BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10507020 · Received September 9, 2020

    Report

    Report Number
    2951250-2020-14048
    Event Type
    Injury
    Date Received
    September 9, 2020
    Report Date
    August 5, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION') AND PERFORATION ('PERFORATION') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MIGRAINE ("MIGRAINES/HEADACHES"), IRON DEFICIENCY ANAEMIA ("ANEMIA"), PELVIC PAIN ("WORSENING PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), AUTOIMMUNE DISORDER ("AUTOIMMUNE SYMPTOMS") AND HYPERSENSITIVITY ("HYPERSENSITIVITY "). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD UNDERGONE ESSURE REMOVAL SURGERY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PERFORATION, MIGRAINE, IRON DEFICIENCY ANAEMIA, PELVIC PAIN, GENITAL HAEMORRHAGE, AUTOIMMUNE DISORDER AND HYPERSENSITIVITY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED AUTOIMMUNE DISORDER, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, IRON DEFICIENCY ANAEMIA, MIGRAINE, PELVIC PAIN AND PERFORATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE ALSO ENDED UP NEEDING WOUND CARE WITH DRAINAGE AFTER HER ESSURE REMOVAL SURGERY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-SEP-2020: QSE FOR PRODUCT TECHNICAL COMPLAINT. 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 REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION'), UTERINE PERFORATION ('PERFORATION OF THE ESSURE DEVICE THROUGH THE UTERUS') AND SALPINGITIS ('THE RIGHT FALLOPIAN TUBE WAS ENGORGED AND THICKENED AT THE CORNUAL REGION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DYSMENORRHEA, DYSPAREUNIA, LEFT LOWER QUADRANT PAIN, HYPERMENORRHEA, TRUNCAL OBESITY, PELVIC ADHESIONS AND NABOTHIAN CYST. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MIGRAINE ("MIGRAINES/HEADACHES"), IRON DEFICIENCY ANAEMIA ("ANEMIA"), PELVIC PAIN ("WORSENING PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), AUTOIMMUNE DISORDER ("AUTOIMUNE SYMPTOMS") AND HYPERSENSITIVITY ("HYPERSENSITIVITY "). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD UNDERGONE ESSURE REMOVAL SURGERY AND HYSTEROSCOPY, D&C, LAPAROSCOPY, B-S). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, UTERINE PERFORATION, SALPINGITIS, MIGRAINE, IRON DEFICIENCY ANAEMIA, PELVIC PAIN, GENITAL HAEMORRHAGE, AUTOIMMUNE DISORDER AND HYPERSENSITIVITY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED AUTOIMMUNE DISORDER, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, IRON DEFICIENCY ANAEMIA, MIGRAINE, PELVIC PAIN, SALPINGITIS AND UTERINE PERFORATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE ALSO ENDED UP NEEDING WOUND CARE WITH DRAINAGE AFTER HER ESSURE REMOVAL SURGERY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2018: STATUS POST A SHORT OCCLUSION DEVICE ON THE RIGHT. OCCLUSION OF THE RIGHT FALLOPIAN TUBE WAS IDENTIFIED. 2. GOOD CONTRAST OPACIFICATION OF THE LEFT FALLOPIAN TUBE, WITH NO FREE SPILL CONTRAST OBSERVED FROM THE LEFT, WHICH MAY REPRESENT LEFT FALLOPIAN TUBE OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: UTERINE PERFORATION, SALPINGITIS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-JUL-2021: MR RECEIVED. REPORTER INFORMATION , PATIENT DETAILS , OTHER RELEVANT HISTORY , LAB DATA , DATE EXPLANTED , EVENT : " THE RIGHT FALLOPIAN TUBE WAS ENGORGED AND THICKENED AT THE CORNUAL REGION " ADDED. EVENT " " PERFORATION UPDATED TO " PERFORATION OF THE ESSURE DEVICE THROUGH THE UTERUS". 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 · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION') AND PERFORATION ('PERFORATION') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MIGRAINE ("MIGRAINES/ HEADACHES"), IRON DEFICIENCY ANAEMIA ("ANEMIA"), PELVIC PAIN ("WORSENING PAIN"), GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING"), AUTOIMMUNE DISORDER ("AUTOIMMUNE SYMPTOMS") AND HYPERSENSITIVITY ("HYPERSENSITIVITY "). THE PATIENT WAS TREATED WITH SURGERY (SHE HAD UNDERGONE ESSURE REMOVAL SURGERY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE PERFORATION, MIGRAINE, IRON DEFICIENCY ANAEMIA, PELVIC PAIN, GENITAL HAEMORRHAGE, AUTOIMMUNE DISORDER AND HYPERSENSITIVITY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED AUTOIMMUNE DISORDER, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, HYPERSENSITIVITY, IRON DEFICIENCY ANAEMIA, MIGRAINE, PELVIC PAIN AND PERFORATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: SHE ALSO ENDED UP NEEDING WOUND CARE WITH DRAINAGE AFTER HER ESSURE REMOVAL SURGERY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. 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
    976491 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R