BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 18204949 · Received November 24, 2023

    Report

    Report Number
    2951250-2023-03402
    Event Type
    Injury
    Date Received
    November 24, 2023
    Report Date
    January 31, 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 CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PERSISTENT PELVIC PAIN, PAIN WORSE ON THE LEFT, MAKES HER CRAZY") IN A 27 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 893038, A15529) FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF RETROVERTED UTERUS (BOGGY), ADENOMYOSIS, DYSFUNCTIONAL UTERINE BLEEDING, DYSPAREUNIA (RATES 8/10), OVARIAN CYST AND MULTIPAROUS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: ORAL CONTRACEPTIVE NOS. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED: SIDE EFFECTS WITH ORAL CONTRACEPTIVE NOS. ESSURE WAS REMOVED ON (B)(6) 2017. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ESSURE REMOVAL VAGINAL HYSTERECTOMY WITH LEFT SALPINGECTOMY). THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX: 23.6 KG/SQM. [LAPAROSCOPY] ON (B)(6) 2017: EXAM UNDER ANESTHESIA REVEALED A MOBILE RETROVERTED UTERUS WITH MULTIPAROUS CERVIX APPROXIMATELY 6 WEEKS IN SIZE. NO PALPABLE ADNEXAL MASSES. [ULTRASOUND SCAN] (DATE UNKNOWN): A SEPTATED SMALL RIGHT FOLLICLE MEASURING 18 MM, BUT NO OTHER MASSES LOT NUMBER:893038 MANUFACTURE DATE:2012-03 EXPIRATION DATE: 2015-03 LOT NUMBER: A15529 MANUFACTURE DATE:2012-10 EXPIRATION DATE: 2015-10. 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: 31-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 CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PERSISTENT PELVIC PAIN, PAIN WORSE ON THE LEFT, MAKES HER CRAZY") IN A 27 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. LEFT A15529 ,RIGHT 893038) FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF RETROVERTED UTERUS (BOGGY), ADENOMYOSIS, DYSFUNCTIONAL UTERINE BLEEDING, DYSPAREUNIA (RATES (B)(4)), OVARIAN CYST AND MULTIPAROUS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: ORAL CONTRACEPTIVE NOS. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED: SIDE EFFECTS WITH ORAL CONTRACEPTIVE NOS. ESSURE WAS REMOVED ON (B)(6). ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE SHE EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC ESSURE REMOVAL VAGINAL HYSTERECTOMY WITH LEFT SALPINGECTOMY). THE REPORTER CONSIDERED PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX: 23.6 KG/SQM. [LAPAROSCOPY] ON (B)(6) 2017: PREOPERATIVE DIAGNOSIS: 1. CHRONIC PELVIC PAIN.2. DYSFUNCTIONAL UTERINE BLEEDING. 3. SUSPECTED ADENOMYOSIS. PROCEDURE: LAPAROSCOPIC-ASSISTED VAGINAL HYSTERECTOMY WITH LEFT SALPINGECTOMY. COMPLICATIONS: NONE.CONDITION: STABLE.PATHOLOGY: UTERUS, CERVIX, AND LEFT FALLOPIAN TUBE. FINDINGS: EXAM UNDER ANESTHESIA REVEALED A MOBILE RETROVERTED UTERUS WITH MULTIPAROUS CERVIX APPROXIMATELY 6 WEEKS IN SIZE. NO PALPABLE ADNEXAL MASSES. INTRAOPERATIVE FINDINGS REVEALED ANTERIOR POSTERIOR CUL-DE-SAC FREE OF ANY LESIONS OR ABNORMALITIES. RETROVERTED BOGGY UTERUS. THE RIGHT FALLOPIAN TUBE WAS SURGICALLY ABSENT. THE LEFT FALLOPIAN TUBE WAS NORMAL, STATUS POST A PREVIOUS SALPINGECTOMY. BOTH OVARIES WERE WITHOUT LESIONS OR ABNORMALITIES. NORMAL APPENDIX.POST HYSTERECTOMY, BOTH URETERS WERE PERISTALSING WELL. PROCEDURE: THE RIGHT FALLOPIAN TUBE DID APPEAR SOMEWHAT DISTENDED AND FIRM. THE CORNUAL REGION WAS THEN CAUTERIZED AND TRANSECTED. THE ESSURE DEVICE STARTED COMING WITH THE TUBE. / GRASPED THE ESSURE DEVICE AND PULLED IT THROUGH. IT DID BREAK AND HAD TO BE REMOVED IN 2 SECTIONS. THE FOLEY CATHETER WAS NOW DRAINING CLEAR URINE, AND THIS WAS ALSO REMOVED. THE PATIENT TOLERATED THE PROCEDURE WELL. SPONGE, LAPAROTOMY PAD, NEEDLE AND INSTRUMENT COUNTS WERE CORRECT TIMES 2 SPECIMEN: RIGHT FALLOPIAN TUBE AND ESSURE COIL [ULTRASOUND SCAN] (DATE UNKNOWN): A SEPTATED SMALL RIGHT FOLLICLE MEASURING 18 MM, BUT NO OTHER MASSES 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
    1239605 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 893038, A15529 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female Required Intervention