BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4928600 · Received July 21, 2015

    Report

    Report Number
    2951250-2015-00524
    Event Type
    Injury
    Date Received
    July 21, 2015
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS

    Additional Manufacturer Narrative · 1

    FOLLOW-UP FROM 01 OCT 2015: THE REQUIRED NUMBER OF FOLLOW-UP ATTEMPTS HAVE BEEN COMPLETED, WITH NO RESPONSE TO DATE. NO FURTHER FOLLOW-UP WILL BE PURSUED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A FEMALE CONSUMER OF UNSPECIFIED AGE VIA REGULATORY AUTHORITY (MW# 5041960) IN UNITED STATES ON (B)(6) 2015 WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) LOT NUMBER 855628 INSERTED ON (B)(6) -2011. ABOUT ONE YEAR AFTER THEM BEING IMPLANTED SHE STARTED HAVING SEVERE SIDE EFFECTS. SHE SUFFERED FROM EXTREME PAIN WHILE OVULATING EACH MONTH AND HAD TROUBLE WITH EVERYDAY TASK. THE OVULATING PAIN WOULD LAST FOR ABOUT A WEEK SOMETIMES LONGER. THEN SHE WOULD BE UNCOMFORTABLE AND EXTREMELY BLOATED ONLY TO THEN HAVE EXTREME PAIN AGAIN THE WEEK BEFORE HER PERIOD. THE EXTREME PAIN WOULD BE ABOUT 3 WEEKS OUT OF THE MONTH. THE PAIN WAS MAKING HER DEPRESSED AND IRRITABLE ALL THE TIME. SHE ALSO GAINED 30 POUNDS SINCE HAVING THE ESSURE IMPLANTED. A MRI (NUCLEAR MAGNETIC RESONANCE IMAGING) WAS PERFORMED AND SHOWED ESSURE DEVICES WERE STILL CORRECTLY IN PLACE. CONSUMER HAD TUBES REMOVED WITH THE ESSURE DEVICES ON (B)(6) 2014. THE SURGERY WENT WELL, BUT THE FIRST MENSTRUAL CYCLE AFTER HAVING THEM REMOVED SHE HAD HEAVY BLEEDING. TO DATE SHE WAS STILL EXPERIENCING EXTREMELY HEAVY CYCLES, BLOOD CLOTS THROUGHOUT HER CYCLE AND SHE ALSO DEVELOPED OVARIAN CYSTS SINCE ESSURE REMOVAL. SHE WAS ABOUT TO HAVE AN ENDOMETRIAL ABLATION TO SEE IF SHE GETS ANY RELIEF OF MY HEAVY MENSTRUAL CYCLES. SHE WAS ALSO DEALING WITH ANEMIA. CONSUMER ASSESSED EVENT OUTCOME AS DISABILITY OR PERMANENT DAMAGE; HOWEVER SHE DID NOT SPECIFY IT. FOLLOW-UP RECEIVED ON (B)(6) -2015: PRODUCT TECHNICAL COMPLAINT INVESTIGATION AND FINAL ASSESSMENT WERE RECEIVED: THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT AND WAS INITIATED DUE TO A REQUEST FOR CONFIRMATION OF QUALITY. THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS (B)(6) AND THE LOCAL NUMBER IS (B)(4). FINAL ASSESSMENT: LOT NUMBER: 855628; PRODUCTION DATE: (B)(6) 2011; EXPIRATION DATE: APR-2014. SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. IN THIS CASE, 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. NO NEW FAILURE MODE HAS BEEN IDENTIFIED. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A REQUEST FOR CONFIRMATION OF QUALITY. THE REPORTED ADVERSE EVENTS CONSIDERED RELATED ARE KNOWN POSSIBLE UNDESIRABLE EVENTS AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO SIMILAR AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO THE REPORTED BATCH. NO BATCH SIGNAL COULD BE IDENTIFIED. THE BATCH DOCUMENTATION OF THE REPORTED BATCH WAS REVIEWED. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT.. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED EXTREMELY BLOATED. THIS EVENT WAS CONSIDERED SERIOUS DUE TO MEDICAL IMPORTANCE AND LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. IN THIS CASE, ABOUT ONE YEAR AFTER ESSURE INSERTION, SHE STARTED HAVING SEVERE SIDE EFFECTS. IT WAS REPORTED THAT A MRI (NUCLEAR MAGNETIC RESONANCE IMAGING) WAS PERFORMED AND THE RESULT SHOWED ESSURE DEVICES WERE STILL CORRECTLY IN PLACE. CONSUMER HAD TUBES REMOVED WITH THE ESSURE DEVICES. GIVEN THE EVENT'S NATURE, A CAUSAL RELATIONSHIP BETWEEN THE EVENT AND SUSPECT INSERT CANNOT BE EXCLUDED. DUE TO REQUIRED INTERVENTION, THIS CASE WAS REGARDED AS INCIDENT. ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. THE PRODUCT TECHNICAL ANALYSIS CONCLUDED THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. FURTHER INFORMATION IS BEING SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471356 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 855628

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R