BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7451267 · Received April 23, 2018

    Report

    Report Number
    2951250-2018-01934
    Event Type
    Injury
    Date Received
    April 23, 2018
    Report Date
    December 17, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE/ THEY COULDN'T FIND THE ONE ON THE RIGHT SIDE") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (NO COMPLICATIONS)") IN A 29-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE/ TUBAL PATENCY AFTER INSERTION OF ESSURE MICRO-INSERT/FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBES" IN JUNE 2011 AND DEVICE MONITORING PROCEDURE NOT PERFORMED "THE PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA (ON (B)(6) 2006, ON (B)(6) 2007, ON (B)(6) 2009, ON (B)(6) 2012), PARITY 4, ELEVATED BP, SWELLING OF LIMB, DYSPNEA, PRE-ECLAMPSIA, UTI AND IRRITABLE BOWEL SYNDROME. CONCURRENT CONDITIONS INCLUDED HERNIA, IRRITABLE BOWEL SYNDROME, MORBID OBESITY, SLEEP APNEA, TRICHOMONIASIS, VAGINAL ITCHING, TOOTHACHE, VULVOVAGINAL CANDIDA, FEVER, PREMATURE DELIVERY, BACK PAIN, LEG PAIN AND LOWER ABDOMINAL PAIN. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) IN MAY 2009 FOR BIRTH CONTROL AS WELL AS AMPICILLIN, FLUCONAZOLE, IRON SINCE 2015 AND LISINOPRIL FROM 2012 TO 2015. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN JUNE 2011, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("PAIN: ABDOMEN"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PREGNANCY WITH CONTRACEPTIVE DEVICE AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: PROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 5, PARA 4. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH OF A HEALTHY CHILD. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE DISLOCATION AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CONCOMITANT DRUG INCLUDED PRENATAL VITAMINS. ON (B)(6) 2012, FINDINGS REVEALED NORMAL TUBES, OVARIES AND UTERUS ON THE LEFT SIDE ESSURE NOTED AT THE CORNEA, RIGHT SIDE NO ESSURE FOUND. PATHOLOGY RIGHT AND LEFT TUBE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-NOV-2018: EVENT: PAIN: ABDOMEN WAS ADDED. DELIVERY DATE WAS UPDATED. 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.

    Additional Manufacturer Narrative · 0

    THIS PROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE/ THEY COULDN'T FIND THE ONE ON THE RIGHT SIDE") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (NO COMPLICATIONS)") IN A 29-YEAR-OLD FEMALE PATIENT (GRAVIDA 5, PARA 4) WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE/ TUBAL PATENCY AFTER INSERTION OF ESSURE MICRO-INSERT" IN (B)(6) 2011 AND DEVICE MONITORING PROCEDURE NOT PERFORMED "THE PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA AND PARITY 4. CONCURRENT CONDITIONS INCLUDED HERNIA, IRRITABLE BOWEL SYNDROME, MORBID OBESITY, SLEEP APNEA AND TRICHOMONIASIS. CONCOMITANT PRODUCTS INCLUDED IRON SINCE 2015, LISINOPRIL FROM 2012 TO 2015, MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) IN (B)(6) 2009 AND PRENATAL (PRENATAL VITAMINS [VIT C,B5,B12,D2,B3,B6,RETINOL PALMIT,B2,B1 MONONITR). ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION AND PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH OF A HEALTHY CHILD. THE REPORTER CONSIDERED DEVICE DISLOCATION AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS: ON (B)(6) 2012, FINDINGS REVEALED NORMAL TUBES, OVARIES AND UTERUS ON THE LEFT SIDE ESSURE NOTED AT THE CORNEA, RIGHT SIDE NO ESSURE FOUND. PATHOLOGY RIGHT AND LEFT TUBE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-JUN-2018: PLAINTIFF FACT SHEET RECEIVED. REPORTER INFORMATION, PATIENT¿S DEMOGRAPHIC INFORMATION, RELEVANT HISTORY UPDATED. EVENT THEY COULDN'T FIND THE ONE ON THE RIGHT SIDE WAS CLUBBED WITH PREVIOUSLY REPORTED EVENT. EVENTS DEVICE MONITORING PROCEDURE NOT PERFORMED WAS NEWLY ADDED. PREGNANCY OUTCOME UPDATED. 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.

    Additional Manufacturer Narrative · 0

    THIS PROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE/ THEY COULDN'T FIND THE ONE ON THE RIGHT SIDE") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (NO COMPLICATIONS)") IN A 29-YEAR-OLD FEMALE PATIENT (GRAVIDA 5, PARA 4) WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE/ TUBAL PATENCY AFTER INSERTION OF ESSURE MICRO-INSERT" IN (B)(6) 2011 AND DEVICE MONITORING PROCEDURE NOT PERFORMED "THE PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 4, ELEVATED BP, SWELLING OF LIMB, DYSPNEA, PRE-ECLAMPSIA, UTI AND IRRITABLE BOWEL SYNDROME. CONCURRENT CONDITIONS INCLUDED HERNIA, IRRITABLE BOWEL SYNDROME, MORBID OBESITY, SLEEP APNEA, TRICHOMONIASIS, VAGINAL ITCHING, TOOTHACHE, VULVOVAGINAL CANDIDA, FEVER, PREMATURE DELIVERY, BACK PAIN, LEG PAIN AND LOWER ABDOMINAL PAIN. CONCOMITANT PRODUCTS INCLUDED AMPICILLIN, FLUCONAZOLE, IRON SINCE 2015, LISINOPRIL FROM 2012 TO 2015 AND MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) IN (B)(6) 2009. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST, SECOND AND THIRD TRIMESTERS OF PREGNANCY. THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION AND PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH OF A HEALTHY CHILD. THE REPORTER CONSIDERED DEVICE DISLOCATION AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: CONCOMITANT DRUG INCLUDED PRENATAL VITAMINS. DIAGNOSTIC RESULTS: ON (B)(6) 2012, FINDINGS REVEALED NORMAL TUBES, OVARIES AND UTERUS ON THE LEFT SIDE ESSURE NOTED AT THE CORNEA, RIGHT SIDE NO ESSURE FOUND. PATHOLOGY RIGHT AND LEFT TUBE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-JUN-2018: QUALITY-SAFETY EVALUATION OF PTC. 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.

    Description of Event or Problem · 1

    THIS PROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (NO COMPLICATIONS)") IN A (B)(6) FEMALE PATIENT (GRAVIDA 5, PARA 4) WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE/ TUBAL PATENCY AFTER INSERTION OF ESSURE MICRO-INSERT" IN JUNE 2011. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA AND PARITY 4. CONCOMITANT PRODUCTS INCLUDED IRON SINCE 2015, LISINOPRIL FROM 2012 TO 2015 AND MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) IN (B)(6) 2009. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2011, THE PATIENT EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2012. 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-FEB-2018: PLAINTIFF FACT SHEET RECEIVED. NEW REPORTER, PATIENT DEMOGRAPHIC INFORMATION, RELEVANT HISTORY, LAB DATA AND CONCURRENT CONDITION, ESSURE INDICATION PERMANENT BIRTH CONTROL BY BILATERAL OCCLUSION OF THE FALLOPIAN TUBES WERE ADDED. THE EVENT INJURY WAS REPLACED WITH MIGRATION OF ESSURE DEVICE, PREGNANCY (NO COMPLICATIONS), FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBE(S). ESSURE LEGAL MANUFACTURER HAS CHANGED FROM BAYER HEALTHCARE, LLC, MILPITAS TO BAYER PHARMA AG, BERLIN, AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY. 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
    295337 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other| R AMPICILLIN| AMPICILLIN| AMPICILLIN| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| FLUCONAZOLE| FLUCONAZOLE| FLUCONAZOLE| IRON| IRON| IRON| IRON| IRON| LISINOPRIL| LISINOPRIL| LISINOPRIL| LISINOPRIL| LISINOPRIL| DEPO-PROVERA| IRON| LISINOPRIL