BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5237103 · Received November 19, 2015

    Report

    Report Number
    2951250-2015-01629
    Event Type
    Injury
    Date Received
    November 19, 2015
    Date of Event
    October 19, 2016
    Report Date
    June 1, 2020
    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 · 1

    DATA CORRECTION: THE PRODUCT CODE KNH WAS REPLACED WITH HHS.

    Additional Manufacturer Narrative · 1

    CORRECTION ON 30-NOV-2015 FOLLOWING COMPANY INTERNAL CODING REVIEW: THE EVENT A GLUTEN, WHEAT, MILK, EGG, PEANUT, SOY AND SHRIMP ALLERGY WAS SPLIT TO MEDDRA LLT GLUTEN SENSITIVITY, AND MEDDRA LLT MILK ALLERGY AND MEDDRA LLT FOOD ALLERGY. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT IDENTIFIED DURING MONITORING OF POSTINGS ON AN FDA HOSTED DOCKET WEBSITE REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED HEADACHES AND HAD TO GO INTO THE HOSPITAL AND BE GIVEN MORPHINE BECAUSE THE PAIN WAS INTOLERABLE. SHE STATED SHE WILL BE CALLING HER GYNECOLOGIST AND HAVING THEM REMOVE THE ESSURE THE FIRST AVAILABLE; SHE STATED SHE TRULY BELIEVE ALL THIS IS BECAUSE OF THE ESSURE. THIS EVENT WAS CONSIDERED SERIOUS DUE TO HOSPITALIZATION AND LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. IN THIS CASE, CONSIDERING A POSITIVE TEMPORAL RELATIONSHIP AND BASED ON THE NATURE OF THE EVENT, CAUSALITY WITH SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE A SURGICAL INTERVENTION WILL BE REQUIRED. ADDITIONALLY, OTHER SERIOUS EVENTS (UNLISTED AND UNRELATED) AND NON-SERIOUS EVENTS WERE REPORTED. PRODUCT TECHNICAL COMPLAINT CONCLUDED THAT NO PRODUCT QUALITY DEFECT WAS CONFIRMED, THEREFORE A RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS AND A QUALITY DEFECT IS EXCLUDED. NO ACTIVE FOLLOW-UP WILL BE PURSUED, AS THIS CASE WAS IDENTIFIED DURING HEALTH AUTHORITY WEBSITE MONITORING.

