BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7685968 · Received July 13, 2018

    Report

    Report Number
    2951250-2018-03035
    Event Type
    Injury
    Date Received
    July 13, 2018
    Date of Event
    April 10, 2017
    Report Date
    August 16, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FEMALE SUBJECT WAS ENROLLED IN A COMPANY-SPONSORED INTERVENTIONAL STUDY TITLED "USE OF TRANSVAGINAL ULTRASOUND TO CONFIRM ESSURE MICRO-INSERT PLACEMENT IN WOMEN: DEMONSTRATION OF EFFECTIVENESS" (PROTOCOL: 16974). THE SUBJECT (PATIENT ID: 07012) HAD FALLOPIAN TUBE OCCLUSION INSERT (BATCH NO. 904748) INSERTED. THE REPORT DESCRIBES A CASE OF MEDICAL DEVICE REMOVAL ("DEVICE REMOVAL"). THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE SUBJECT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ON (B)(6) 2015, THE SUBJECT EXPERIENCED HYPOTHYROIDISM ("HYPOTHYREODIA"). ON (B)(6) 2017, THE SUBJECT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE SUBJECT WAS TREATED WITH SURGERY (SALPINGECTOMY BY LAPAROSCOPIC). FALLOPIAN TUBE OCCLUSION INSERT WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN AND THE HYPOTHYROIDISM HAD NOT RESOLVED. THE RELATIONSHIP OF MEDICAL DEVICE REMOVAL TO TREATMENT WITH FALLOPIAN TUBE OCCLUSION INSERT WAS NOT REPORTED. THE INVESTIGATOR CONSIDERED HYPOTHYROIDISM TO BE UNRELATED TO FALLOPIAN TUBE OCCLUSION INSERT. THE REPORTER COMMENTED: INSERTION DETAILS: BOTH TUBAL OSTIA WERE VISUALIZED. PROCEDURE TOOK 7 MINUTES. FIVE TRAILING COILS WERE SEEN ON BOTH SIDES AFTER INSERTION. THE PRIMARY REASON FOR DEVICE REMOVAL WAS: SUBJECT REQUEST. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST URINE - ON (B)(6) 2012: NEGATIVE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-AUG-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.

    Description of Event or Problem · 1

    ALE SUBJECT WAS ENROLLED IN A COMPANY-SPONSORED INTERVENTIONAL STUDY TITLED "USE OF TRANSVAGINAL ULTRASOUND TO CONFIRM ESSURE MICRO-INSERT PLACEMENT IN WOMEN: DEMONSTRATION OF EFFECTIVENESS" (PROTOCOL: 16974). THE SUBJECT (PATIENT ID: (B)(6)) HAD FALLOPIAN TUBE OCCLUSION INSERT (BATCH NO. 904748) INSERTED. THE REPORT DESCRIBES A CASE OF MEDICAL DEVICE REMOVAL ("DEVICE REMOVAL"). THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE SUBJECT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ON (B)(6) 2015, THE SUBJECT EXPERIENCED HYPOTHYROIDISM ("HYPOTHYREODIA"). ON (B)(6) 2017, THE SUBJECT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE SUBJECT WAS TREATED WITH SURGERY (SALPINGECTOMY BY LAPAROSCOPIC). FALLOPIAN TUBE OCCLUSION INSERT WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN AND THE HYPOTHYROIDISM HAD NOT RESOLVED. THE RELATIONSHIP OF MEDICAL DEVICE REMOVAL TO TREATMENT WITH FALLOPIAN TUBE OCCLUSION INSERT WAS NOT REPORTED. THE INVESTIGATOR CONSIDERED HYPOTHYROIDISM TO BE UNRELATED TO FALLOPIAN TUBE OCCLUSION INSERT. THE REPORTER COMMENTED: INSERTION DETAILS: BOTH TUBAL OSTIA WERE VISUALIZED. PROCEDURE TOOK 7 MINUTES. FIVE TRAILING COILS WERE SEEN ON BOTH SIDES AFTER INSERTION. THE PRIMARY REASON FOR DEVICE REMOVAL WAS: SUBJECT REQUEST. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST URINE - ON (B)(6) 2012: (B)(6). THE LIST OF SIMILAR CASES CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS WITH SIMILAR EVENTS CODED IN MEDDRA. APPROXIMATELY IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON (B)(6)2018 FOR THE FOLLOWING MEDDRA PREFERRED TERM: MEDICAL DEVICE REMOVAL. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 865 CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THIS MEDDRA PT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529329 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 904748 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R