BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 16991256 · Received May 24, 2023

    Report

    Report Number
    2951250-2023-02374
    Event Type
    Injury
    Date Received
    May 24, 2023
    Date of Event
    April 26, 2021
    Report Date
    October 27, 2023
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 39 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF CHOLECYSTECTOMY, TUBAL LIGATION, DYSMENORRHEA, UTERINE FIBROID, PELVIC PAIN FEMALE, SHOULDER PAIN, GASTROESOPHAGEAL REFLUX DISEASE, OBESITY (BMI 30-39.9) AND PNEUMONIA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: TYLENOL. ON (B)(6) 2019, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2021, 573 DAYS AFTER ESSURE INSERTION, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [PATHOLOGY TEST] ON (B)(6) 2021: ANATOMIC PATHOLOGY REPORT: DIAGNOSIS: UTERUS, CERVIX, BILATERAL FALLOPIAN TUBES AND ESSURE COILS, VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY: CERVIX: BENIGN ECTOCERVICAL SQUAMOUS MUCOSA AND BENIGN ENDOCERVICAL GLANDULAR MUCOSA. ENDOMYOMETRIUM: SECRETORY PATTERN ENDOMETRIUM. LEIOMYOMA. FALLOPIAN TUBES: UNREMARKABLE FALLOPIAN TUBES; BILATERAL. SEGMENTS OF METALLIC MATERIAL, CONSISTENT WITH ESSURE COILS (GROSS EXAMINATION). PERITONEAL CALCIFICATIONS, EXCISIONAL BIOPSY: FIBROUS CAPSULE WITH CALCIFICATIONS. GROSS DESCRIPTION: SECTIONING REVEALS A LUMEN WHICH CONTAINS METALLIC SPRINGLIKE MATERIAL LOCATED IN MOST OF THE LUMEN. RECEIVED SEPARATE IN THE CONTAINER IS A SEGMENT OF METALLIC SPRINGLIKE MATERIAL MEASURING 1 CM IN LENGTH AND 0.3 CM IN DIAMETER. [ULTRASOUND PELVIS] ON (B)(6) 2021: FINDINGS: SHADOWING ECHOGENIC FOCI IN THE UTERINE FUNDUS BILATERALLY ARE COMPATIBLE WITH PARTIAL VISUALIZATION OF THE REPORTED ESSURE WIRES. IMPRESSION: COMPLEX RIGHT OVARIAN CYST AND LEFT OVARIAN FOLLICLE. FOLLOW-UP PELVIC SONOGRAPHY IS RECOMMENDED IN 2-3 MENSTRUAL CYCLES OR MONTHS TO ASSESS FOR INTERVAL CHANGE OR RESOLUTION. RETROVERTED UTERUS WITH SUGGESTION OF A SMALL INTRAMURAL FIBROID IN THE POSTERIOR RIGHT UTERINE BODY. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED, AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 29-SEP-2023: MEDICAL RECORD RECEIVED .MEDICAL HISTORY AND LAB DATA ADDED INCLUDING PATHOLOGY TEST. REPORTER INFORMATION ADDED. INDICATION ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 0

    THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 39 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2019, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2021, 573 DAYS AFTER ESSURE INSERTION, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY - UTERUS). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED, AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1448330 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention