BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 4111201 · Received September 23, 2014

    Report

    Report Number
    2951250-2014-00397
    Event Type
    Malfunction
    Date Received
    September 23, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PTC INVESTIGATION RESULT RECEIVED ON 02-MAR-2015. PTC GLOBAL NUMBER (B)(4). BATCH C06497 WAS IDENTIFIED AS INVALID BATCH NUMBER. FINAL ASSESSMENT: DETACHMENT DIFFICULTY IS DEFINED AS A FAILURE OF THE MICRO-INSERT TO DETACH (SEPARATE) FROM THE DELIVERY SYSTEM. PER THE INSTRUCTIONS FOR USE (IFU), THE PHYSICIAN MUST PERFORM THE FOLLOWING STEPS IN ORDER TO ACHIEVE PROPER DETACHMENT: ROLLBACK TO INITIAL HARD STOP. DEPRESS BUTTON. PERFORM FINAL ROLLBACK. UNDER NORMAL CIRCUMSTANCES, WHEN THE PHYSICIAN COMPLETES ALL DEPLOYMENT STEPS AS OUTLINED IN THE IFU, THE MICRO-INSERT ASSEMBLY WILL DETACH FROM THE DELIVERY WIRE AND REMAIN IN THE FALLOPIAN TUBE. 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, THE OUTER CATHETER, THE INNER CATHETER, AND ALL PARTS WITHIN THE HANDLE ASSEMBLY. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE WERE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. THE POSSIBILITY OF A DEPLOYMENT DIFFICULTY EVENT DURING THE PROCEDURE IS AN ANTICIPATED EVENT. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A PRODUCT ISSUE AND USABILITY ISSUE. IN THE CURRENT CASE, COMPLICATED INSERTION WAS REPORTED TOGETHER WITH USE ERROR AND OFF LABEL USE. THE CASE REFERS ALSO TO TECHNICAL COMPLAINTS (SCOPE WOULD NOT ROLL BACK, DEVICE GOT CAUGHT IN THE OSTIA AND UNRAVELED) AND A USABILITY ISSUE. HOWEVER, NO ADVERSE EVENTS HAVE BEEN REPORTED AT THIS POINT IN TIME. NO FURTHER TECHNICAL INVESTIGATION WAS POSSIBLE SINCE ACCORDING TO THE RQU THE REPORTED BATCH NUMBER WAS IDENTIFIED AS INVALID BATCH NUMBER. THE REPORTED TECHNICAL COMPLAINTS COULD NOT BE EVALUATED IN MORE DETAIL DUE TO LACK OF SAMPLE RETURN. 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 NEITHER A QUALITY DEFECT WAS CONFIRMED NOR AN ADVERSE EVENT WAS REPORTED AT THIS POINT IN TIME. 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 SCOPE WOULD NOT ROLL BACK AND THE REP ADVISED THE HCP TO PULL OUT, THE DEVICE GOT CAUGHT IN THE OSTIA AND UNRAVELED, THEN MAJORITY OF THE DEVICE WAS ABLE TO BE CUT OUT, BUT A FEW COILS REMAINED IN THE PATIENT. THE REPORTED EVENTS, INTERPRETED AS DEVICE DEPLOYMENT ISSUE, SHAPE ALTERATION AND DEVICE MISUSE (PHYSICIAN CUT THE INSERT) WERE CONSIDERED NON-SERIOUS; THE POSSIBILITY OF A DEPLOYMENT DIFFICULTY EVENT DURING THE PROCEDURE WAS REGARDED AS ANTICIPATED (LISTED) EVENT ACCORDING TO PRODUCT TECHNICAL ANALYSIS (PTC). IN THIS PARTICULAR CASE, CONSIDERING THE REPORTED EVENTS OCCURRED IN ASSOCIATION WITH ESSURE PLACEMENT PROCEDURE, A CAUSAL RELATIONSHIP WITH SUSPECT