BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7053049 · Received November 22, 2017

    Report

    Report Number
    2951250-2017-06852
    Event Type
    Injury
    Date Received
    November 22, 2017
    Report Date
    November 22, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF DEVICE TOWARDS THE CAVITY") IN A FEMALE PATIENT WHO HAD ESSURE 305 INSERTED. LITERATURE REFERENCE: CABEZAS-PALACIOS MN; JIMENEZ-CARABALLO A; TATO-VARELA S; SANCHEZ-SANCHEZ A; ROMERO-DIAZ C; CARRASCO-GALLEGO A; ZAPARDIEL-GUTIERREZ I, SAFETY AND PATIENTS' SATISFACTION AFTER HYSTEROSCOPIC STERILISATION, JOURNAL OF OBSTETRICS AND GYNAECOLOGY, 2017, NOT AVAILABLE:1-5. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "DIFFICULT INSERTION" AND DEVICE USE ISSUE "CT SCAN OF THE ABDOMEN SHOWED THE EXISTENCE OF 3 ESSURE DEVICES". ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE 305 INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (EXPLORATORY LAPAROSCOPY FOR DEVICE REMOVAL FROM PELVIC CAVITY). ESSURE 305 WAS REMOVED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION TO BE NOT REPORTED (STUDY) TO ESSURE 305. THE REPORTER COMMENTED: THIS CASE REFERS TO (B)(4) CASE OF MIGRATION OF DEVICE TOWARDS THE CAVITY. THE PATIENT WISHED TO REMOVE THE MIGRATED DEVICE, DESPITE THE LACK OF SYMPTOMS. ANCHOR CASE: 2017-213069. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM - ON AN UNKNOWN DATE: EXISTENCE OF THREE ESSURE DEVICES HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: BILATERAL TUBAL IMPERMEABILITY THE LIST OF SIMILAR CASES CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS WITH SIMILAR EVENTS CODED IN MEDDRA. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON (B)(6) 2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: DEVICE DISLOCATION. THE ANALYSIS IN THE (B)(4) DATABASE REVEALED (B)(4) 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. ABSTRACT: THE AIM OF THIS STUDY WAS TO UNDERSTAND THE POTENTIAL COMPLICATIONS OF THE ESSURE DEVICE AS WELL AS THE FACTORS INFLUENCING ITS ONSET AND PATIENT SATISFACTION. WE PRESENT A (B)(4)-YEAR DESCRIPTIVE PROSPECTIVE STUDY THAT INCLUDED (B)(4) PATIENTS. THE DEVICE WAS PLACED IN (B)(4) OF THEM ((B)(4)); (B)(4) HAD NO PAIN OR MILD PAIN DURING THE INSERTION AND ONLY (B)(4) PATIENTS EXPERIENCED PAIN GREATER THAN MENSTRUAL PAIN. THE PROPORTION OF PATIENTS WITHOUT PAIN WAS GREATER IN THE GROUP THAT TOOK NSAIDS OR NSAIDS AND BZD AND THE UNMEDICATED GROUP HAD THE HIGHEST RATE OF SEVERE PAIN ((B)(4)). IN ALL, (B)(4) OF THE (B)(4) PATIENTS WHO HAD THE ESSURE INSERTED REPORTED HAVING AN ADVERSE EFFECT DURING THE 3-MONTHS POST-INSERTION (PELVIC PAIN OR DISCOMFORT). THE MEAN SCORE OUT OF (B)(4) ATTRIBUTED TO THIS METHOD WAS (B)(4) ((B)(4)). WE CONCLUDED THAT THE ESSURE SHOWS A LOW RATE OF COMPLICATIONS AND USERS SHOWED A HIGH DEGREE OF SATISFACTION. INCIDENT. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. 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
    831561 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R