BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4802498 · Received May 28, 2015

    Report

    Report Number
    2951250-2015-00349
    Event Type
    Injury
    Date Received
    May 28, 2015
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP INFORMATION RECEIVED ON 24-JUN-2015 NEW REPORTERS WERE ADDED. THE PATIENT´S INITIAL AND DATE OF BIRTH WERE UPDATED (SHE WAS (B)(6) AT TIME OF EVENT). HER WEIGHT WAS (B)(6) AND HEIGHT WAS (B)(6). ESSURE WAS INSERTED ON (B)(6) 2015 WITH LOT NUMBER C91761 (EXPIRATION DATE JUL-2017). SHE WAS NOT IN A POSTPARTUM STATE AT TIME OF PROCEDURE. INSERTION AND VISUALIZATION OF TUBAL OSTIUM WERE CONSIDERED EASY. FLUID LOSS WAS LESS THAN 1500CC AND PROCEDURE DID NOT TAKE MORE THAN 20 MINUTES. HSG WAS NOT PERFORMED. AFTER INSERTION, SHE USED NUVARING. ON (B)(6) 2015, PELVIC ULTRASOUND WAS DONE AND RIGHT INSERT WAS NOT VISUALIZED. NORMAL PLACEMENT ON LEFT SIDE WAS REPORTED. ON (B)(6) 2015, ESSURE WAS REMOVED HYSTEROSCOPICALLY. DURING SURGERY, DEVICE WAS FOUND IN ENDOMETRIAL CAVITY. IT WAS REPORTED A PAIN FROM DEVICE EXPULSION CAUSED BY ESSURE. FOLLOW UP 01-JUL-2015: PTC INVESTIGATION RESULTS WERE UPDATED WITH THE LOT NUMBER C91761 AND WERE PROVIDED. PTC GLOBAL NUMBER: (B)(4). FINAL ASSESSMENT: 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 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. NO NEW FAILURE MODE HAS BEEN IDENTIFIED. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A REQUEST FOR CONFIRMATION OF QUALITY. THE REPORTED ADVERSE EVENT IS A KNOWN, POSSIBLE, UNDESIRABLE EVENT AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO SIMILAR AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO THE REPORTED BATCH. NO BATCH SIGNAL COULD BE IDENTIFIED. THE BATCH DOCUMENTATION OF THE REPORTED BATCH WAS REVIEWED. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. 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. 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 THE DEVICE FELT INTO HER ENDOMETRIUM (DEVICE IN ENDOMETRIUM CAVITY). ACCORDING TO FOLLOW UP INFORMATION, HER PHYSICIAN PERFORMED A SURGERY TO REMOVE IT. THE REPORTED EVENT WAS CONSIDERED SERIOUS, DUE TO MEDICAL IMPORTANCE AND IS LISTED IN ESSURE'S REFERENCE SAFETY INFORMATION. DURING ESSURE MICRO-INSERT THERAPY THERE IS A RISK THAT THE DEVICE COULD MOVE OUT OF FALLOPIAN TUBES; THIS MOVEMENT COULD BE AN EXPULSION (INTO UTERUS/CERVIX OR OUT OF THE BODY) OR MIGRATION (DISTAL FALLOPIAN TUBE OR PERITONEAL CAVITY). IN THIS PARTICULAR CASE, LIMITED INFORMATION WAS PROVIDED. NEVERTHELESS, GIVEN THE EVENT'S NATURE, CAUSALITY WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS CONSIDERED AN INCIDENT, SINCE AN INTERVENTION WAS REQUIRED FOR ESSURE REMOVAL. THE PRODUCT TECHNICAL ANALYSIS (WITH LOT NUMBER) CONCLUDED THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT.

    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 (B)(6) 2015 WHICH REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) ON AN UNSPECIFIED DATE. PHYSICIAN IS GOING TO PERFORM SURGERY TO REMOVE AN ESSURE DEVICE WHICH FELT INTO THE ENDOMETRIUM. HCP DID NOT INSERT THE DEVICES AND WILL BE PERFORMING A TUBAL. THE PRODUCT TECHNICAL COMPLAINT (PTC) INVESTIGATION AND FINAL ASSESSMENT WERE RECEIVED ON (B)(6) 2015. THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: (B)(4). FINAL ASSESSMENT: 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 TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. NO NEW FAILURE MODE HAS BEEN IDENTIFIED. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A REQUEST FOR CONFIRMATION OF QUALITY. THE REPORTED ADVERSE EVENT IS A KNOWN POSSIBLE UNDESIRABLE EVENT AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO BATCH NUMBER WAS REPORTED. WITHOUT THIS INFORMATION NO BATCH SIGNAL CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE. NEITHER A BATCH NUMBER NOR COMPLAINT SAMPLE WERE PROVIDED FOR A TECHNICAL INVESTIGATION. 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. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND THE DEVICE FELT INTO HER ENDOMETRIUM; HER PHYSICIAN IS GOING TO PERFORM A SURGERY TO REMOVE IT. THE REPORTED EVENT WAS CONSIDERED SERIOUS, DUE TO MEDICAL IMPORTANCE AND IS LISTED IN ESSURE'S REFERENCE SAFETY INFORMATION. DURING ESSURE MICRO-INSERT THERAPY THERE IS A RISK THAT THE DEVICE COULD MOVE OUT OF FALLOPIAN TUBES; THIS MOVEMENT COULD BE AN EXPULSION (INTO UTERUS/CERVIX OR OUT OF THE BODY) OR MIGRATION (DISTAL FALLOPIAN TUBE OR PERITONEAL CAVITY). IN THIS PARTICULAR CASE, LIMITED INFORMATION WAS PROVIDED. NEVERTHELESS, GIVEN THE EVENT'S NATURE, CAUSALITY WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS CONSIDERED AN INCIDENT, SINCE AN INTERVENTION WILL BE REQUIRED FOR ESSURE REMOVAL. THE PRODUCT TECHNICAL ANALYSIS CONCLUDED THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. FOLLOW-UP INFORMATION IS BEING SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346195 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 C91761

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other| R