INSERT CANNOT BE EXCLUDED (WITH EXCEPTION OF THE REPORTED MISUSE, WHICH DUE TO ITS NATURE WAS CONSIDERED AS UNRELATED TO ESSURE). ADDITIONALLY IT WAS REPORTED THAT PHYSICIAN PERFORMED A HYDROTHERMAL ABLATION POST PROCEDURE. THIS CASE WAS REGARDED AS AN OTHER REPORTABLE INCIDENT AS ALTHOUGH THESE EVENTS DID NOT LEAD TO DEATH OR SERIOUS HEALTH DETERIORATION THIS MIGHT HAVE OCCURRED UNDER LESS FORTUNATE CIRCUMSTANCES. THE PERFORMED PTC ANALYSIS CONCLUDED THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT AS NEITHER A QUALITY DEFECT WAS CONFIRMED NOR AN ADVERSE EVENT WAS REPORTED AT THIS POINT IN TIME. NO FURTHER INFORMATION IS EXPECTED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A PHYSICIAN IN UNITED STATES ON (B)(6) 2014 WHICH REFERS TO A FEMALE PATIENT ((B)(6)-YEAR-OLD) WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2014 FOR PERMANENT BIRTH CONTROL, WITH LOT NUMBER C06497. THE PHYSICIAN DESCRIBED THAT THE SCOPE WOULD NOT ROLL BACK. THE SALES REPRESENTATIVE ADVISED THE PHYSICIAN TO PULL IT OUT, AND THE DEVICE GOT CAUGHT IN THE OSTIA AND UNRAVELED. THE MAJORITY OF THE DEVICE WAS ABLE TO BE CUT OUT, BUT A FEW COILS REMAINED IN THE PATIENT. THE PHYSICIAN PERFORMED A HYDROTHERMAL ABLATION POST PROCEDURE. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A (B)(6) YEARS-OLD FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND DURING THE PROCEDURE SCOPE WOULD NOT ROLL BACK AND THE REP ADVISED THE HCP TO PULL OUT, THE DEVICE GOT CAUGHT IN THE OSTIA AND UNRAVELED (COMPLICATION OF DEVICE INSERTION), THEN MAJORITY OF THE DEVICE WAS ABLE TO BE CUT OUT, BUT A FEW COILS REMAINED IN THE PATIENT. THE REPORTED EVENTS INTERPRETED AS DEVICE DEPLOYMENT ISSUE, SHAPE ALTERATION AND DEVICE MISUSE (PHYSICIAN CUT THE INSERT) WERE CONSIDERED NON-SERIOUS AND ARE LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE, EXCEPT FOR DEVICE GOT CAUGHT IN THE OSTIA AND UNRAVELED WHICH IS UNLISTED. THIS CASE WAS REGARDED AS AN OTHER REPORTABLE INCIDENT AS ALTHOUGH THESE EVENTS DID NOT LEAD TO DEATH OR SERIOUS HEALTH DETERIORATION THIS MIGHT HAVE OCCURRED UNDER LESS FORTUNATE CIRCUMSTANCES. IN THIS PARTICULAR CASE, A PRODUCT TECHNICAL ANALYSIS WILL BE REQUESTED FOR FURTHER EVALUATION OF THE EVENTS, HOWEVER, CONSIDERING THAT THEY OCCURRED IN ASSOCIATION WITH ESSURE PLACEMENT PROCEDURE, A CAUSAL RELATIONSHIP WITH SUSPECT INSERT CANNOT BE EXCLUDED (WITH EXCEPTION OF THE REPORTED MISUSE, WHICH DUE TO ITS NATURE WAS CONSIDERED AS UNRELATED TO ESSURE). ADDITIONALLY IT WAS REPORTED THAT PHYSICIAN PERFORMED A HYDROTHERMAL ABLATION POST PROCEDURE. FURTHER INFORMATION IS BEING SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590048 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 C06497

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR