BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3954612 · Received July 17, 2014

    Report

    Report Number
    2951250-2014-00290
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    May 1, 2013
    Report Date
    October 22, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION (B)(6)-2014 FOLLOWING COMPANY INTERNAL CODING REVIEW: THE EVENT "CHRONIC INFLAMMATION OF GALLBLADDER" WAS RECODED TO MEDRA LLT "CHRONIC CHOLECYSTITIS". FOLLOW-UP FROM (B)(6)-2014: FOLLOW-UP ATTEMPTS HAVE BEEN MADE, WITH NO RESPONSE TO DATE. PTC INVESTIGATION RESULT WAS RECEIVED ON (B)(6)-2014. THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: PTC LOCAL NUMBER (B)(4) AND PTC GLOBAL NUMBER (B)(4). FINAL ASSESSMENT: 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 CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR AN INSPECT THE DEVICE 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 AT THIS TIME. MEDICAL ASSESSMENT: THE MEDICAL EVENTS REPORTED ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. FIVE (5) ADDITIONAL AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO BATCH NUMBER 628441 BUT NONE OF THESE CASES REFER TO A SIMILAR TYPE OF MEDICAL EVENT. NO BATCH SIGNAL COULD BE IDENTIFIED AT THIS TIME. THE REVIEW OR THE LOT HISTORY RECORDS CONFIRMED THAT THE PRODUCT MET PRODUCT RELEASE SPECIFICATIONS. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. AT THE TIME OF THIS MEDICAL ASSESSMENT THE TECHNICAL INVESTIGATION CONCLUDED "UNCONFIRMED QUALITY DEFECT". BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT. THIS NON MEDICALLY-CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED PELVIC PAIN, THE LEFT SIDE COIL WAS FOUND IN THE FAFFI TISSUE OF THE ABDOMEN, AN X-RAY SHOWED THE COIL WAS IN THE RIGHT UPPER QUADRANT ("WHERE MY GALLBLADDER WAS") AND CHRONIC INFLAMMATION OF GALLBLADDER. THE REPORTED EVENTS WERE CONSIDERED SERIOUS, AS MEDICALLY SIGNIFICANT AND ARE LISTED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE EXCEPT FOR CHRONIC INFLAMMATION OF GALLBLADDER WHICH IS UNLISTED. PELVIC AND ABDOMINAL PAIN MAY OCCUR WITH ESSURE THERAPY. IN THIS PARTICULAR CASE THE CONSUMER STATED THAT SHE HAD A HYSTERECTOMY DUE TO PELVIC PAIN, AND THAT ESSURE MIGRATED OUT OF HER FALLOPIAN TUBES; THE LEFT SIDE MIGRATION WAS DIAGNOSED BEFORE HER HYSTERECTOMY. GIVEN THIS INFORMATION CAUSALITY BETWEEN THE SUSPECT INSERT AND THE REPORTED PELVIC PAIN AND INSERT MIGRATION ON LEFT SIDE CANNOT BE EXCLUDED AND DUE TO THE REPORTED HYSTERECTOMY THEY WERE CONSIDERED INCIDENTS. REGARDING X-RAY SHOWED THE COIL WAS IN THE RIGHT UPPER QUADRANT ("WHERE MY GALLBLADDER WAS'), INTERPRETED AS A MIGRATION OF THE RIGHT ESSURE COIL, GIVEN ITS NATURE IT WAS CONSIDERED AS RELATED TO ESSURE. THIS EVENT WAS REGARDED AS A NON-INCIDENT, SINCE IT WAS REPORTED AS A RECENT DIAGNOSIS AND NO INTERVENTION OR INJURY WAS MENTIONED OR ASSIGNED TO THIS EVENT UNTIL THE TIME OF THIS REPORT. THE CONSUMER ALSO STATED THAT BEFORE HER HYSTERECTOMY SHE HAD HER GALLBLADDER REMOVED (CHOLECYSTECTOMY) AND IT SHOWED CHRONIC INFLAMMATION. CONSIDERING THAT MOST OF CHOLECYSTECTOMIES ARE PERFORMED DUE TO SYMPTOMS OR COMPLICATIONS RELATED TO GALLSTONES AND GIVEN ESSURE'S LOCAL ACTION AT FALLOPIAN TUBES, THE EVENT CHRONIC INFLAMMATION OF GALLBLADDER WAS CONSIDERED AS UNRELATED TO ESSURE, AND A THUS A NON-INCIDENT. IN ADDITION, NON-SERIOUS EVENTS WERE REPORTED. PTC ANALYSIS CONCLUDED, AT THE TIME OF THIS MEDICAL ASSESSMENT THE TECHNICAL INVESTIGATION CONCLUDED "UNCONFIRMED QUALITY DEFECT". BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT. FOLLOW-UP INFORMATION IS BEING SOUGHT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A CONSUMER IN UNITED STATES ON (B)(6)-2014 WHICH REFERS TO HERSELF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) AND EXPERIENCED THE FOLLOWING EVENTS. ESSURE DEVICES WERE INSERTED ON (B)(6)-2009; THE LOT NUMBER USED WAS 628441. CONSUMER REPORTED THAT ESSURE MIGRATED OUT OF HER FALLOPIAN TUBES ON BOTH SIDES. THE ESSURE OF LEFT SIDE WAS FOUND IN THE FATTY TISSUE OF THE ABDOMEN. ON (B)(6) 2013, SHE HAD A HYSTERECTOMY DONE BECAUSE OF PELVIC PAIN. THE LEFT COIL WAS DISCOVERED OUT OF PLACE BEFORE THE SURGERY. THE HYSTERECTOMY SHOWED ENDOMETRIOSIS AND VARICOSE VEINS ON HER UTERUS. AT THE TIME, THEY THOUGHT THAT THEY ALSO REMOVED THE RIGHT COIL. ON (B)(6)-2014, SHE WENT BACK TO HER PHYSICIAN DUE TO A BACK TROUBLE. AN X-RAY WAS DONE AND SHOWED A COIL IN THE UPPER QUADRANT, BY THE RIBS WHERE HER GALLBLADDER WAS. CONSUMER STATED THAT SHE WAS FEELING A ''PINCHING'' IN THE SIDE. CONSUMER ALSO REPORTED THAT IN 2012 SHE HAD HER GALLBLADDER REMOVED BECAUSE OF CONSTANT SIDE PAINS, AND IT SHOWED CHRONIC INFLAMMATION. SHE HAD A SCAN IN 2009 WHICH CAME UP AS ''FUNCTIONING''. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420132 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 628441

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other| R YAZ| YAZ