BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 11133650 · Received January 7, 2021

    Report

    Report Number
    2951250-2021-00092
    Event Type
    Injury
    Date Received
    January 7, 2021
    Date of Event
    December 4, 2015
    Report Date
    January 11, 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 MEDICAL DEVICE REMOVAL ('MEDICAL DEVICE REMOVAL') IN A 48-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 860762-INV) INSERTED. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERPLASIA, ADENOCARCINOMA, CHRONIC CERVICITIS, OVARIAN ADHESION, GRAVIDA II, PARITY 2, MORBID OBESITY, ATYPICAL HYPERPLASIA OF ENDOMETRIUM, ENTEROCELE, LYMPHADENECTOMY, OMENTECTOMY AND CYTOLOGY NOS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 4 YEARS AFTER INSERTION OF ESSURE. THE PATIENT WAS TREATED WITH SURGERY (MODIFIED RADICAL HYSTERECTOMY WITH BILATERAL SALPINGOOOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: LEFT TUBAL OSTIUM : 3-4 COILS IN THE UTERINE CAVITY AFTER DEPLOYMENT. THE RIGHT TUBAL OSTIUM : THERE WERE 3-4 COILS IN THE UTERINE CAVITY POST DEPLOYMENT. LOT NUMBER REPORTED 860762 IS INV. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-JAN-2021: UPDATE OF INFORMATION (BATCH IS NOT VALID). 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 MEDICAL DEVICE REMOVAL ('MEDICAL DEVICE REMOVAL') IN A 48-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 860762-INV) INSERTED. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERPLASIA, ADENOCARCINOMA, CHRONIC CERVICITIS, OVARIAN ADHESION, GRAVIDA II, PARITY 2, MORBID OBESITY, ATYPICAL HYPERPLASIA OF ENDOMETRIUM, ENTEROCELE, LYMPHADENECTOMY, OMENTECTOMY AND CYTOLOGY NOS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 4 YEARS AFTER INSERTION OF ESSURE. THE PATIENT WAS TREATED WITH SURGERY (MODIFIED RADICAL HYSTERECTOMY WITH BILATERAL SALPINGOOOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: LEFT TUBAL OSTIUM : 3-4 COILS IN THE UTERINE CAVITY AFTER DEPLOYMENT. THE RIGHT TUBAL OSTIUM : THERE WERE 3-4 COILS IN THE UTERINE CAVITY POST DEPLOYMENT. LOT NUMBER REPORTED 860762 IS INV. LOT# 860762 REPORTED IS INV. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-JAN-2021: 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 · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('MEDICAL DEVICE REMOVAL') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 860762) INSERTED. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERPLASIA, ADENOCARCINOMA, CHRONIC CERVICITIS, OVARIAN ADHESION, MULTIGRAVIDA, PARITY 2, MORBID OBESITY, ATYPICAL HYPERPLASIA OF ENDOMETRIUM, ENTEROCELE, LYMPHADENECTOMY, OMENTECTOMY AND CYTOLOGY. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 4 YEARS AFTER INSERTION OF ESSURE. THE PATIENT WAS TREATED WITH SURGERY (MODIFIED RADICAL HYSTERECTOMY WITH BILATERAL SALPINGOOOPHORECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: LEFT TUBAL OSTIUM : 3-4 COILS IN THE UTERINE CAVITY AFTER DEPLOYMENT. THE RIGHT TUBAL OSTIUM : THERE WERE 3-4 COILS IN THE UTERINE CAVITY POST DEPLOYMENT. WE RECEIVED A LOT NUMBER IN THIS CASE. 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
    30976 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 860762-INV 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other| R