BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 18226678 · Received November 29, 2023

    Report

    Report Number
    2951250-2023-03429
    Event Type
    Injury
    Date Received
    November 29, 2023
    Date of Event
    October 2, 2017
    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 (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 39 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 922613) FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF PARITY 2, MULTI GRAVIDA, PELVIC PAIN, ABDOMINAL PAIN, HEMORRHOIDS, ABNORMAL UTERINE BLEEDING, INTERMENSTRUAL BLEEDING AND DYSMENORRHEA. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2017, 2028 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 (LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMIES.UTEROSACRAL COLPOPEXY CYSTOSCOPY). 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: 23.14 KG/SQM. [PATHOLOGY TEST] ON (B)(6) 2017: SPECIMEN: UTERUS, CERVIX, FALLOPIAN TUBES, UTERUS, CERVIX, BILATERAL FALLOPIAN TUBES. FINAL DIAGNOSIS: UTERUS, BILATERAL FALLOPIAN TUBES, HYSTERECTOMY AND BILATERAL SALPINGECTOMY: CHRONIC CERVICITIS. SCANT BENIGN ENDOMETRIUM AND ENDOMETRIAL SCARRING. UNREMARKABLE MYOMETRIUM. UNREMARKABLE FALLOPIAN TUBES. ESSURE COILS IDENTIFIED. CLINICAL INFORMATION: PELVIC PAIN IN FEMALE. ENSURE TWO BILATERAL TUBES. GROSS DESCRIPTION: THE RIGHT FIMBRIATED FALLOPIAN TUBE IS 6.1 CM IN LENGTH AND RANGES IN DIAMETER FROM 0.4 AND 0.8 CM. THE LEFT FIMBRIATED FALLOPIAN TUBE IS 6.2 CM IN LENGTH AND RANGES IN DIAMETER FROM 0.6 AND 1.0 CM. BOTH FALLOPIAN TUBES ARE PURPLE AND SMOOTH. WITHIN THE NON-FIMBRIATED END OF EACH FALLOPIAN TUBE AND EXTENDING INTO THE CORNU OF THE UTERUS ARE TWO INTACT SILVER COLORED ESSURE COILS, EACH 2.5 X 0.1CM. BOTH ESSURE COILS ARE IN THE CORRECT ANATOMICAL LOCATION. LOT NUMBER: 922613. MANUFACTURE DATE: 2011-11. EXPIRATION DATE: 2014-11. 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 (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 39 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 922613) FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF PARITY 2, MULTI GRAVIDA, PELVIC PAIN, ABDOMINAL PAIN, HEMORRHOIDS, ABNORMAL UTERINE BLEEDING, INTERMENSTRUAL BLEEDING AND DYSMENORRHEA. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2017, 2028 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 (LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMIES.UTEROSACRAL COLPOPEXY CYSTOSCOPY). 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: 23.14 KG/SQM. [PATHOLOGY TEST] ON (B)(6) 2017: SPECIMEN: UTERUS, CERVIX, FALLOPIAN TUBES, UTERUS, CERVIX, BILATERAL FALLOPIAN TUBES FINAL DIAGNOSIS A. UTERUS, BILATERAL FALLOPIAN TUBES, HYSTERECTOMY AND BILATERAL SALPINGECTOMY: CHRONIC CERVICITIS. SCANT BENIGN ENDOMETRIUM AND ENDOMETRIAL SCARRING. UNREMARKABLE MYOMETRIUM. UNREMARKABLE FALLOPIAN TUBES. ESSURE COILS IDENTIFIED CLINICAL INFORMATION: PELVIC PAIN IN FEMALE. ENSURE TWO BILATERAL TUBES. GROSS DESCRIPTION: THE RIGHT FIMBRIATED FALLOPIAN TUBE IS 6.1 CM IN LENGTH AND RANGES IN DIAMETER FROM 0.4 AND 0.8 CM. THE LEFT FIMBRIATED FALLOPIAN TUBE IS 6.2 CM IN LENGTH AND RANGES IN DIAMETER FROM 0.6 AND 1.0 CM. BOTH FALLOPIAN TUBES ARE PURPLE AND SMOOTH. WITHIN THE NON-FIMBRIATED END OF EACH FALLOPIAN TUBE AND EXTENDING INTO THE CORNU OF THE UTERUS ARE TWO INTACT SILVER COLORED ESSURE COILS, EACH 2.5 X 0.1CM. BOTH ESSURE COILS ARE IN THE CORRECT ANATOMICAL LOCATION. 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 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
    78346 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 922613 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention