BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10188920 · Received June 24, 2020

    Report

    Report Number
    2951250-2020-09389
    Event Type
    Injury
    Date Received
    June 24, 2020
    Date of Event
    January 29, 2019
    Report Date
    July 31, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 ('REMOVAL'). IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 823482,621688) INSERTED. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED: CYST, MENORRHAGIA, PELVIC PAIN, UTERINE FIBROID AND OVARIAN CYST. ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2019, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 11 YEARS 9 MONTHS AFTER INSERTION OF ESSURE (ESS205). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY, REMOVAL OF RIGHT PARATUBAL CYST). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: DISCREPANCY NOTED, INSERTION DETAILS: (B)(6) 2007. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020, MEDICAL RECORDS RECEIVED: NEW REPORTER INFORMATION ADDED, LOT NUMBER ADDED, PATIENT DEMOGRAPHIC DETAILS ADDED, ESSURE PRODUCT CODE UPDATED. 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('REMOVAL') IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 823482-NOT VALID,621688) INSERTED. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED CYST, MENORRHAGIA, PELVIC PAIN, UTERINE FIBROID AND OVARIAN CYST. ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2019, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 11 YEARS 9 MONTHS AFTER INSERTION OF ESSURE (ESS205). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY, REMOVAL OF RIGHT PARATUBAL CYST). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: DISCREPANCY NOTED INSERTION DETAILS (B)(6) 2007 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 29-JUL-2020: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('REMOVAL') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON (B)(6) 2007, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2019, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-JUL-2020: 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('REMOVAL') IN A 46-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 823482-INV,621688) INSERTED. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED CYST, MENORRHAGIA, PELVIC PAIN, UTERINE FIBROID AND OVARIAN CYST. ON (B)(6)2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6)2019, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 11 YEARS 9 MONTHS AFTER INSERTION OF ESSURE (ESS205). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY, REMOVAL OF RIGHT PARATUBAL CYST). ESSURE (ESS205) WAS REMOVED ON (B)(6)2019. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: DISCREPANCY NOTED INSERTION DETAILS (B)(6)2007. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-JUL-2020: UPDATE OF INFORMATION (BATCH IS INVALID). 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('REMOVAL') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON (B)(6) 2007, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2019, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655113 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS205 823482-NOT VALID,621688 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other| R