ESSURE FELL OUT DURING EXPULSION") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A25165) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CO-SUSPECT PRODUCTS INCLUDED PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED SPORTS INJURY AND MENSES DELAYED. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;ETONOGESTREL (NUVARING) AND NORETHISTERONE (MICRONOR). ON AN UNKNOWN DATE, THE PATIENT STARTED PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS] AT AN UNSPECIFIED DOSE AND FREQUENCY. ON (B)(6)2013, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), TOOTH DISORDER ("DENTAL PROBLEMS") AND ALOPECIA ("HAIR LOSS"). IN 2014, THE PATIENT EXPERIENCED URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES: URINARY INCONTINENCE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA") AND ABDOMINAL PAIN ("ABDOMINAL PAIN") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY ((B)(6)2014, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2014. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE EXPULSION, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY INCONTINENCE, MIGRAINE, HEADACHE, NAUSEA, TOOTH DISORDER, ALOPECIA AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, DEVICE EXPULSION, FALLOPIAN TUBE PERFORATION, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PREGNANCY WITH CONTRACEPTIVE DEVICE, TOOTH DISORDER, URINARY INCONTINENCE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TRAILING COIL LEFT 2, RIGHT 3 INSERTION DATE PREVIOUSLY REPORTED AS (B)(6)2013 AND REMOVAL DATE (B)(6)2014 DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6)2013: 1. EXPELLED LEFT ESSURE DEVICE WITH PATENT LEFT FALLOPIAN TUBE. PATIENT WAS ADVISED OF THIS FINDING AND INFORMED THAT THE CURRENT ESSURE PLACEMENT IS NOT AN ADEQUATE FORM OF CONTRACEPTION. 2. RIGHT FALLOPIAN TUBAL OCCLUSION WITH APPROPRIATELY POSITIONED RIGHT ESSURE DEVICE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-APR-2019: QUALITY-SAFETY EVALUATION OF PTC. INCIDENT 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, 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 FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBE)") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A25165) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CO-SUSPECT PRODUCTS INCLUDED PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE EXPULSION "MIGRATION OF IMPLANT, EXPULSION OF ESSURE DEVICE,ESSURE FELL OUT DURING EXPULSION" (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED SPORTS INJURY AND MENSES DELAYED. CONCOMITANT PRODUCTS INCLUDED ETHINYLESTRADIOL;ETONOGESTREL (NUVARING) AND NORETHISTERONE (MICRONOR). ON AN UNKNOWN DATE, THE PATIENT STARTED PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS] AT AN UNSPECIFIED DOSE AND FREQUENCY. ON (B)(6)2013, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), TOOTH DISORDER ("DENTAL PROBLEMS") AND ALOPECIA ("HAIR LOSS"). IN 2014, THE PATIENT EXPERIENCED URINARY INCONTINENCE ("BLADDER OR URINARY PROBLEMS OR CHANGES: URINARY INCONTINENCE"). ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (B)(6)2014, BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2014. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE, MENORRHAGIA, URINARY INCONTINENCE, MIGRAINE, HEADACHE, NAUSEA, TOOTH DISORDER, ALOPECIA AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, FALLOPIAN TUBE PERFORATION, HEADACHE, MENORRHAGIA, MIGRAINE, NAUSEA, PREGNANCY WITH CONTRACEPTIVE DEVICE, TOOTH DISORDER, URINARY INCONTINENCE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TRAILING COIL. LEFT 2, RIGHT 3. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6)2013: 1. EXPELLED LEFT ESSURE DEVICE WITH PATENT LEFT FALLOPIAN TUBE. PATIENT WAS ADVISED OF THIS FINDING AND INFORMED THAT THE CURRENT ESSURE PLACEMENT IS NOT AN ADEQUATE FORM OF CONTRACEPTION. 2. RIGHT FALLOPIAN TUBAL OCCLUSION WITH APPROPRIATELY POSITIONED RIGHT ESSURE DEVICE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-JAN-2019: PFS RECEIVED EVENT "ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), URINARY INCONTINENCE, MIGRAINES HEADACHES, NAUSEA, DENTAL PROBLEMS, EXPULSION OF ESSURE DEVICE, PERFORATION (FALLOPIAN TUBE(S)), HAIR LOSS, ABDOMINAL PAIN" WERE ADDED. PATIENT, PRODUCT AND REPORTER INFORMATION WERE ADDED. LOT NUMBER AND LAB DATA WAS ADDED. MEDICAL HISTORY AND CONCOMITANT DRUG WAS ADDED. INCIDENT: WE RECEIVED A LOT NUMBER/RETURNED SAMPLE IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 1

    THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF IMPLANT") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". IN (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE THE ESSURE IMPLANT). ESSURE WAS REMOVED IN (B)(6) 2014. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION AND PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED DEVICE DISLOCATION AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. INCIDENT: NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. 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
    849444 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 A25165

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other| R MICRONOR,| MICRONOR.| NUVARING,| NUVARING,