BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 4210554 · Received October 29, 2014

    Report

    Report Number
    2951250-2014-00468
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP FROM (B)(6) 2015: THE REQUIRED NUMBER OF FOLLOW-UP ATTEMPTS HAS BEEN COMPLETED, WITH NO RESPONSE TO DATE. NO FURTHER FOLLOW-UP WILL BE PURSUED. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A (B)(6)-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND IT WAS REPORTED THAT THE PHYSICIAN WENT TO DEPLOY IT, A PORTION OF THE DEVICE BROKE OFF. THIS EVENT, INTERPRETED AS DEVICE BREAKAGE, IS NON-SERIOUS AND LISTED FOR ESSURE ACCORDING TO TECHNICAL ANALYSIS. DURING DIFFICULT INSERTION/REMOVALS, SINGLE CASES HAVE BEEN REPORTED OF ESSURE BREAKAGE. IN THIS PARTICULAR CASE, THE DEVICE BREAKAGE OCCURRED DURING ESSURE INSERTION. PHYSICIAN STATED THAT THREE COILS (THE BROKEN PIECE) WERE EXTRACTED FROM UTERINE CAVITY AND PATIENT HAD SUCCESSFUL PLACEMENT ON ONE SIDE. THEREFORE, A CAUSAL RELATIONSHIP BETWEEN THE REPORTED EVENT AND ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS OTHER REPORTABLE INCIDENT DUE TO THE DEVICE BREAKAGE (MALFUNCTION), AS ALTHOUGH IT DID NOT LEAD TO DEATH OR SERIOUS HEALTH DETERIORATION THIS MIGHT HAVE OCCURRED UNDER LESS FORTUNATE CIRCUMSTANCES. ACCORDING TO TECHNICAL ANALYSIS, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. NO FURTHER INFORMATION COULD BE OBTAINED.

    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 PHYSICIAN IN UNITED STATES ON 03-OCT-2014 WHICH REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT), LOT NUMBER B02266, IMPLANTED FOR PERMANENT STERILIZATION ON (B)(6)-2014. SHE WAS NOT PREGNANT. IT WAS REPORTED THAT THE PHYSICIAN WENT TO INSERT DEVICE AND HE WENT TO DEPLOY IT, A PORTION OF THE DEVICE BROKE OFF. BROKEN PIECE WAS REMOVED FROM UTERINE CAVITY. THE PHYSICIAN COULD SEE INNER COILS THERE, HE COULD SEE TIP OF COIL AND HE COULD SEE ALL EXCEPT A PORTION OF OUTER COIL. HE CHECKED CATHETER AND THERE WAS NO MICRO-INSERT STILL ATTACHED TO IT. HE SAID THAT ABOUT THREE COILS (THE BROKEN PIECE) WERE EXTRACTED FROM UTERINE CAVITY. PATIENT HAD SUCCESSFUL PLACEMENT ON ONE SIDE. PATIENT WAS COUNSELLED THAT WAS NOT NORMAL AND SHE WAS TOLD TO WAIT TO SEE RESULTS OF HSG TEST. NO TREATMENT WAS REQUIRED. THE PATIENT WAS OK. ESSURE WAS NOT REMOVED. UNIT WAS AVAILABLE FOR RETURN. THE PHYSICIAN HANDED BROKEN PIECE OF COIL IN A BIOHAZARDOUS BAG. NO FURTHER INFORMATION WAS PROVIDED. PTC INVESTIGATION RESULT WAS RECEIVED ON 22-OCT-2014. THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: (B)(4). FINAL ASSESSMENT: LOT B02266. PRODUCTION DATE: FEB-2013. EXPIRATION DATE 29-FEB-2016. WHEN A TERM LIKE "A PORTION OF THE DEVICE BROKE OFF..." IS USED WHEN DESCRIBING A DEVICE EVENT, IT IS DIFFICULT TO DETERMINE THE TRUE NATURE OF THE EVENT FROM THE COMPLAINT DESCRIPTION ALONE OR PRODUCT IS RETURNED FOR INVESTIGATION. 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 MICROINSERT 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 MICRO-INSERT, 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 MICRO-INSERT. AS OF 10/13/2014, 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, 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. 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. CONCLUSIONS: THE POSSIBILITY OF PIECES OF THE DELIVERY SYSTEM OR MICRO-INSERT BREAKING OFF DURING THE PROCEDURE IS AN ANTICIPATED EVENT. ACCORDING TO THE DFMEA, THE MAIN CONSEQUENCE IS A PHYSICIAN INCONVENIENCE BECAUSE THE PROCEDURE COULD NEED TO BE ABORTED OR RESCHEDULED. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A PRODUCT QUALITY ISSUE. IN ADDITION, THE AE CASE REFERS TO A USABILITY ISSUE. THE BATCH DOCUMENTATION OF THE REPORTED BATCH WAS REVIEWED. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER TECHNICAL INVESTIGATION. THE TECHNICAL ASSESSMENT CONCLUDED "UNCONFIRMED QUALITY DEFECT". AT THIS POINT IN TIME NO ADVERSE EVENTS HAVE BEEN REPORTED THEREFORE A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. THE REPORTED USABILITY ISSUE WILL BE SUBJECT TO POST MARKETING SURVEILLANCE MONITORING. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND IT WAS REPORTED THAT THE PHYSICIAN WENT TO DEPLOY IT, A PORTION OF THE DEVICE BROKE OFF. THIS EVENT, INTERPRETED AS DEVICE BREAKAGE, IS NON-SERIOUS AND LISTED FOR ESSURE ACCORDING TO TECHNICAL ANALYSIS. DURING DIFFICULT INSERTION/REMOVALS, SINGLE CASES HAVE BEEN REPORTED OF ESSURE BREAKAGE. IN THIS PARTICULAR CASE, THE DEVICE BREAKAGE OCCURRED DURING ESSURE INSERTION. PHYSICIAN STATED THAT THREE COILS (THE BROKEN PIECE) WERE EXTRACTED FROM UTERINE CAVITY AND PATIENT HAD SUCCESSFUL PLACEMENT ON ONE SIDE. THEREFORE, A CAUSAL RELATIONSHIP BETWEEN THE REPORTED EVENT AND ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS OTHER REPORTABLE INCIDENT DUE TO THE DEVICE BREAKAGE (MALFUNCTION), AS ALTHOUGH IT DID NOT LEAD TO DEATH OR SERIOUS HEALTH DETERIORATION THIS MIGHT HAVE OCCURRED UNDER LESS FORTUNATE CIRCUMSTANCES. ACCORDING TO TECHNICAL ANALYSIS, 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
    692323 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 B02266

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR