BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 16545107 · Received March 15, 2023

    Report

    Report Number
    2951250-2023-01283
    Event Type
    Injury
    Date Received
    March 15, 2023
    Date of Event
    June 1, 2018
    Report Date
    November 23, 2023
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 EMBEDDED DEVICE ("DEMONSTRATES EMBEDDED SILVER METALLIC COILED WIRE SEGMENTS") IN A 36 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF DYSMENORRHEA, MENOMETRORRHAGIA, PARITY 2, GRAVIDA II, ENDOMETRIOSIS, OVARIAN CYST AND PELVIC PAIN. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ESSURE WAS REMOVED ON (B)(6) 2018. AN UNKNOWN TIME LATER SHE EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY, UTEROSACRAL COLPOSUSPENSION, LEFT URETEROSCOPY BILATERAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED EMBEDDED DEVICE TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: MORE THAN ONE ESSURE RELATED SURGERY-NO. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX: 24.342 KG/SQM. [PATHOLOGY TEST] ON (B)(6) 2018: CLINICAL HISTORY: STRESS INCONTINENCE. PROCEDURE/FINDINGS: ROBOT ASSIST HYSTERECTOMY. SPECIMENS: UTERUS, CERVIX, BILATERAL TUBES. FINAL DIAGNOSIS: UTERUS, CERVIX, BILATERAL FALLOPIAN TUBES: CERVIX: NO SPECIFIC PATHOLOGIC CHANGE. ENDOMETRIUM: PROLIFERATIVE ENDOMETRIUM WITH FEATURES OF ANOVULATION. MYOMETRIUM: NO SPECIFIC PATHOLOGIC CHANGE. SEROSA: NO SPECIFIC PATHOLOGIC CHANGE. RIGHT FALLOPIAN TUBE: NO SPECIFIC PATHOLOGIC CHANGE. LEFT FALLOPIAN TUBE: PARATUBAL CYSTS. GROSS DESCRIPTION: THE RIGHT FALLOPIAN TUBE IS 5.5 CM AND THE LEFT FALLOPIAN TUBE IS 5.5 CM IN LENGTH. SECTIONING OF THE FALLOPIAN TUBES DEMONSTRATES EMBEDDED SILVER METALLIC COILED WIRE SEGMENTS THAT ARE CONSISTENT WITH ESSURE DEVICES. [ULTRASOUND PELVIS] ON (B)(6) 2014: WAS NEGATIVE AS WELL AS WITH THE INCIDENTAL FUNCTIONAL OVARIAN CYSTS SEEN. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: DEVICE EMBEDDED. 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: 02-NOV-2023: MEDICAL DEVICE REMOVAL WAS UPDATE TO EMBEDDED DEVICE. REPORTERS, MEDICAL HISTORY, PATIENT INFORMATION, LAB DATA, REMOVAL DATE, AND NON DRUG TREATMENT 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.

    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 36 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2018, 3073 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 (ESSURE REMOVAL SURGERY). 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. THE REPORTER COMMENTED: MORE THAN ONE ESSURE RELATED SURGERY: NO. 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: 11-APR-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 ("MEDICAL DEVICE REMOVAL") IN A 36 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2018, 3073 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 (ESSURE REMOVAL SURGERY). 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 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
    757199 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention