BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7902571 · Received September 24, 2018

    Report

    Report Number
    2951250-2018-04110
    Event Type
    Injury
    Date Received
    September 24, 2018
    Report Date
    September 24, 2018
    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
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("VAGINAL HYSTERECTOMY WITH SALPINGECTOMY FOR ESSURE INSERT REMOVAL") AND URINARY RETENTION ("GRADE 2 URINARY RETENTION") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. LITERATURE REFERENCE: CHARAVIL A, AGOSTINI A, RAMBEAUD C, SCHMITT A, TOURETTE C, CROCHET P. VAGINAL HYSTERECTOMY WITH SALPINGECTOMY FOR ESSURE INSERT REMOVAL. JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY, 2018, XX: 1-7. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED) AND URINARY RETENTION (SERIOUSNESS CRITERION HOSPITALIZATION PROLONGED). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY W/ BILATERAL SALPINGECTOMY FOR ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL AND URINARY RETENTION HAD RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR MEDICAL DEVICE REMOVAL AND URINARY RETENTION WITH ESSURE. THE REPORTER COMMENTED: TWO GRADE 2 POSTOPERATIVE COMPLICATIONS OCCURRED: ONE CASE OF BLEEDING DUE TO A VAGINAL SCAR GRANULOMA TREATED BY APPLICATION WITH SILVER NITRATE DURING A CONSULTATION ON DAY 24 AND 1 CASE OF URINARY RETENTION REQUIRING URINARY CATHETERIZATION FOR 24 HOURS. ESSURE WAS REMOVED WITH NO CONVERSION TO LAPAROTOMY OR LAPAROSCOPY. AN X-RAY OF THE RESECTED SPECIMEN WAS SYSTEMATICALLY PERFORMED PERIOPERATIVELY TO VERIFY THAT BOTH ESSURE INSERTS HAD BEEN FULLY REMOVED. FOLLOW-UP CONSULTATION WAS UNDERTAKEN AT 1 MONTH POSTOPERATIVELY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND SCAN - ON AN UNKNOWN DATE: PROPER LOCATION OF ESSURE X-RAY - ON AN UNKNOWN DATE: ESSURE REMOVAL CONFIRMED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-SEP-2018: AFTER INTERNAL REVIEW, THE EVENT VAGINAL HYSTERECTOMY WITH SALPINGECTOMY FOR ESSURE INSERT REMOVAL WAS ADDED AND THE CASE WAS REGARDED AS INCIDENT. 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
    742344 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R