BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 17981964 · Received October 21, 2023

    Report

    Report Number
    2951250-2023-03130
    Event Type
    Injury
    Date Received
    October 21, 2023
    Date of Event
    March 1, 2022
    Report Date
    November 22, 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 (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("WORKUP SHOWED DISPLACEMENT OF HER ESSURE COILS") IN A 50 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF UTERINE CERVICAL SQUAMOUS METAPLASIA, PARITY, UTERINE FIBROIDS, ABNORMAL UTERINE BLEEDING, PARITY 1 AND GRAVIDA I ON (B)(6) 2022. ON (B)(6) 2022,, SHE EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. THE PATIENT WAS TREATED WITH SURGERY (SINGLE INCISION LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY, CYSTOSCOPY). THE REPORTER CONSIDERED DEVICE DISLOCATION TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [BLOOD CHLORIDE] ON (B)(6) 2021: 110; ON (B)(6) 2021: 109; ON (B)(6) 2022: 108 [CARBON DIOXIDE] ON (B)(6) 2021: 22; ON (B)(6) 2022: 20 [PATHOLOGY TEST] ON (B)(6) 2022: SPECIMEN INFORMATION: UTERUS WITH CERVIX PRE-OP DIAGNOSIS: ABNORMAL UTERINE BLEEDING;INTRAMURAL FIBROCIAS ;DISPLACEMENT OF ESSURE COILS. FINAL DIAGNOSIS: UTERUS AND FALLOPIAN TUBES, EXCISION: CERVIX- CIN, FOCAL (DYSPLASIA OF SQUAMOUS MUCOSA) - INVOLVING SUPERFICIAL ENDOCERVICAL GLAND - GRADE INDETERMINATE - AT T ZONE REMOTE TO MARGIN - NEGATIVE FOR INVASIVE MALIGNANCY SQUAMOUS METAPLASIA CHRONIC INFLAMMATION NABOTHIAN CYSTS ENDOMETRIUM:NO PATHOLOGICAL DIAGNOSIS PROLIFERATIVE PATTERN ESSURE COILS AS GROSSLY DESCRIBED MYOMETRIUM:LEIOMYOMAS ADENOMYOSIS (POSTERIOR INNER 3RD) FALLOPIAN TUBES:NO PATHOLOGICAL DIAGNOSIS NORMAL CROSS-SECTIONS DEMONSTRATED SEROSA:NO PATHOLOGICAL DIAGNOSIS NEGATIVE FOR ADHESIONS AND ENDOMETRIOSIS GROSS DESCRIPTION: THERE IS AN ESSURE COIL IN THE LOWER UTERINE SEGMENT OF THE ANTERIOR HALF EXTENDING INTO THE ENDOCERVICAL CANAL AND ESSURE COIL IDENTIFIED IN THE RIGHT CORNU. NO ESSURE COIL IS IDENTIFIED IN RIGHT OR LEFT FALLOPIAN TUBES. 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: 14-NOV-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 (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("WORKUP SHOWED DISPLACEMENT OF HER ESSURE COILS") IN A 50 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF UTERINE CERVICAL SQUAMOUS METAPLASIA, NORMAL DELIVERY (LIVE CHILD), UTERINE FIBROIDS, ABNORMAL UTERINE BLEEDING, PARITY 1 AND GRAVIDA I ON (B)(6) 2022. ON (B)(6) 2022,, SHE EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. THE PATIENT WAS TREATED WITH SURGERY (SINGLE INCISION LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY, CYSTOSCOPY). THE REPORTER CONSIDERED DEVICE DISLOCATION TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [BLOOD CHLORIDE] ON (B)(6) 2021: 110; ON (B)(6) 2021: 109; ON (B)(6) 2022: 108. [CARBON DIOXIDE] ON (B)(6) 2021: 22; ON (B)(6) 2022: 20. [PATHOLOGY TEST] ON (B)(6) 2022: SPECIMEN INFORMATION: UTERUS WITH CERVIX PRE-OP DIAGNOSIS: ABNORMAL UTERINE BLEEDING;INTRAMURAL FIBROCIAS ;DISPLACEMENT OF ESSURE COILS. FINAL DIAGNOSIS: UTERUS AND FALLOPIAN TUBES, EXCISION: CERVIX- CIN, FOCAL (DYSPLASIA OF SQUAMOUS MUCOSA) - INVOLVING SUPERFICIAL ENDOCERVICAL GLAND, - GRADE INDETERMINATE, - AT T ZONE REMOTE TO MARGIN, - NEGATIVE FOR INVASIVE MALIGNANCY. SQUAMOUS METAPLASIA, CHRONIC INFLAMMATION, NABOTHIAN CYSTS, ENDOMETRIUM:NO PATHOLOGICAL DIAGNOSIS. PROLIFERATIVE PATTERN. ESSURE COILS AS GROSSLY DESCRIBED. MYOMETRIUM:LEIOMYOMAS ADENOMYOSIS (POSTERIOR INNER 3RD). FALLOPIAN TUBES:NO PATHOLOGICAL DIAGNOSIS. NORMAL CROSS-SECTIONS DEMONSTRATED. SEROSA:NO PATHOLOGICAL DIAGNOSIS. NEGATIVE FOR ADHESIONS AND ENDOMETRIOSIS. GROSS DESCRIPTION: THERE IS AN ESSURE COIL IN THE LOWER UTERINE SEGMENT OF THE ANTERIOR HALF EXTENDING INTO THE ENDOCERVICAL CANAL AND ESSURE COIL IDENTIFIED IN THE RIGHT CORNU. NO ESSURE COIL IS IDENTIFIED IN RIGHT OR LEFT FALLOPIAN TUBES. 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 WAS 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
    1996059 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention