BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7107313 · Received December 12, 2017

    Report

    Report Number
    2951250-2017-10555
    Event Type
    Injury
    Date Received
    December 12, 2017
    Date of Event
    December 1, 2016
    Report Date
    August 16, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE: LEFT COIL WAS NOTED TO BE LOCATED IN THE EPIPLOIC AT THE DESCENDING COLON"), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("ECTOPIC PREGNANCY") AND PELVIC PAIN ("PELVIC PAIN") IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893029) 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" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERWENT ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED MULTIGRAVIDA AND PARITY 2 (B)(6) 2007, (B)(6) 2012). CONCOMITANT PRODUCTS INCLUDED ANTIBIOTICS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED DYSGEUSIA ("METALLIC TASTE IN HER MOUTH"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE"). IN 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION") AND VAGINAL INFECTION ("VAGINAL INFECTION"). IN 2015, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE HEADACHES"). IN (B)(6) 2016, THE PATIENT EXPERIENCED DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLES"). ON (B)(6) 2016, 4 YEARS 1 MONTH AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"). IN (B)(6) 2016, THE PATIENT EXPERIENCED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), VAGINAL HAEMORRHAGE ("HEAVY VAGINAL BLEEDING"), HEADACHE ("HEADACHES") AND ABDOMINAL PAIN LOWER ("LOWER LEFT SIDE ABDOMEN PAIN"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (UNILATERAL SALPINGECTOMY- DIAGNOSTIC LAPAROSCOPY AND LEFT SALPINGECTOMY AND REMOVAL OF LEFT ESSURE) AND SURGERY (UNDERWENT PROCEDURE TO REMOVE THE ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, MIGRAINE, DYSGEUSIA, BACK PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, FATIGUE, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, HEADACHE, ABDOMINAL DISTENSION AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BACK PAIN, CYSTITIS, DEVICE DISLOCATION, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, FATIGUE, HEADACHE, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT SOUGHT TREATMENT FOR HER SYMPTOMS. DIAGNOSTIC RESULTS: THE RIGHT OSTIA CANNULATED WITH ESSURE DEVICE AND MULTIPLE COILS WERE VISUALIZED AFTERWARDS. LEFT OSTIA VISUALIZED AND ESSURE DEVICE PLACED, TWO COILS PRESENT AFTER CANNULATION QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-AUG-2018: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. 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.

    Additional Manufacturer Narrative · 0

    THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE: LEFT COIL WAS NOTED TO BE LOCATED IN THE EPIPLOIC AT THE DESCENDING COLON"), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("ECTOPIC PREGNANCY") AND PELVIC PAIN ("PELVIC PAIN") IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893029) 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" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERWENT ESSURE CONFIRMATION TEST". THE PATIENT'S CONCURRENT CONDITIONS INCLUDED MULTIGRAVIDA AND PARITY 2 ((B)(6) 2007, (B)(6) 2012). CONCOMITANT PRODUCTS INCLUDED ANTIBIOTICS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED DYSGEUSIA ("METALLIC TASTE IN HER MOUTH"). IN (B)(6) 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("PAINFUL INTERCOURSE"). IN 2013, THE PATIENT EXPERIENCED VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), CYSTITIS ("BLADDER INFECTION"), URINARY TRACT INFECTION ("URINARY TRACT INFECTION") AND VAGINAL INFECTION ("VAGINAL INFECTION"). IN 2015, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINE HEADACHES"). IN (B)(6) 2016, THE PATIENT EXPERIENCED DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLES"). ON (B)(6) 2016, 4 YEARS 1 MONTH AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED ABDOMINAL DISTENSION ("BLOATING"). IN (B)(6) 2016, THE PATIENT EXPERIENCED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), VAGINAL HAEMORRHAGE ("HEAVY VAGINAL BLEEDING"), HEADACHE ("HEADACHES") AND ABDOMINAL PAIN LOWER ("LOWER LEFT SIDE ABDOMEN PAIN"). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (UNILATERAL SALPINGECTOMY- DIAGNOSTIC LAPAROSCOPY AND LEFT SALPINGECTOMY AND REMOVAL OF LEFT ESSURE) AND SURGERY (UNDERWENT PROCEDURE TO REMOVE THE ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, MIGRAINE, DYSGEUSIA, BACK PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE, FATIGUE, CYSTITIS, URINARY TRACT INFECTION, VAGINAL INFECTION, HEADACHE, ABDOMINAL DISTENSION AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BACK PAIN, CYSTITIS, DEVICE DISLOCATION, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, FATIGUE, HEADACHE, MIGRAINE, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT SOUGHT TREATMENT FOR HER SYMPTOMS. DIAGNOSTIC RESULTS: THE RIGHT OSTIA CANNULATED WITH ESSURE DEVICE AND MULTIPLE COILS WERE VISUALIZED AFTERWARDS. LEFT OSTIA VISUALIZED AND ESSURE DEVICE PLACED, TWO COILS PRESENT AFTER CANNULATION MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-APR-2018: PLAINTIFF FACT SHEET- ALL RELEVANT MEDICAL HISTORY CONDITION, CONCURRENT CONDITION, CONCOMITANT MEDICATION AND EVENTS FATIGUE, BLADDER INFECTION, URINARY TRACT INFECTION, VAGINAL INFECTION, HEADACHES, ABDOMINAL DISTENSION, ABDOMINAL PAIN LOWER, DEVICE MONITORING PROCEDURE NOT PERFORMED 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.

    Description of Event or Problem · 1

    THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("ECTOPIC PREGNANCY") AND PELVIC PAIN ("PELVIC PAIN") IN A 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". ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2016, THE PATIENT EXPERIENCED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("PAINFUL MENSTRUAL CYCLES"), DYSPAREUNIA ("PAINFUL INTERCOURSE"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), MIGRAINE ("MIGRAINE HEADACHES"), DYSGEUSIA ("METALLIC TASTE IN HER MOUTH"), BACK PAIN ("BACK PAIN"), VAGINAL DISCHARGE ("IRREGULAR VAGINAL DISCHARGE") AND VAGINAL HAEMORRHAGE ("HEAVY VAGINAL BLEEDING"). 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 (UNDERWENT PROCEDURE TO REMOVE THE ESSURE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, PELVIC PAIN, DYSMENORRHOEA, DYSPAREUNIA, ABDOMINAL PAIN, MIGRAINE, DYSGEUSIA, BACK PAIN, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DYSGEUSIA, DYSMENORRHOEA, DYSPAREUNIA, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, MIGRAINE, PELVIC PAIN, VAGINAL DISCHARGE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT SOUGHT TREATMENT FOR HER SYMPTOMS. 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
    887162 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 893029

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other| R ANTIBIOTICS| ANTIBIOTICS