BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 6078432 · Received November 4, 2016

    Report

    Report Number
    2951250-2016-02339
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Report Date
    October 1, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A PHARMACIST AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("BROKEN ESSURE INSERT") AND COMPLICATION OF DEVICE INSERTION ("RELEASE PROBLEM AND ESSURE BROKEN") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. HE011F2) INSERTED. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DEPLOYMENT ISSUE "RELEASE PROBLEM". ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE AND COMPLICATION OF DEVICE INSERTION. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE AND COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR COMPLICATION OF DEVICE INSERTION AND DEVICE BREAKAGE WITH ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION PROCEDURE WAS PERFORMED WITH ANOTHER ESSURE DEVICE. HEALTH CARE PROFESSIONAL HAD NO ADDITIONAL INFORMATION ABOUT THE PATIENT. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-OCT-2018: QUALITY SAFETY EVALUATION OF PTC. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    QUALITY-SAFETY EVALUATION OF PTC: PTC GLOBAL NUMBER: (B)(4). 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. 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 MICRO-INSERT BREAKING AND DETACHMENT DIFFICULTY ARE AN ANTICIPATED EVENT AND THERE WERE NO EVENTS REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. BASED ON THE PROVIDED INFORMATION THE DEFECT TYPE CORRESPONDS TO THE FOLLOWING MEDDRA LLT: DEVICE BREAKAGE AND DEVICE DEPLOYMENT ISSUE. BASED ON THE AVAILABLE INFORMATION A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-DEC-2016: NO FURTHER INFORMATION WAS PROVIDED DESPITE FOLLOW UP ATTEMPTS. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) PLACED AND THERE WAS A RELEASE PROBLEM AND BROKEN ESSURE. DEVICE BREAKAGE IS AN ANTICIPATED EVENT IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. CONSIDERING THE NATURE OF THIS EVENT AND THE FACT THAT IT OCCURRED DURING THE INSERTION PROCEDURE, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. THIS CASE IS REGARDED AS OTHER REPORTABLE INCIDENT AS ALTHOUGH THE DEVICE BREAKAGE DID NOT LEAD TO DEATH OR SERIOUS DETERIORATION IN HEALTH, IT MIGHT HAVE LED TO SERIOUS DETERIORATION OF HEALTH UNDER LESS FORTUNATE CIRCUMSTANCES. PRODUCT TECHNICAL ANALYSIS CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS (COMPLAINT SAMPLE WAS NOT AVAILABLE). HOWEVER, BASED ON THE AVAILABLE INFORMATION A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. FURTHER INFORMATION COULD NOT BE OBTAINED, DESPITE FOLLOW-UP ATTEMPTS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A PHARMACIST IN (B)(6) ON 11-OCT-2016 WHICH REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT), LOT NUMBER HE011F2, PLACED ON UNSPECIFIED DATE. ACCORDING TO PHARMACIST, RELEASE PROBLEM AND BROKEN ESSURE INSERT OCCURRED. ESSURE INSERTION PROCEDURE WAS PERFORMED WITH ANOTHER ESSURE DEVICE. HEALTH CARE PROFESSIONAL HAD NO ADDITIONAL INFORMATION ABOUT THE PATIENT. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED SPONTANEOUS CASE REPORT REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) PLACED AND THERE WAS A RELEASE PROBLEM AND BROKEN ESSURE. DEVICE BREAKAGE IS AN ANTICIPATED EVENT IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. CONSIDERING THE NATURE OF THIS EVENT AND THE FACT THAT IT OCCURRED DURING THE INSERTION PROCEDURE, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. THIS CASE IS REGARDED AS OTHER REPORTABLE INCIDENT AS ALTHOUGH THE DEVICE BREAKAGE DID NOT LEAD TO DEATH OR SERIOUS DETERIORATION IN HEALTH, IT MIGHT HAVE LED TO SERIOUS DETERIORATION OF HEALTH UNDER LESS FORTUNATE CIRCUMSTANCES. A PRODUCT TECHNICAL COMPLAINT ANALYSIS IS BEING SOUGHT. FURTHER INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730884 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 HE011F2

    Patients

    Seq Age Sex Outcome Treatment
    1