BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 3993973 · Received July 24, 2014

    Report

    Report Number
    2951250-2014-00297
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    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
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP INFORMATION RECEIVED ON 22-AUG-2014. THE PATIENT´S DATE OF BIRTH WAS ADDED; SHE WAS (B)(6). ESSURE WAS INSERTED ON (B)(6) 2014. IT WAS REPORTED THAT ALL COILS FELL OUT. THE WHOLE DEVICE WAS FALLEN OUT ON (B)(6) AND HANDED OUT TO THE POLICLINIC AND THAT IS CONFIRMED WITH A DIAGNOSTIC HYSTEROSCOPY ON (B)(6) 2014. AT THE SAME DAY, AN ATTEMPT TO REINSERT ESSURE OCCURRED, BUT THE INSERTION WAS NOT SUCCEED DUE TO A RESISTANCE DURING INSERTION AT THE TUBE ON A BIT OF DISTANCE. NO FURTHER INFORMATION WAS PROVIDED. 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 DURING THE PROCEDURE ESSURE DID NOT UNBLOCKED AND STRETCHED OUT, BROKE OFF AND A COUPLE COILS REMAINED BEHIND, FELL OFF THE PATIENT THEMSELVES. LATER DURING AN ATTEMPT TO REINSERT ESSURE THERE WAS RESISTANCE AT THE TUBE DURING INSERTION, COMPLICATION OF DEVICE INSERTION AND ESSURE PLACEMENT DID NOT SUCCEED. REPORTER CAUSALITY WAS NOT PROVIDED. ALL THE REPORTED EVENTS ARE NON-SERIOUS, LISTED ON THE REFERENCE SAFETY INFORMATION FOR ESSURE AND WERE CONSIDERED NON-INCIDENTS, WITH EXCEPTION OF THE REPORTED BREAKAGE WHICH IS UNLISTED AND WAS CONSIDERED OTHER REPORTABLE INCIDENT, AS ALTHOUGH IT DID NOT LEAD TO DEATH OR SERIOUS HEALTH DETERIORATION THIS MIGHT HAVE OCCURRED UNDER LESS FORTUNATE CIRCUMSTANCES. SINGLE CASES OF ESSURE BREAKAGE HAVE BEEN REPORTED. IN THIS PARTICULAR CASE, THE PHYSICIAN HAD DIFFICULTIES DURING THE INSERT DEPLOYMENT (IT DID NOT UNBLOCKED), ESSURE STRETCHED OUT AND BROKE OFF; AND THE COILS THAT REMAINED FELL OFF THE PATIENT. AN ATTEMPT TO REINSERT ESSURE FAILED. CONSIDERING THAT THE REPORTED EVENTS OCCURRED IN ASSOCIATION WITH ESSURE PLACEMENT PROCEDURE, THEIR CAUSAL RELATIONSHIP WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. A PRODUCT TECHNICAL COMPLAINT ANALYSIS WAS PREVIOUSLY PERFORMED (DUE TO INITIAL COMPLAINT OF PROBLEMS WITH INSERT AND INTRODUCER) AND WAS UNABLE TO CONFIRM THE COMPLAINT, FURTHER PTC ANALYSIS (TO ASSESS THE REPORTED EVENTS) IS BEING SOUGHT.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PRODUCT TECHNICAL COMPLAINT INVESTIGATION AND FINAL ASSESSMENT WERE RECEIVED ON (B)(4) 2014: THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: (B)(4). FINAL ASSESSMENT: 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 PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE ABLE TO CONDUCT AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. WE WERE ABLE TO INSPECT THE MICRO-INSERT, OUTER CATHETER, THE INNER CATHETER, AND ALL PARTS WITHIN THE HANDLE ASSEMBLY TO CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR. WE WERE UNABLE TO IDENTIFY ANY MANUFACTURING DEFICIENCIES. AS RECEIVED, THE LARGE TIGHT PITCH COIL WAS STRETCHED AND BROKEN. ALL IFU STEPS WERE COMPLETED AS EVIDENCED BY THE LOCATION OF THE DELIVERY WIRE HOLDER WITHIN THE HANDLE ASSEMBLY. 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. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION 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 ANTICIPATE EVENT. ACCORDING TO THE DFMEA, THE MAIN CONSEQUENCE IS A PHYSICIAN INCONVENIENCE BECAUSE THE PROCEDURE COULD NEED TO BE ABORTED OR RESCHEDULED. MEDICAL ASSESSMENT: THE REPORTED ADVERSE EVENTS IS NOT INDICATIVE OF A QUALITY DEFICIT PER SE. IN THIS PARTICULAR CASE, TECHNICAL DEFECTS (ESSURE BROKE OFF, DID NOT UNBLOCK) WERE REPORTED. IN ADDITION, A DEVICE USE ERROR WAS REPORTED. THE INVESTIGATION OF THE RETURNED COMPLAINT SAMPLE FOUND THE LARGE TIGHT PITCH COIL WAS STRETCHED AND BROKEN. HOWEVER, NO MANUFACTURING DEFICIENCIES COULD BE IDENTIFIED DURING THE COMPLAINT SAMPLE INSPECTION (SEE TECHNICAL STATEMENT). THE TECHNICAL ASSESSMENT CONCLUDED AN "UNCONFIRMED QUALITY DEFECT". 2 FURTHER AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO BATCH NO. B06097 (PRODUCTION DATE FEB-2013 AND EXPIRATION DATE 29-FEB-2016), NONE OF THEM REFERRING TO A SIMILAR ADVERSE TYPE OF EVENTS. NO BATCH SIGNAL COULD BE IDENTIFIED. IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT. 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 (B)(4) 2014 FOR THE FOLLOWING MEDDRA PREFERRED TERM: DEVICE BREAKAGE. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 853 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, SPONTANEOUS CASE REPORT REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND DURING THE PROCEDURE IT BROKE OFF AND A COUPLE COILS REMAINED BEHIND. THIS EVENT, INTERPRETED AS DEVICE BREAKAGE, WAS CONSIDERED NON-SERIOUS AND PREVIOUSLY REGARDED AS UNLISTED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE; HOWEVER UPON RECEIPT OF THE PRODUCT TECHNICAL ANALYSIS (PTC), WHICH STATED THAT MICRO-INSERT BREAKING OFF DURING THE PROCEDURE IS AN ANTICIPATED EVENT; IT WAS AMENDED TO LISTED. DURING DIFFICULT INSERTION/REMOVALS, SINGLE CASES HAVE BEEN REPORTED OF ESSURE BREAKAGE. IN THIS PARTICULAR CASE, THE PHYSICIAN HAD DIFFICULTIES DURING THE INSERT DEPLOYMENT (IT DID NOT UNBLOCK), ESSURE STRETCHED OUT AND BROKE OFF; AND THE COILS THAT REMAINED FELL OFF THE PATIENT. LATER DURING AN ATTEMPT TO REINSERT ESSURE THERE WAS RESISTANCE AT THE TUBE DURING INSERTION, COMPLICATION OF DEVICE INSERTION AND ESSURE PLACEMENT DID NOT SUCCEED. CONSIDERING THAT THE REPORTED EVENT OCCURRED IN ASSOCIATION WITH ESSURE PLACEMENT PROCEDURE, A CAUSAL RELATIONSHIP WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS OTHER REPORTABLE INCIDENT DUE TO THE REPORTED DEVICE BREAKAGE, AS ALTHOUGH IT DID NOT LEAD TO DEATH OR SERIOUS HEALTH DETERIORATION THIS MIGHT HAVE OCCURRED UNDER LESS FORTUNATE CIRCUMSTANCES. PRODUCT TECHNICAL COMPLAINT (PTC) ANALYSIS CONCLUDED TO AN UNCONFIRMED QUALITY DEFECT. MEDICAL PTC ASSESSMENT CONSIDERED THAT, BASED ON THE AVAILABLE INFORMATION, THERE IS NO REASON TO SUSPECT QUALITY DEFECT OF THE PRODUCT. NO FURTHER INFORMATION IS EXPECTED.

