BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 17920162 · Received October 12, 2023

    Report

    Report Number
    2951250-2023-03079
    Event Type
    Injury
    Date Received
    October 12, 2023
    Date of Event
    July 7, 2022
    Report Date
    November 1, 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 ("ESSURE REMOVAL") IN A 47 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF NEPHROLITHIASIS IN 2011 AND DYSFUNCTIONAL UTERINE BLEEDING, RASH, FATIGUE, VOMITING, NAUSEA, DRUG ALLERGY, YEAST INFECTION, MIGRAINE, GENITAL WARTS, FIBROMYALGIA, DEPRESSION, ASTHMA, ALLERGIC RHINITIS, WEIGHT GAIN, MOOD SWINGS, HEAVY PERIODS, ANEMIA AND DYSFUNCTIONAL UTERINE BLEEDING. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: OTHER THERAPEUTIC PRODUCTS. ESSURE WAS REMOVED ON (B)(6) 2022. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY DONE ON (B)(6) 2022). THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [HAEMOGLOBIN] IN (B)(6) 2021: 10.3 [PATHOLOGY TEST] ON (B)(6) 2022: 1 UTERUS WITH OR WITHOUT OVARIES/TUBES, NOT FOR TUMOR, A. UTERUS WITH RIGHT AND LEFT FALLOPIAN TUBES 1. UTERUS WITH CERVIX, BILATERAL FALLOPIAN TUBES, HYSTERECTOMY WITH BILATERAL SALPINGECTOMY: INACTIVE PATTERN ENDOMETRIUM, WITH ENDOMETRIAL POLYP. CERVIX WITH SQUAMOUS METAPLASIA. FALLOPIAN TUBES (INCLUDING FIMBRIAE) WITH NO ABNORMALITY IDENTIFIED. NEGATIVE FOR FEATURES OF MALIGNANCY. GROSS DESCRIPTION: CERVIX WITH SEPARATE FIMBRIATED FALLOPIAN TUBES. ONE OF THE TUBES IS FRAGMENTED. THE TUBES ARE 4.5 CM AND 5.0 CM IN LENGTH WITH A DIAMETER MEASURING UP TO 0.8 CM. [SERUM FERRITIN] IN (B)(6) 2021: 4 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: 31-OCT-2023: QUALITY SAFETY EVALUATION OF PTC. 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 ("ERRURE REMOVAL") IN A 47 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF NEPHROLITHIASIS IN 2011 AND DYSFUNCTIONAL UTERINE BLEEDING, RASH, FATIGUE, VOMITING, NAUSEA, DRUG ALLERGY, YEAST INFECTION, MIGRAINE, GENITAL WARTS, FIBROMYALGIA, DEPRESSION, ASTHMA, ALLERGIC RHINITIS, WEIGHT GAIN, MOOD SWINGS, HEAVY PERIODS, ANEMIA AND DYSFUNCTIONAL UTERINE BLEEDING. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: ZYRTEC D. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. THE PATIENT WAS TREATED WITH SURGERY (A LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMIES). ON (B)(6) 2022,, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [HAEMOGLOBIN] IN DECEMBER 2021: 10.3. [PATHOLOGY TEST] ON (B)(6) 2022: 1 UTERUS WITH OR WITHOUT OVARIES/TUBES, NOT FOR TUMOR, A. UTERUS WITH RIGHT AND LEFT FALLOPIAN TUBES. 1. UTERUS WITH CERVIX, BILATERAL FALLOPIAN TUBES, HYSTERECTOMY WITH BILATERAL SALPINGECTOMY: INACTIVE PATTERN ENDOMETRIUM, WITH ENDOMETRIAL POLYP. CERVIX WITH SQUAMOUS METAPLASIA. FALLOPIAN TUBES (INCLUDING FIMBRIAE) WITH NO ABNORMALITY IDENTIFIED. NEGATIVE FOR FEATURES OF MALIGNANCY. GROSS DESCRIPTION: CERVIX WITH SEPARATE FIMBRIATED FALLOPIAN TUBES. ONE OF THE TUBES IS FRAGMENTED. THE TUBES ARE 4.5 CM. AND 5.0 CM IN LENGTH WITH A DIAMETER MEASURING UP TO 0.8 CM. [SERUM FERRITIN] IN (B)(6) 2021: 4. 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 WILL BE 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
    2119164 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Other| R