BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 18083083 · Received November 7, 2023

    Report

    Report Number
    2951250-2023-03267
    Event Type
    Injury
    Date Received
    November 7, 2023
    Date of Event
    May 2, 2023
    Report Date
    January 19, 2024
    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 33 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 12429135) FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF GRAVIDA I (GRAVIDA 1,) AND NULLIPAROUS (PARA 0, AT 40 AND 6/7 THE WEEKS' GESTATION WHO PRESENTED FOR INDUCTION SECONDARY TO POST TERM PREGNANCY WITH MACROSOMIA.) IN 2006 AND OBESITY (BMI 31.641), ENDOMETRIOSIS, LATEX ALLERGY, C-SECTION, APPENDECTOMY, PHYSICAL EXAMINATION (NOTED HER TO BE GRAVID WITH AN APPROXIMATELY 9 POUND ABDOMEN. SHE WAS CONTRACTING EVERY 2-6 MINUTES IRREGULARLY. FETAL HEART RATE TRACING WAS REACTIVE. CERVIX WAS 3-4 CM. DILATED WITH A BULGING BAG OF WATER.), MULTIPLE ALLERGIES (NO KNOWN DRUG ALLERGIES.), URINARY TRACT INFECTION AND PREGNANCY (EARLY ENTRANT HISTORY OF CHLAMYDIA IN OCT2005 TEEN PREGNANCY WITH SOCIAL SUPPORTS PRESENT BACTERIAL VAGINOSIS MACROSOMIA WITH EFW OF GREATER THAN 4000 GRAMS GROUP BETA STREP NEGATIVE). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2023, 4779 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 (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, ENTEROLYSIS, CYSTOSCOPY). 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): BODY MASS INDEX: 31.641 KG/SQM. [PATHOLOGY TEST] ON (B)(6) 2023: UTERUS, BILATERAL FALLOPIAN TUBES AND OVARIES, TOTAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY: · UNREMARKABLE UTERINE CERVIX. · WEAKLY PROLIFERATIVE ENDOMETRIUM WITH A SMALL ENDOMETRIAL POLYP. · UNREMARKABLE MYOMETRIUM. · FIBROUS ADHESIONS OF ANTERIOR UTERINE SEROSA. · UNREMARKABLE BILATERAL FALLOPIAN TUBES WITH MULTIPLE SMALL PARATUBAL CYSTS AND WALTHARD RESTS. · BILATERAL OVARIES WITH FOLLICULAR CYSTS AND FOCAL SURFACE FIBROUS ADHESIONS. ENDOMETRIOSIS; TLH, BSO, ENTEROLYSIS, CYSTOSCOPY. PATIENT WANTS THE ESSURE COILS RETURNED TO HER. ORGAN OR TISSUE: UTERUS, CERVIX, BILATERAL FALLOPIAN TUBES + OVARIES GROSS DESCRIPTION: "UTERUS, CERVIX, BILATERAL FALLOPIAN TUBE AND OVARIES".- THERE ARE METAL COILED WIRES IN THE PROXIMAL SEGMENTS OF BOTH FALLOPIAN TUBES. [PREGNANCY TEST URINE] ON (B)(6) 2023: NEGATIVE LOT NUMBER:12429135,MANUFACTURE DATE: 2010-01,EXPIRATION DATE: 2012-10. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. 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 COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 19-JAN-2024: QUALITY SAFETY EVALUATION OF PTC. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS 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 33 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 12429135) FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF GRAVIDA I (GRAVIDA 1,) AND NULLIPAROUS (PARA 0, AT 40 AND 6/7 THE WEEKS' GESTATION WHO PRESENTED FOR INDUCTION SECONDARY TO POST TERM PREGNANCY WITH MACROSOMIA.) IN 2006 AND ENDOMETRIOSIS, URINARY TRACT INFECTION AND PREGNANCY (EARLY ENTRANT HISTORY OF CHLAMYDIA IN (B)(6) 2005 TEEN PREGNANCY WITH SOCIAL SUPPORTS PRESENT BACTERIAL VAGINOSIS MACROSOMIA WITH EFW OF GREATER THAN 4000 GRAMS GROUP BETA STREP NEGATIVE). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2023, 4779 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 (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, ENTEROLYSIS, CYSTOSCOPY). 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): BODY MASS INDEX: 31.641 KG/SQM. [PATHOLOGY TEST] ON (B)(6) 2023: UTERUS, BILATERAL FALLOPIAN TUBES AND OVARIES, TOTAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY: UNREMARKABLE UTERINE CERVIX. WEAKLY PROLIFERATIVE ENDOMETRIUM WITH A SMALL ENDOMETRIAL POLYP. UNREMARKABLE MYOMETRIUM. FIBROUS ADHESIONS OF ANTERIOR UTERINE SEROSA. UNREMARKABLE BILATERAL FALLOPIAN TUBES WITH MULTIPLE SMALL PARATUBAL CYSTS AND WALTHARD RESTS. BILATERAL OVARIES WITH FOLLICULAR CYSTS AND FOCAL SURFACE FIBROUS ADHESIONS. ENDOMETRIOSIS; TLH, BSO, ENTEROLYSIS, CYSTOSCOPY. PATIENT WANTS THE ESSURE COILS RETURNED TO HER. ORGAN OR TISSUE: UTERUS, CERVIX, BILATERAL FALLOPIAN TUBES + OVARIES GROSS DESCRIPTION: "UTERUS, CERVIX, BILATERAL FALLOPIAN TUBE AND OVARIES".- THERE ARE METAL COILED WIRES IN THE PROXIMAL SEGMENTS OF BOTH FALLOPIAN TUBES. [PREGNANCY TEST URINE] ON (B)(6) 2023: NEGATIVE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT 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
    339466 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 12429135 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention