BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4322535 · Received December 11, 2014

    Report

    Report Number
    2951250-2014-00522
    Event Type
    Injury
    Date Received
    December 11, 2014
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    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 SOCIAL MEDIA CASE REPORT RECEIVED FROM A FEMALE CONSUMER OF UNSPECIFIED AGE IN (B)(6) 2014 WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED ON AN UNSPECIFIED DATE. SHE REPORTED THAT ESSURE TOOK HER TUBES. PTC INVESTIGATION RESULT RECEIVED ON (B)(6) 2014. 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 CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR AND INSPECT THE DEVICE 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. THIS IS AN ANTICIPATED EVENT. 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. 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. THE LIST OF SIMILAR CASES CONTAINS REPORTS WITH SIMILAR EVENTS CODED IN (B)(4). 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)(6) 2014 FOR THE FOLLOWING (B)(4) PREFERRED TERM: SALPINGECTOMY. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 7 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 NON-MEDICALLY CONFIRMED, SOCIAL MEDIA CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND ESSURE TOOK HER TUBES. THE REPORTED EVENT WAS CONSIDERED SERIOUS, DUE TO MEDICAL IMPORTANCE AND LISTED IN ESSURE'S REFERENCE SAFETY INFORMATION. IF, AFTER ESSURE INSERTION, REMOVAL OF THE MICRO-INSERT IS NECESSARY, SURGERY (SALPINGECTOMY OR HYSTERECTOMY) MAY BE REQUIRED. IN THIS PARTICULAR CASE, ALTHOUGH THE EXACT REASON FOR ESSURE REMOVAL WAS NOT SPECIFIED, SINCE REPORTER REGARDED THE EVENTS AS A CONSEQUENCE OF ESSURE USE AND NO FOLLOW-UP WILL BE POSSIBLE (SOCIAL MEDIA CASE); COMPANY CONSIDERS A CAUSAL RELATIONSHIP BETWEEN THE REPORTED EVENTS AND ESSURE THERAPY CANNOT BE EXCLUDED AND DUE TO THE SURGICAL INTERVENTION THIS CASE WAS CONSIDERED AN INCIDENT. THE PRODUCT TECHNICAL ANALYSIS CONCLUDED UNCONFIRMED QUALITY REPORT. THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806213 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R