    Description of Event or Problem · 1

    THIS CASE HAS BEEN IDENTIFIED DURING MONITORING OF POSTINGS ON AN FDA HOSTED DOCKET WEBSITE, WHICH HAS BEEN ESTABLISHED IN PREPARATION OF A PUBLIC FDA ADVISORY COMMITTEE WHICH TOOK PLACE IN SEPTEMBER 2015 (CASE# FDA-2014-N-0736-1681, AWARENESS DATE 23-OCT-2015) WHICH REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED IN (B)(6) 2010. ADDITIONAL INFORMATION RECEIVED ON 15-NOV-2015 (PTC INVESTIGATION RESULT). THE CONSUMER REPORTED ON (B)(6) 2011, SHE WAS AN EXTREMELY HEALTHY WOMAN AND NEVER HAD ANY ILLNESS. SHE STATED ONE MORNING SHE WAS HER WAY TO WORK AND BECOME VERY WEAK, SHE COULD NOT WALK AND WAS FEELING VERY SICK. SHE REPORTED HER HANDS AND FEET STARTED TO TURN A BLK /BLUE (RAYNAUDS SYNDROME) AND STARTED WITH COLD CHILL SWEATS FEVER. SHE BEGAN TO HAVE PROBLEMS BREATHING AND WAS TAKEN TO ER, WITHIN HOURS HER RESPIRATORY SYSTEM SHUT DOWN AND BECOME UNRESPONSIVE, SHE WAS PUT ON LIFE SUPPORT AND PUMPED LARGE AMOUNTS OF STEROIDS FOR AN INFECTIOUS DISEASE, AND SHE STATED A PHYSICIAN SAVED HER LIFE. SHE STAYED IN THE HOSPITAL FOR A MONTH AND WAS RELEASED WITH NO ANSWERS THEY HAD NO IDEA WHY THIS HAPPENED. SHE WAS UNABLE TO WALK DUE TO MUSCLE WEAKNESS FOR 5 TO 6 MONTHS. SHE WENT TO A RHEUMATOID SPECIALIST BECAUSE THEY KNEW THAT SHE HAD RAYNAUDS SYNDROME. THE SPECIALIST DIAGNOSED HER WITH AN AUTOIMMUNE DISEASE CALLED VASCULITIS, SHE WAS PUT ON CHEMO ONCE A WEEK FOR THE PAST 4 YEARS ONCE WEEKLY (METHOTREXATE, PREDNISONE) AND RECENTLY SHE HAD DEVELOPED A GLUTEN, WHEAT, MILK, EGG, PEANUT, SOY AND SHRIMP ALLERGY, WHEN SHE HAD EATEN ALL THESE FOODS HER WHOLE LIFE. SHE ALSO HAS HAD TO CHANGE HER TOILET PAPER SHAMPOO DEODORANT BECAUSE SHE ALSO DEVELOPED AN ALLERGY TO CERTAIN CHEMICALS. SHE WAS HAVING PROBLEMS WITH HER CYCLE, SHE WAS NOT HAVING ONE. SHE WENT TO HER GYNECOLOGIST WHICH HE WAS AWARE OF ALL MEDICATION AND THE REASON SHE WAS PUT ON ALL THESE MEDICATION, SHE ALSO LET HIM KNOW SHE HAD A TERMINAL AUTOIMMUNE DISEASE. SHE ASKED HIM IF HE THOUGHT IT HAD TO DO WITH THE ESSURE AND HE SAID NO, SHE STATED HE NEVER MENTIONED TO HER ALL THIS THAT WAS GOING ON WITH THE ESSURE. SHE REPORTED SHE HAS NICKEL ALLERGY EVER SINCE SHE WAS A LITTLE GIRL AND WAS NOT TESTED BEFORE THE ESSURE PROCEDURE. SHE ALSO REPORTED BEING TREATED FOR FIBROMYALGIA BECAUSE OF THE PAIN SHE WAS HAVING IN HER LEGS. SHE ALSO HAD MANY OTHER SIDE EFFECTS: PAIN, EXTREME FATIGUE, HEADACHES SHE HAD TO GO INTO THE HOSPITAL AND BE GIVEN MORPHINE BECAUSE THE PAIN WAS INTOLERABLE. SHE HAD ELEVATED BLOOD COUNTS AND RECENTLY JUST FOUND OUT ABOUT THIS AND ALL THAT HAS BEEN GOING. SHE STATED SHE WILL BE CALLING HER GYNECOLOGIST AND HAVING THEM REMOVE THE ESSURE THE FIRST AVAILABLE; SHE STATED SHE TRULY BELIEVE ALL THIS IS BECAUSE OF THE ESSURE. PTC INVESTIGATION RESULT: THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: PTC GLOBAL NUMBER (B)(4). FINAL ASSESSMENT: FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED. WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. FOR CASES WHERE AN INSERT IS REMOVED AT A LATER TIME AFTER INSERTION, WE TYPICALLY DO NOT CONDUCT AN INSPECTION OF THE INSERT. IN THIS CASE, NO PRODUCT WAS RETURNED. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ARTY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. MEDICAL ASSESSMENT: BASED ON THE AVAILABLE INFORMATION NO PRODUCT QUALITY DEFECT WAS CONFIRMED, THEREFORE A RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS AND A QUALITY DEFECT IS EXCLUDED. THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. COMPANY CAUSALITY COMMENT THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT IDENTIFIED DURING MONITORING OF POSTINGS ON AN FDA HOSTED DOCKET WEBSITE REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED HEADACHES AND HAD TO GO INTO THE HOSPITAL AND BE GIVEN MORPHINE BECAUSE THE PAIN WAS INTOLERABLE. SHE STATED SHE WILL BE CALLING HER GYNECOLOGIST AND HAVING THEM REMOVE THE ESSURE THE FIRST AVAILABLE; SHE STATED SHE TRULY BELIEVE ALL THIS IS BECAUSE OF THE ESSURE. THIS EVENT WAS CONSIDERED SERIOUS DUE TO HOSPITALIZATION AND LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. IN THIS CASE, CONSIDERING A POSITIVE TEMPORAL RELATIONSHIP AND BASED ON THE NATURE OF THE EVENT, CAUSALITY WITH SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE A SURGICAL INTERVENTION WILL BE REQUIRED. ADDITIONALLY, OTHER SERIOUS EVENTS (UNLISTED AND UNRELATED) AND NON-SERIOUS EVENTS WERE REPORTED. PRODUCT TECHNICAL COMPLAINT CONCLUDED THAT NO PRODUCT QUALITY DEFECT WAS CONFIRMED, THEREFORE A RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS AND A QUALITY DEFECT IS EXCLUDED. NO ACTIVE FOLLOW-UP WILL BE PURSUED, AS THIS CASE WAS IDENTIFIED DURING HEALTH AUTHORITY WEBSITE MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765272 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 678814

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| L| O| R ACETAMINOPHENE| ACETAMINOPHENE| ACETAMINOPHENE| ACETAMINOPHENE| GABAPENTIN| GABAPENTIN| GABAPENTIN| GABAPENTIN| INVANZ| INVANZ| INVANZ| INVANZ| LASIX [FUROSEMIDE]| LASIX [FUROSEMIDE]| LASIX [FUROSEMIDE]| LASIX [FUROSEMIDE]| METRONIDAZOLE| METRONIDAZOLE| METRONIDAZOLE| METRONIDAZOLE| PHENETURIDUM| PHENETURIDUM| PHENETURIDUM| PHENETURIDUM| VANCOMYCIN| VANCOMYCIN| VANCOMYCIN| VANCOMYCIN