BEUDAMED
    FDA Adverse Event Summary report: N

    ESSURE

    MDR report key: 3872079 · Received May 29, 2014

    Report

    Report Number
    2951250-2014-00186
    Date Received
    May 29, 2014
    Date of Event
    January 1, 2010
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: FINAL ASSESSMENT: WHEN THE TERMS "BREAK," "BREAKAGE," "BROKE," "BROKEN," "FALLING APART," OR "SPLIT" ARE USED WHEN DESCRIBING A DEVICE EVENT, IT IS DIFFICULT TO DETERMINE THE TRUE NATURE OF THE EVENT FROM THE COMPLAINT DESCRIPTION ALONE. UNLESS ADDITIONAL DETAIL IS PROVIDED IN THE EVENT DESCRIPTION, IT IS DIFFICULT TO DETERMINE IF THE REPORTER IS DESCRIBING AN EVENT WHERE THE MICRO INSERT ACTUALLY BROKE INTO INDIVIDUAL PIECES, OR IF THE MICRO-INSERT BENT OR STRETCHED INTO AN UNINTENDED SHAPE, AND HENCE WAS CONSIDERED BY THE REPORTER TO BE "BROKEN." FAILURE MODE/MECHANISM THE ESSURE INSERT IS MADE UP OF A FLEXIBLE OUTER COIL THAT IS DEPLOYED INTO THE FALLOPIAN TUBE. THE INSERT'S OUTER COILS EXPAND TO CONFORM TO THE FALLOPIAN TUBE, ACUTELY ANCHORING ITSELF UNTIL THE INSERT ELICITS TISSUE INGROWTH. AFTER THE FIRST ROLL BACK IS COMPLETED AND THE BUTTON IS PRESSED, USER ATTEMPTS TO REPOSITION THE DEVICE COULD LEAD TO DETACHMENT DIFFICULTY, PREMATURE DEPLOYMENT, OR IMPROPER DEVICE FUNCTION. IF THE OUTER COILS OF THE MICRO-INSERT PARTIALLY DEPLOY DURING USER ATTEMPTS TO REPOSITIONING THE DEVICE AND THE COIL CATHETER IS NOT FULLY RETRACTED, THE OUTER COILS OF THE MICRO-INSERT COULD BECOME ENTANGLED WITHIN THE DISTAL PORTION OF THE COIL CATHETER. IF THE OUTER COILS ARE PARTIALLY DEPLOYED, THE INSERT WILL BEGIN TO ANCHOR ITSELF TO THE FALLOPIAN TUBE. IF THE INNER COIL IS STILL AFFIXED TO THE DELIVERY WIRE BECAUSE ALL IFU STEPS HAVE NOT YET BEEN COMPLETED, SUBSEQUENT ATTEMPTS BY THE USER TO REMOVE THE CATHETER ASSEMBLY MAY LEAD TO EITHER A STRETCHING OF THE MICROINSERT, STRETCHING OF THE INNER CATHETER LARGE TIGHT PITCH COIL, OR BREAKAGE OF THE LARGE TIGHT PITCH COIL. IF THE PHYSICIAN ATTEMPTS TO REMOVE A DEPLOYED MICRO-INSERT THAT IS LOCATED WITHIN THE FALLOPIAN TUBE BY PULLING ON THE OUTER COIL OF THE MICRO-INSERT WITH A GRASPER, THIS ACTION COULD ALSO LEAD TO BREAKAGE OF THE OUTER COIL OF THE MICROINSERT. 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, OUTER CATHETER, THE INNER CATHETER, AND ALL PARTS WITHIN THE HANDLE ASSEMBLY TO CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR AND INSPECT THE DEVICE TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. 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 ANY QUALITY DEFECT AT THIS TIME. CONCLUSIONS THE REPORT DID NOT STATE A PATIENT INJURY OCCURRED. IN ADDITION, THE INFORMATION AVAILABLE SUGGESTS THAT IF THIS ISSUE WERE TO RECUR, THE DEVICE WOULD NOT LIKELY CAUSE A DEATH OR SERIOUS INJURY. ACCORDING TO THE DFMEA, THE MAIN CONSEQUENCE IS THAT THE PROCEDURE COULD BE ABORTED, RESCHEDULED OR THE USE OF ALTERNATIVE INTERVENTION MAY BE NECESSARY. MEDICAL ASSESSMENT: THE MEDICAL EVENTS REPORTED ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. LACK OF EFFECTIVENESS IS NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT AS IT MAY OCCUR WITH THE USE OF ANY PRODUCT. ADDITIONALLY, PREGNANCY MAY OCCUR DURING ANY CONTRACEPTIVE USE. THIS CASE ALSO REPORTED DEVICE EVENTS OF EXPULSION, DISLOCATION, AND BREAKAGE WHICH ARE POSSIBLE UNDESIRABLE EVENTS WITH THE USE OF ESSURE AND ALSO NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. NO BATCH NUMBER WAS REPORTED. NEITHER A TECHNICAL BATCH INVESTIGATION NOR A BATCH CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE WITHOUT A BATCH NUMBER. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ONE COIL MIGRATED AND BROKE OFF AND WAS IN THE OMENTUM [DEVICE BREAKAGE]. PELVIC PAIN [PELVIC PAIN]. ESSURE COILS WERE POKING THROUGH THE FUNDUS OF UTERUS [EMBEDDED DEVICE]. ONE COIL MIGRATED AND BROKE OFF AND WAS IN THE OMENTUM [DEVICE DISLOCATION INTO ABDOMINAL CAVITY]. NICKEL ALLERGIES [NICKEL SENSITIVITY]. FATIGUE [FATIGUE]. BECAME PREGNANT [PREGNANCY WITH CONTRACEPTIVE DEVICE]. DEVICE INEFFECTIVE [DEVICE INEFFECTIVE]. ESSURE COILS WERE POKING THROUGH THE FUNDUS OF UTERUS [PARTIAL EXPULSION OF DEVICE]. ONE SIDE ERODING THROUGH THE TUBE [EMBEDDED DEVICE]. CASE DESCRIPTION: CASE SUMMARY: SERIOUS, LISTED, RELATED (INCIDENT). THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A PHYSICIAN IN UNITED STATES ON (B)(4) 2014. IT DESCRIBES THE OCCURRENCE OF BECAME PREGNANT, DEVICE INEFFECTIVE, PELVIC PAIN, FATIGUE, ESSURE COILS WERE POKING THROUGH THE FUNDUS OF UTERUS, ESSURE COILS WERE POKING THROUGH THE FUNDUS OF UTERUS, ONE SIDE ERODING THROUGH THE TUBE, ONE COIL MIGRATED AND BROKE OFF AND WAS IN THE OMENTUM, ONE COIL MIGRATED AND BROKE OFF AND WAS IN THE OMENTUM, AND NICKEL ALLERGIES IN A FEMALE PATIENT OF UNSPECIFIED AGE WHO RECEIVED ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) . NO INFORMATION GIVEN ON PATIENT'S HISTORY, PAST DRUGS AND CONCURRENT CONDITIONS. IT WAS NOT REPORTED WHETHER THE PATIENT RECEIVED ANY CONCOMITANT MEDICATION. IN 2008, THE PATIENT HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED FOR PERMANENT BIRTH CONTROL. IT WAS UNKNOWN WHETHER ESSURE WAS USED PREVIOUSLY. ON UNSPECIFIED DATE, THE 3 MONTHS HSG (HYSTEROSALPINGOGRAPHY) WAS CONFIRMED. AFTER PROCEDURE THE PATIENT BECAME PREGNANT AND HAD A BABY (BORN IN 2008). THE PATIENT WAS EXPERIENCING PELVIC PAIN AND FATIGUE, THE PHYSICIAN PERFORMED A LAPAROSCOPY IN 2010 AND SAW ESSURE COILS WERE POKING THROUGH THE FUNDUS OF UTERUS AND ONE SIDE ERODING THROUGH TUBE. PHYSICIAN OFFERED TO REMOVE THE ESSURE DEVICE AND DO AN HYSTERECTOMY BUT THE PATIENT WANTED TO WAIT. ON (B)(6) 2014, PHYSICIAN HAD A HYSTERECTOMY PERFORMED. ONE OF THE ESSURE COILS MIGRATED AND BROKE OFF AND WAS IN THE OMENTUM. PHYSICIAN ALSO MENTIONED THAT THE PATIENT COMPLAINT OF NICKEL ALLERGIES 1-2 YEARS AGO (FROM TIME OF REPORT). REPORTER CAUSALITY: THE RELATIONSHIP BETWEEN THE EVENTS AND ESSURE WAS NOT REPORTED. FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2014: PRODUCT TECHNICAL COMPLAINT (PTC) INVESTIGATION RESULT RECEIVED. PTC GLOBAL NUMBER IS (B)(4). FOLLOW-UP (B)(4) 2014: REPORTER DID NOT ANSWER TO FOLLOW-UP REQUESTS UP TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316706 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other