BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 4113798 · Received September 24, 2014

    Report

    Report Number
    2951250-2014-00399
    Event Type
    Malfunction
    Date Received
    September 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
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    PTC INVESTIGATION RESULT WAS RECEIVED ON 24-SEP-2014. THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). (B)(4). FINAL ASSESSMENT: WHEN A TERM LIKE "BREAK", "BREAKAGE", "BROKE", "BROKEN", "FALLING APART", "FRACTURED", OR "SPLIT" 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 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. 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. MEDICAL ASSESSMENT: IN THE CURRENT CASE A TECHNICAL DEFECT (IMPLANT BROKE) IN THE CONTEXT OF A REPORTED COMPLICATED INSERTION WAS REPORTED. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED AT THIS POINT IN TIME. 3 FURTHER AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO BATCH NO. C13145 (PRODUCTION DATE 21-JAN-2014 AND EXPIRATION DATE 31-JAN-2017). THE REPORTED TECHNICAL DEFECT COULD NOT BE EVALUATED IN MORE DETAIL DUE TO LACK OF SAMPLE RETURN. ACCORDING TO THE TECHNICAL ASSESSMENT THE POSSIBILITY OF PIECES OF THE DELIVERY SYSTEM OR MICROINSERT BREAKING OFF DURING THE PROCEDURE IS AN ANTICIPATED EVENT. THE REVIEW OF THE MANUFACTURING AND RELEASE DOCUMENTATION OF THE CONCERNED BATCH GAVE NO REASON TO SUSPECT A QUALITY DEFECT. 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. FOLLOW UP INFORMATION RECEIVED FROM THE PHARMACIST ON 29-SEP-2014: THE PATIENT MEDICAL HISTORY INCLUDES GRAVIDA:2 PARA:2. ONE NORMAL FULL-TERM DELIVERY AND ONE CAESAREAN. DURING PROCEDURE, THE 2 OSTIA WERE SEEN. ESSURE WAS PLACED IN RIGHT FALLOPIAN TUBE WITHOUT ANY DIFFICULTY WITH 5 OUTER TRAILING COILS. ESSURE WAS PLACED IN LEFT FALLOPIAN TUBE. DELIVERY CATHETER BROKE UP DURING DEVICE RELEASE. DEVICE WAS REMOVED AND A NEW ESSURE WAS PLACED WITHOUT ANY DIFFICULTY WITH 6 OUTER TRAILING COILS. PROCEDURE WITHOUT INCIDENT. NO FURTHER INFORMATION WILL BE PROVIDED. THE LIST OF SIMILAR CASES CONTAINS REPORTS WITH SIMILAR EVENTS CODED IN (B)(4). IT INCLUDES RECENT CASES RECEIVED BY (B)(4) AND OLDER CASES RECEIVED FROM THE PREVIOUS OWNER OF THE ESSURE PRODUCT (CONCEPTUS). THESE LEGACY REPORTS HAVE BEEN RE-CODED ACCORDING TO (B)(4) STANDARDS. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON (B)(4) 2014 FOR THE FOLLOWING (B)(4) 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 SPONTANEOUS CASE REPORT REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND THE IMPLANT BROKE UP AT DELIVERY CATHETER WITHDRAWAL. THIS EVENT WAS CONSIDERED NON-SERIOUS AND UPON RECEIPT OF PRODUCT TECHNICAL ANALYSIS REGARDED AS LISTED (ANTICIPATED). DURING DIFFICULT INSERTION/REMOVALS, SINGLE CASES HAVE BEEN REPORTED OF ESSURE BREAKAGE. IN THE PRESENT CASE, IT WAS REPORTED THAT THE IMPLANT BROKE UP AT DELIVERY CATHETER WITHDRAWAL. DEVICE WAS REMOVED AND A NEW ESSURE WAS PLACED. BASED ON THE AVAILABLE INFORMATION AND THE NATURE OF THE REPORTED EVENT, IT WAS CONSIDERED RELATED TO ESSURE. THIS CASE WAS REGARDED AS OTHER REPORTABLE INCIDENT DUE TO THE DEVICE BREAKAGE. ACCORDING TO THE TECHNICAL ASSESSMENT THE POSSIBILITY OF PIECES OF THE DELIVERY SYSTEM OR MICROINSERT BREAKING OFF DURING THE PROCEDURE IS AN ANTICIPATED EVENT. 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. NO FURTHER INFORMATION IS EXPECTED.

    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 PHARMACIST IN (B)(6) ON (B)(6) 2014 WHICH REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2014. ESSURE LOT NUMBER C13145. PHARMACIST REPORTED THAT THE IMPLANT BROKE UP AT DELIVERY CATHETER WITHDRAWAL (COMPLICATION OF DEVICE INSERTION). CLINICAL CONSEQUENCES OF THE EVENT WERE THAT A NEW IMPLANT WAS USED AND PROCEDURE WAS PROLONGED. MEDICAL DEVICE WAS NOT KEPT. NO FURTHER INFORMATION WAS PROVIDED. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REPORT REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND THE IMPLANT BROKE UP AT DELIVERY CATHETER WITHDRAWAL. THIS EVENT WAS CONSIDERED NON-SERIOUS AND IT IS UNLISTED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. DURING DIFFICULT INSERTION/REMOVALS, SINGLE CASES HAVE BEEN REPORTED OF ESSURE BREAKAGE. IN THE PRESENT CASE, IT WAS REPORTED THAT THE IMPLANT BROKE UP AT DELIVERY CATHETER WITHDRAWAL. NO FURTHER DETAILS WERE PROVIDED. BASED ON THE AVAILABLE INFORMATION AND THE NATURE OF THE REPORTED EVENT, IT WAS CONSIDERED RELATED TO ESSURE. THIS CASE WAS REGARDED AS OTHER REPORTABLE INCIDENT DUE TO THE DEVICE BREAKAGE. ADDITIONAL INFORMATION FROM REPORTED AND PRODUCT TECHNICAL ANALYSIS HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594872 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 C13145

    Patients

    Seq Age Sex Outcome Treatment
    1