BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6177370 · Received December 15, 2016

    Report

    Report Number
    2951250-2016-02736
    Event Type
    Injury
    Date Received
    December 15, 2016
    Report Date
    April 17, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-MAR-2017: FURTHER INFORMATION IS NOT EXPECTED. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND HER INSERTS WERE TOO PUSHED INTO FALLOPIAN TUBES (INTERPRETED AS DEVICE DISLOCATION). SHE ALSO HAD ADENOMYOSIS AND UNDERWENT AN ENDOMETRECTOMY. SHE HAD POST-ENDOMETRECTOMY HEMORRHAGE. ESSURE REMOVAL IS SCHEDULED FOR 2017. DEVICE DISLOCATION AND POST PROCEDURAL HEMORRHAGE ARE ANTICIPATED EVENTS WHILE ADENOMYOSIS IS NOT ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. CONSIDERING THAT ESSURE INSERTS MAY MOVE ALONG THE FALLOPIAN TUBES AND THAT IN THIS CASE THERE IS NO ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. IN CONTRAST, CONSIDERING THE PHYSIOPATHOLOGY OF ADENOMYOSIS AND THE FACT THAT ESSURE HAS MAINLY A LOCALIZED ACTION IN THE FALLOPIAN TUBES, A CAUSAL RELATIONSHIP WITH ESSURE IS EXCLUDED. ALSO, SINCE THE HEMORRHAGE OCCURRED AFTER A PROCEDURE NOT RELATED TO ESSURE, THIS BLEEDING WAS ALSO ASSESSED AS NOT RELATED TO ESSURE. THIS CASE IS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WILL BE REQUIRED. PRODUCT TECHNICAL ANALYSIS WAS PERFORMED AS REVIEW OF THE MANUFACTURING BATCH RECORDS (COMPLAINT SAMPLE WAS NOT AVAILABLE). ACCORDING TO RESULTS, THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCTS MEET ALL RELEASE REQUIREMENTS. THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE; HOWEVER, A PLAUSIBLE RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. NO FURTHER INFORMATION IS EXPECTED.

