BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8495039 · Received April 9, 2019

    Report

    Report Number
    2951250-2019-01330
    Event Type
    Injury
    Date Received
    April 9, 2019
    Report Date
    April 9, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("ONE HSG EVIDENCED AN UNSATISFACTORY LOCATION BECAUSE OF THE RIGHT INSERT BEING IN A TRANSFIXING INTRAUTERINE POSITION") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR BIRTH CONTROL. LITERATURE REFERENCE: PETIT C, VERNET T, VERPILLAT P, RUBOD C, COSSON M, GIRAUDET G, RADIOLOGICAL ASSESSMENT OF THE PLACEMENT OF ESSURE(®) IN ORDER TO REDUCE HYSTEROSALPINGOGRAPHY: PELVIC X-RAY VERSUS COMBINED PELVIC X-RAY AND ULTRASOUND, JOURNAL OF GYNECOLOGY OBSTETRICS AND HUMAN REPRODUCTION, 2017, 46:8:623-628. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "PERSISTENT UNILATERAL TUBAL PERMEABILITY". ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). AT THE TIME OF THE REPORT, THE UTERINE PERFORATION OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR UTERINE PERFORATION WITH ESSURE. THE REPORTER COMMENTED: THIS CASE REFERS TO A PATIENT IN SINGLE X-RAY GROUP: ONE HSG EVIDENCED AN UNSATISFACTORY LOCATION BECAUSE OF THE RIGHT INSERT BEING IN A TRANSFIXING INTRAUTERINE POSITION, WHICH RESULTED IN PERSISTENT UNILATERAL TUBAL PERMEABILITY. ABSTRACT OBJECTIVE: THREE MONTHS AFTER HYSTEROSCOPIC STERILISATION WITH ESSURE, A CONFIRMATION TEST IS REQUIRED TO EVALUATE THE CORRECT LOCATION OF THE INSERTS. THE TEST MAY BE CONDUCTED USING A PELVIC ULTRASOUND (2D OR 3D) OR AN ABDOMINAL X-RAY. SHOULD THE LOCATION NOT LOOK SATISFACTORY ON THESE TESTS, A FOLLOW-UP HYSTEROSALPINGOGRAPHY (HSG) WOULD BE REQUIRED. THE OBJECTIVE OF OUR STUDY IS TO ASSESS WHETHER THE ESSURE 3-MONTH CONFIRMATION TEST USING A SINGLE X-RAY OR A COMBINATION OF X-RAY AND ULTRASOUND COULD REDUCE THE USE OF HSG. STUDY DESIGN: THIS RETROSPECTIVE STUDY EXAMINED PATIENTS WHO UNDERWENT BIRTH CONTROL ESSURE PROCEDURE BETWEEN 2009 AND 2015 IN THE GYNAECOLOGICAL SURGERY DEPARTMENT AT THE REGIONAL UNIVERSITY HOSPITAL CENTRE (CHRU) IN LILLE. WE DIVIDED PATIENTS INTO TWO GROUPS BASED ON THE IMAGING TESTS PERFORMED: SINGLE X-RAY (2009-2010) VERSUS X-RAY AND PELVIC ULTRASOUND (2014-2015). WE THEN COMPARED THE RESULTS OF THE IMAGING TESTS AND THE USE OF HSG BETWEEN THE TWO GROUPS. RESULTS: ONE HUNDRED AND THIRTY-FOUR PATIENTS WERE TESTED, OF WHICH 60 (44.8%) USING A SINGLE X-RAY AND 74 (55.2%) USING A COMBINATION OF X-RAY AND ULTRASOUND. WE NOTE THAT THE COMBINED X-RAY/ULTRASOUND TEST REDUCES SIGNIFICANTLY THE NUMBER OF HSG PERFORMED (26.7% VERSUS 12.2%, P = 0.04). CONCLUSION COMPARED TO A SINGLE X-RAY, THE COMBINATION OF X-RAY AND ULTRASOUND ENABLES TO SIGNIFICANTLY LIMIT THE USE OF HSG. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINTS RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289206 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other