    Description of Event or Problem · 1

    THIS IS A SOLICITED CASE REPORT RECEIVED FROM A GYNECOLOGIST/OBSTETRICIAN IN (B)(6) ON (B)(6) 2014, WHICH REFERS TO A FEMALE PATIENT OF AN UNSPECIFIED AGE, WHO WAS INVOLVED IN A REIMBURSEMENT OR COMPENSATION ACTIVITY, STUDY NUMBER: (B)(4), HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED THE ADVERSE EVENTS AS DESCRIBED BELOW. ON (B)(6) 2014, IT WAS ALSO PROVIDED WITH THE INITIAL REPORT THE PRODUCT TECHNICAL COMPLAINT (PTC) INVESTIGATION RESULTS PERFORMED ON (B)(6) 2014 (INITIAL COMPLAINT WAS A PTC ONLY) REGARDING THE ESSURE LOT NUMBER B06097 AND A SAMPLE OF THE ESSURE INVOLVED IN THIS COMPLAINT. STUDY DESCRIPTION: ESSURE GENERIC REIMBURSEMENT PROGRAM. ESSURE LOT NUMBER USED B06097. THIS GYNECOLOGIST ASKED FOR A REPLACING ESSURE BECAUSE THE ESSURE DID NOT UNBLOCK. GYNECOLOGIST EXPLAINED THAT HE THOUGHT THE ESSURE LET GO WHEN PRESSING THE BUTTON, BUT THIS WAS NOT THE CASE WHEN IT STRETCHED OUT AND BROKE OFF. A COUPLE COILS REMAINED BEHIND, BUT ACCORDING TO THE GYNECOLOGIST, THESE FELL OFF THE PATIENT ON ITS OWN. GYNECOLOGIST WAS NOT SURE, BUT ACCORDING TO HIM, REPLACEMENT HAS ALREADY BEEN PERFORMED BY ANOTHER PHYSICIAN. PTC - TECHNICAL ASSESSMENT: JUSTIFICATION: UNCONFIRMED QUALITY DEFECT. FINAL ASSESSMENT: INSPECTION RESULTS: LARGE TIGHT PITCH COIL WAS STRETCHED AND BROKEN. ALL IFU STEPS WERE COMPLETED. LOT HISTORY RECORD (LHR) REVIEWED. PRODUCT MET PRODUCT RELEASE SPECIFICATIONS. FINAL RISK CLASSIFICATION: RISK CATEGORY IV. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT, REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND DURING THE PROCEDURE ESSURE DID NOT UNBLOCK AND STRETCHED OUT AND BROKE OFF AND A COUPLE REMAINED BEHIND AND FELL OFF THE PATIENT ON ITS OWN. REPORTER CAUSALITY WAS NOT PROVIDED. THE REPORTED EVENTS, INTERPRETED AS A DEPLOYMENT ISSUE, HANDLING ISSUE (STRETCHED), DEVICE BREAKAGE AND EXPULSION (COILS FELL OFF) ARE NON-SERIOUS, LISTED ON THE REFERENCE SAFE INFORMATION FOR ESSURE AND WERE CONSIDERED NON-INCIDENTS, WITH EXCEPTION OF THE REPORTED BREAKAGE WHICH IS UNLISTED AND WAS CONSIDERED A NEAR-INCIDENT, ALTHOUGH IT DID NOT LEAD TO DEATH OR SERIOUS HEALTH DETERIORATION, THIS MIGHT HAVE OCCURRED UNDER LESS FORTUNATE CIRCUMSTANCES. SINGLE CASE OF ESSURE BREAKAGE HAVE BEEN REPORTED. IN THIS PARTICULAR CASE, THE PHYSICIAN HAD DIFFICULTIES DURING THE INSERT DEPLOYMENT (IT DID NOT UNBLOCK), ESSURE STRETCHED OUT AND BROKE OFF; AND THE COILS THAT REMAINED, FELL OFF THE PATIENT. CONSIDERING THAT THESE EVENTS OCCURRED IN ASSOCIATION WITH ESSURE PLACEMENT PROCEDURE, THEIR CASAL RELATIONSHIP WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. FOLLOW-UP INFORMATION IS BEING SOUGHT. A PRODUCT TECHNICAL COMPLAINT ANALYSIS WAS PREVIOUSLY PERFORMED (DUE TO INITIAL COMPLAINT OF PROBLEMS WITH INSERT AND INTRODUCER) AND WAS UNABLE TO CONFIRM THE COMPLAINT, FURTHER PTC ANALYSIS (TO ASSESS THE REPORTED EVENTS) IS BEING SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434481 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 B06097

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR