BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5657654 · Received May 16, 2016

    Report

    Report Number
    2951250-2016-00609
    Event Type
    Injury
    Date Received
    May 16, 2016
    Report Date
    January 23, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP 27-MAY-2016: THE LOT NUMBER WAS UPDATED FROM D133378 TO D13378.T.

    Additional Manufacturer Narrative · 1

    FOLLOW UP 22-JUN-2016: QUALITY-SAFETY EVALUATION OF PTC (B)(4). LOT NUMBER: D13378. AS OF 20-JUN-2016, THE RQU HAS NOT RECEIVED RETURNED PRODUCT FOR THIS CASE. THIS CASE IS BEING PROCESSED AS IF NOPRODUCT WILL BE RETURNED. IF PRODUCT IS RECEIVED BY THE RQU IN THE FUTURE, A CHILD CASE WILL BE OPENED AND AN INVESTIGATION WILL BE COMPLETED ON THE RETURNED DEVICE. THE ESSURE INSERT IS MADE UP OF A FLEXIBLE OUTER COIL THAT IS DEPLOYED INTO THE FALLOPIAN TUBE. THE INSERTS 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 ALL IFU STEPS HAVE NOT BEEN COMPLETED, USER ATTEMPTS TO REPOSITION OR REMOVE THE CATHETER ASSEMBLY COULD LEAD TO EITHER A STRETCHING OR BREAKAGE OF THE MICRO-INSERT OR A PART OF THE CATHETER. 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. DEPLOYMENT DIFFICULTY IS DEFINED AS A FAILURE OF THE MICRO-INSERT OUTER COILS TO EXPAND FROM THE WOUND DOWN POSITION. PER THE INSTRUCTIONS FOR USE (IFU), THE PHYSICIAN MUST PERFORM THE FOLLOWING STEPS IN ORDER TO ACHIEVE PROPER DEPLOYMENT: ROLLBACK TO INITIAL HARD STOP. DEPRESS BUTTON. PERFORM FINAL ROLLBACK. UNDER NORMAL CIRCUMSTANCES, WHEN THE PHYSICIAN COMPLETES THE PROPER ESSURE PLACEMENT STEPS, THE RELEASE RIBBON SHOULD DISENGAGE FROM THE PLATINUM HALF BAND (WELDED ONTO OUTER COILS OF MICRO-INSERT). ONCE DISENGAGEMENT OCCURS, THE OUTER COILS SHOULD EXPAND. IF IT DOES NOT, THIS IS REFERRED TO DEPLOYMENT DIFFICULTY. SEVERAL FACTORS CAN CONTRIBUTE TO A DEPLOYMENT DIFFICULTY EVENT. THE MOST LIKELY ROOT CAUSES ARE TUBAL SPASMS WHICH CAN CLAMP DOWN ON THE DISTAL END OF THE CATHETER AND REVENT THE MICRO-INSERT FROM EXPANDING AND RELEASING FROM THE DELIVERY WIRE, STRETCHING OF MICRO-INSERT DURING PLACEMENT ATTEMPTS WHICH TIGHTENS THE INSERTS GRIP ON THE DELIVERY WIRE, REPOSITIONING OF THE CATHETER AFTER THE FIRST ROLLBACK AND BUTTON PRESS ARE COMPLETED WHICH CAN ALSO TIGHTEN THE INSERTS GRIP ON THE DELIVERY WIRE, AND POTENTIAL MANUFACTURING DEFICIENCIES. 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. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, IT IS POSSIBLE THE ESSURE DEVICE COULD HAVE BEEN DEFECTIVE PRIOR TO REMOVAL FROM THE PACKAGE. THE POSSIBILITY OF A DEPLOYMENT DIFFICULTY EVENT IS AN ANTICIPATED EVENT AND THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. BASED ON THE AVAILABLE INFORMATION A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. BASED ON THE PROVIDED INFORMATION THE DEFECT TYPE CORRESPONDS TO THE FOLLOWING MEDDRA LLT: DEVICE DEPLOYMENT ISSUE. SINCE NO MEDICAL EVENTS WERE REPORTED AT THIS POINT IN TIME, THE ASSESSMENT OF A RELATIONSHIP WITH A QUALITY DEFECT, AS WELL AS, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES ARE NOT APPLICABLE. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS MEDICALLY CONFIRMED CASE REPORT REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND DURING THE PROCEDURE THE MICRO-INSERT BROKE. THIS EVENT IS NON-SERIOUS AND UNLISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. HOWEVER ACCORDING TO PRODUCT INVESTIGATION IS ANTICIPATED. SINCE THE DEVICE BREAKAGE OCCURRED DURING INSERTION PROCEDURE, A CAUSAL RELATIONSHIP WITH ESSURE PROCEDURE CANNOT BE EXCLUDED. ADDITIONAL NON-SERIOUS EVENTS WERE ALSO REPORTED. THIS CASE WAS REGARDED AS OTHER REPORTABLE INCIDENT AS ALTHOUGH THE DEVICE BREAKAGE DID NOT LEAD TO DEATH OR SERIOUS DETERIORATION IN HEALTH, THIS MIGHT HAVE OCCURRED UNDER LESS FORTUNATE CIRCUMSTANCES. A PRODUCT TECHNICAL ANALYSIS CONCLUDED, BASED ON THE AVAILABLE INFORMATION A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE FURTHER INFORMATION IS EXPECTED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP FROM 01-AUG-2016: FOLLOWUP ATTEMPTS HAS BEEN COMPLETED, WITH NO RESPONSE TO DATE. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS MEDICALLY CONFIRMED CASE REPORT REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND DURING THE PROCEDURE THE MICRO-INSERT BROKE. THIS EVENT IS NON-SERIOUS AND UNLISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. HOWEVER ACCORDING TO PRODUCT INVESTIGATION IS ANTICIPATED. SINCE THE DEVICE BREAKAGE OCCURRED DURING INSERTION PROCEDURE, A CAUSAL RELATIONSHIP WITH ESSURE PROCEDURE CANNOT BE EXCLUDED. ADDITIONAL NON-SERIOUS EVENTS WERE ALSO REPORTED. THIS CASE WAS REGARDED AS OTHER REPORTABLE INCIDENT AS ALTHOUGH THE DEVICE BREAKAGE DID NOT LEAD TO DEATH OR SERIOUS DETERIORATION IN HEALTH, THIS MIGHT HAVE OCCURRED UNDER LESS FORTUNATE CIRCUMSTANCES. A PRODUCT TECHNICAL ANALYSIS CONCLUDED, BASED ON THE AVAILABLE INFORMATION A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE DESPITE FOLLOW UP ATTEMPTS, NO FURTHER INFORMATION WAS 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 MEDICAL DOCTOR IN UNITED STATES ON 18-APR-2016 WHICH REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON (B)(6) 2016, LOT NUMBER D133378, FOR PERMANENT STERILIZATION. IT WAS REPORTED THAT DURING PLACEMENT, THE MICRO-INSERT BROKE; INSERTS BENT COMPLETELY OVER NOT ALLOWING FOR DEPLOYMENT. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS MEDICALLY CONFIRMED CASE REPORT REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND DURING THE PROCEDURE THE MICRO-INSERT BROKE. THIS EVENT IS NON-SERIOUS AND UNLISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. SINCE THE DEVICE BREAKAGE OCCURRED DURING INSERTION PROCEDURE, A CAUSAL RELATIONSHIP WITH ESSURE PROCEDURE CANNOT BE EXCLUDED. ADDITIONAL NON-SERIOUS EVENTS WERE ALSO REPORTED. THIS CASE WAS REGARDED AS OTHER REPORTABLE INCIDENT AS ALTHOUGH THE DEVICE BREAKAGE DID NOT LEAD TO DEATH OR SERIOUS DETERIORATION IN HEALTH, THIS MIGHT HAVE OCCURRED UNDER LESS FORTUNATE CIRCUMSTANCES. A PRODUCT TECHNICAL ANALYSIS AND FURTHER INFORMATION ARE EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313052 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 D13378

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR