BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 3993945 · Received July 24, 2014

    Report

    Report Number
    2951250-2014-00304
    Event Type
    Malfunction
    Date Received
    July 24, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY CAUSALITY COMMENT: THIS MEDICAL CONFIRMED REPORT REFERS TO A FEMALE PT OF UNSPECIFIED AGE WHO HAD AN ATTEMPT OF ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTION AND EXPERIENCED BRAKE OF THE COIL, THREAD NOT RELEASED, FAILED INSERTION AND COMPLICATION OF DEVICE REMOVAL. ALL THE EVENTS ARE CONSIDERED NON-SERIOUS AND LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. THE EVENT THE COIL THAT WOULD HAVE UNCOILED AT DISTAL EXTREMITY BROKE IN TWO (ASSUMED AS DEVICE BREAKAGE) WAS REGARDED AS NEAR-INCIDENT DUE TO THE REPORTED BREAKAGE. DURING DIFFICULT INSERTION, SINGLE CASES HAVE BEEN REPORTED OF ESSURE BREAKAGE. IN THIS PARTICULAR CASE, IT WAS MENTIONED THAT THE PRACTITIONER MET A PROBLEM AT THE TIME OF THE RELEASE AND THE REMOVAL OF ESSURE (FALLOPIAN TUBE OCCLUSION INSERT): BREAK OF THE COIL, THREAD NOT RELEASED AND SYSTEM REMOVED WITH BIOPSY PLIERS. USE OF THE A SECOND ESSURE SYSTEM. BASED ON THE AVAILABLE INFORMATION AND DUE TO LACK OF ALTERNATIVE EXPLANATION, CAUSALITY BETWEEN THE EVENTS ABOVE AND ESSURE USE WAS CONSIDERED AS RELATED.

    Additional Manufacturer Narrative · 1

    DATA CORRECTION: THE PRODUCT CODE KNH WAS REPLACED WITH HHS.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP RECEIVED ON 30-JAN-2015. PRODUCT TECHNICAL COMPLAINT INVESTIGATION AND FINAL ASSESSMENT WERE UPDATED: THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS (B)(4). FINAL ASSESSMENT: LOT NUMBER: C26940; EXPIRATION DATE: 28-FEB-2017; PRODUCTION DATE: 20-FEB-2014. SINCE PRODUCT WAS RETURNED TO US FOR THIS COMPLAINT, WE WERE ABLE TO CONDUCT AN INVESTIGATION OF THE RETURNED PRODUCT. WE TYPICALLY INSPECT THE MICRO-INSERT, OUTER CATHETER, THE INNER CATHETER, AND ALL PARTS WITHIN THE HANDLE ASSEMBLY. AS RECEIVED, MICRO-INSERT FOUND TO BE STRETCHED AND BROKEN IN PIECES. ALL IFU STEPS WERE COMPLETED. WE WERE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. WE ALSO 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. THE POSSIBILITY OF MICRO-INSERT BREAKING DURING THE PROCEDURE IS AN ANTICIPATED EVENT. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A REPORTED PRODUCT QUALITY ISSUE (BREAKAGE). IN THIS PARTICULAR CASE, BREAKAGE WAS REPORTED IN THE CONTEXT OF USABILITY ISSUES. AT THIS POINT IN TIME THE AE CASE REFERS NO FURTHER ADVERSE EVENTS. THE BATCH DOCUMENTATION OF THE REPORTED BATCH WAS REVIEWED. THE PROVIDED COMPLAINT SAMPLE WAS FOUND STRETCHED AND BROKEN IN PIECES, HOWEVER THE INVESTIGATION COULD NOT CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. SINCE NO ADVERSE EVENTS HAVE BEEN REPORTED, 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 AS NO QUALITY DEFECT WAS CONFIRMED NEITHER AN ADVERSE EVENT WAS REPORTED AT THIS POINT IN TIME. THE LIST OF SIMILAR CASES CONTAINS REPORTS WITH SIMILAR EVENTS CODED IN MEDDRA. IT INCLUDES RECENT CASES RECEIVED BY BAYER PHARMA AND OLDER CASES RECEIVED FROM THE PREVIOUS OWNER OF THE ESSURE PRODUCT (CONCEPTUS). THESE LEGACY REPORTS HAVE BEEN RE-CODED ACCORDING TO BAYER PHARMA STANDARDS. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 02-FEB-2015 FOR THE FOLLOWING MEDDRA PREFERRED TERM: DEVICE BREAKAGE. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED (B)(4) CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. THIS INCLUDES CONSIDERATION OF THE LEGACY CASES IN SAFETY ANALYSES. THE CUMULATIVE REVIEW OF THE REPORTS HAS NOT YIELDED ANY NEW SAFETY SIGNAL. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED REPORT REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE WHO HAD AN ATTEMPT OF ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTION AND EXPERIENCED BREAK OF THE COIL AND THREAD NOT RELEASED. BOTH EVENTS ARE NON-SERIOUS AND LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. DURING DIFFICULT INSERTION, SINGLE CASES HAVE BEEN REPORTED OF ESSURE BREAKAGE. IN THIS PARTICULAR CASE, IT WAS MENTIONED THAT THE PRACTITIONER MET A PROBLEM AT THE TIME OF THE RELEASE AND THE REMOVAL OF ESSURE (FALLOPIAN TUBE OCCLUSION INSERT): BREAK OF THE COIL, THREAD NOT RELEASED AND SYSTEM REMOVED WITH BIOPSY PLIERS. USE OF A SECOND ESSURE SYSTEM. BASED ON THE AVAILABLE INFORMATION AND DUE TO LACK OF ALTERNATIVE EXPLANATION, CAUSALITY BETWEEN THE EVENTS ABOVE AND ESSURE USE WAS CONSIDERED AS RELATED. THIS CASE WAS REGARDED AS OTHER REPORTABLE INCIDENT DUE TO THE DEVICE BREAKAGE, AS ALTHOUGH IT DID NOT LEAD TO DEATH OR SERIOUS HEALTH DETERIORATION THIS MIGHT HAVE OCCURRED UNDER LESS FORTUNATE CIRCUMSTANCES ACCORDING TO PRODUCT TECHNICAL COMPLAINT INVESTIGATION RESULTS, THE REVIEW OF 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" AND NOTED THAT THE BREAKAGE IS AN ANTICIPATED EVENT. BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT AS NO QUALITY DEFECT WAS CONFIRMED NEITHER AN ADVERSE EVENT WAS REPORTED AT THIS POINT IN TIME.

    Additional Manufacturer Narrative · 1

    PTC INVESTIGATION RESULT WAS RECEIVED ON 23-JUL-2014. THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: PTC GLOBAL NUMBER (B)(4). FINAL ASSESSMENT: WHEN A TERM LIKE "BREAK" IS 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, IF THE MICRO-INSERT BENT OR STRETCHED INTO AN UNINTENDED SHAPE, AND HENCE WAS CONSIDERED BY THE REPORTER TO BE "BROKEN", OR IF A DIFFERENT PORTION OF THE DELIVERY CATHETER WAS BROKEN OFF INSIDE THE PATIENT. 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 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. 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. CONCLUSIONS: THE REPORT DID NOT STATE A PATIENT INJURY OCCURRED. 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 CASE REPORTED COMPLICATION OF INSERTION AND DIFFICULT TO USE DUE TO DEPLOYMENT ISSUE AS WELL AS BREAKAGE BUT THESE REPORTED EVENTS ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. NO ADDITIONAL AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO BATCH NUMBER C26940. NO BATCH SIGNAL CAN BE IDENTIFIED AT THIS TIME. THE REVIEW OF 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" AND NOTED THAT THE BREAKAGE IS AN ANTICIPATED EVENT. BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED REPORT REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE WHO HAD AN ATTEMPT OF ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTION AND EXPERIENCED BREAK OF THE COIL, THREAD NOT RELEASED, FAILED INSERTION AND COMPLICATION OF DEVICE REMOVAL. ALL THE EVENTS ARE CONSIDERED NON-SERIOUS AND LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. THE EVENT THE COIL THAT WOULD HAVE UNCOILED AT DISTAL EXTREMITY BROKE IN TWO (ASSUMED AS DEVICE BREAKAGE) WAS REGARDED AS NEAR-INCIDENT DUE TO THE REPORTED BREAKAGE. DURING DIFFICULT INSERTION, SINGLE CASES HAVE BEEN REPORTED OF ESSURE BREAKAGE. IN THIS PARTICULAR CASE, IT WAS MENTIONED THAT THE PRACTITIONER MET A PROBLEM AT THE TIME OF THE RELEASE AND THE REMOVAL OF ESSURE (FALLOPIAN TUBE OCCLUSION INSERT): BREAK OF THE COIL, THREAD NOT RELEASED AND SYSTEM REMOVED WITH BIOPSY PLIERS. USE OF A SECOND ESSURE SYSTEM. BASED ON THE AVAILABLE INFORMATION AND DUE TO LACK OF ALTERNATIVE EXPLANATION , CAUSALITY BETWEEN THE EVENTS ABOVE AND ESSURE USE WAS CONSIDERED AS RELATED. ACCORDING TO PRODUCT TECHNICAL COMPLAINT INVESTIGATION RESULTS, THE REVIEW OF 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" AND NOTED THAT THE BREAKAGE IS AN ANTICIPATED EVENT. BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A OTHER HEALTH PROFESSIONAL IN (B)(6) ON (B)(6) 2014, WHICH REFERS TO A FEMALE PT OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTION ATTEMPTED AND EXPERIENCED BREAK OF THE COIL, THREAD NOT RELEASED, COMPLICATION OF DEVICE INSERTION, AND FAILED INSERTION. ON (B)(6) 2014, THE PRACTITIONER MET A PROBLEM AT THE TIME OF THE RELEASE AND THE REMOVAL OF ESSURE (FALLOPIAN TUBE OCCLUSION INSERT): BREAK OF THE COIL, THREAD NOT RELEASED AND SYSTEM REMOVED WITH BIOPSY PLIERS. USE OF A SECOND ESSURE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435163 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 C26940

    Patients

    Seq Age Sex Outcome Treatment
    1