    Additional Manufacturer Narrative · 1

    QUALITY-SAFETY EVALUATION OF PTC: THIS ADVERSE EVENT REPORT IS RELATED TO A PTC AND THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS (B)(4). LOT NUMBER 810874 (MANUFACTURING DATE: 2010/12 AND EXPIRATION DATE: 2013/12). SAMPLE NOT AVAILABLE. WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO FURTHER AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO THE REPORTED BATCH. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-DEC-2016: QUALITY-SAFETY EVALUATION OF PTC. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND HER INSERTS WERE TOO PUSHED INTO FALLOPIAN TUBES (INTERPRETED AS DEVICE DISLOCATION). SHE ALSO HAD ADENOMYOSIS AND UNDERWENT AN ENDOMETRECTOMY. SHE HAD POST-ENDOMETRECTOMY HEMORRHAGE. ESSURE REMOVAL IS SCHEDULED FOR 2017. DEVICE DISLOCATION AND POST PROCEDURAL HEMORRHAGE ARE ANTICIPATED EVENTS WHILE ADENOMYOSIS IS NOT ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. CONSIDERING THAT ESSURE INSERTS MAY MOVE ALONG THE FALLOPIAN TUBES AND THAT IN THIS CASE THERE IS NO ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. IN CONTRAST, CONSIDERING THE PHYSIOPATHOLOGY OF ADENOMYOSIS AND THE FACT THAT ESSURE HAS MAINLY A LOCALIZED ACTION IN THE FALLOPIAN TUBES, A CAUSAL RELATIONSHIP WITH ESSURE IS EXCLUDED. ALSO, SINCE THE HEMORRHAGE OCCURRED AFTER A PROCEDURE NOT RELATED TO ESSURE, THIS BLEEDING WAS ALSO ASSESSED AS NOT RELATED TO ESSURE. THIS CASE IS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WILL BE REQUIRED. PRODUCT TECHNICAL ANALYSIS WAS PERFORMED AS REVIEW OF THE MANUFACTURING BATCH RECORDS (COMPLAINT SAMPLE WAS NOT AVAILABLE). ACCORDING TO RESULTS, THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCTS MEET ALL RELEASE REQUIREMENTS. THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE; HOWEVER, A PLAUSIBLE RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. FURTHER INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A FEMALE CONSUMER OF UNSPECIFIED AGE VIA REGULATORY AUTHORITY ((B)(4)) IN (B)(6) ON 21-NOV-2016 WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED IN (B)(6) 2011. THE DISTANCE BETWEEN DISTAL PARTS OF EACH ESSURE INSERT WAS TOO IMPORTANT, INSERTS WERE TOO PUSHED INTO FALLOPIAN TUBES. THE CONSUMER EXPERIENCED BLEEDING BETWEEN MENSTRUATIONS 6 MONTHS AFTER ESSURE INSERTION WHICH GOT MORE AND MORE SIGNIFICANT UNTIL HEMORRHAGE IN 2013. SHE WAS TAKING EXACYL AND LUTENYL WITH BAD TOLERANCE. SHE UNDERWENT ENDOMETRECTOMY FOLLOWING DISCLOSURE OF ADENOMYOSIS VIA MRI (MAGNETIC RESONANCE IMAGING). EXAMINATION OF UTERUS FRAGMENTS FOUND POLYP IN UTERINE WALL. CLINICAL CONSEQUENCES SINCE ENDOMETRECTOMY WERE THE FOLLOWING: LESS PAINFUL AND LESS LONG MENSTRUATIONS AND NO MORE PAIN DURING INTERCOURSES. HOWEVER, SINCE 2014 THE CONSUMER EXPERIENCED CHRONIC LOWER BACK PAIN AGGRAVATED DURING MENSTRUATIONS WITH IMPOSSIBILITY OF WALKING OR MOVING FOR HALF DAY. SHE ALSO EXPERIENCED CHRONIC FATIGUE, MUSCULAR PAIN, DIGESTIVE DISORDERS WITH CONSTIPATION, PAIN DURING DEFECATION AND BLOATING. SHE EXPERIENCED WEIGHT GAIN OF 5 KG SINCE 2011. THE CONSUMER REPORTED THE FOLLOWING ACTIONS TAKEN: ENDOMETRECTOMY ON (B)(6) 2014 AND COLOSCOPY ON (B)(6) 2016. THE PATIENT LISTED ALL THE EVENTS SHE EXPERIENCED OR WAS STILL EXPERIENCING (OCCASIONAL OR CHRONIC EVENTS): CHRONIC FATIGUE, DIZZINESS, FEELING OF DRUNKENNESS, HEMORRHAGIC MENSTRUATIONS, BLEEDING BETWEEN MENSTRUATIONS (BEFORE ENDOMETRECTOMY), HEMORRHAGE POST-ENDOMETRECTOMY, POLYP IN UTERINE WALL (BEFORE ENDOMETRECTOMY, ADENOMYOSIS, FREQUENT NEED TO URINATE, RECURRENT FUNCTIONAL CYSTS, SWOLLEN ABDOMEN / BLOATING, SYMPTOMS WORSENING DURING PREMENSTRUAL PERIOD AND DURING MENSTRUATIONS, WEIGHT GAIN, LOWER BACK PAIN (LUMBAR/DORSAL PAIN), MUSCULAR PAIN WHICH PERIODICALLY GOT GENERALIZED (LEGS, ARMS), MIGRAINES DURING MENSTRUATIONS, MEMORY LOSS, AND BELLY PAIN. AGGRAVATING FACTOR OF THESE EVENTS WAS CONSUMER'S STRESS. ESSURE REMOVAL WAS PLANNED TO BE PERFORMED IN 2017. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND HER INSERTS WERE TOO PUSHED INTO FALLOPIAN TUBES (INTERPRETED AS DEVICE DISLOCATION). SHE ALSO HAD ADENOMYOSIS AND UNDERWENT AN ENDOMETRECTOMY. SHE HAD POST-ENDOMETRECTOMY HEMORRHAGE. ESSURE REMOVAL IS SCHEDULED FOR 2017. DEVICE DISLOCATION AND POST PROCEDURAL HEMORRHAGE ARE ANTICIPATED EVENTS WHILE ADENOMYOSIS IS NOT ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. CONSIDERING THAT ESSURE INSERTS MAY MOVE ALONG THE FALLOPIAN TUBES AND THAT IN THIS CASE THERE IS NO ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. IN CONTRAST, CONSIDERING THE PHYSIOPATHOLOGY OF ADENOMYOSIS AND THE FACT THAT ESSURE HAS MAINLY A LOCALIZED ACTION IN THE FALLOPIAN TUBES, A CAUSAL RELATIONSHIP WITH ESSURE IS EXCLUDED. ALSO, SINCE THE HEMORRHAGE OCCURRED AFTER A PROCEDURE NOT RELATED TO ESSURE, THIS BLEEDING WAS ALSO ASSESSED AS NOT RELATED TO ESSURE. THIS CASE IS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WILL BE REQUIRED. A PRODUCT TECHNICAL COMPLAINT ANALYSIS IS BEING SOUGHT. FURTHER INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825701 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 810874

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R EXACYL (TRANEXAMIC ACID)| LUTENYL (NOMEGESTROL ACETATE)