BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 11835031 · Received May 17, 2021

    Report

    Report Number
    2951250-2021-02268
    Event Type
    Injury
    Date Received
    May 17, 2021
    Report Date
    June 1, 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 EMBEDDED DEVICE ('R ESSURE DEVICE LIKELY EMBEDDED IN MYOMETRIUM AND WAS NOT SEEN INTRAOPERATIVELY IN THE TUBE') AND ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY DIAGNOSED AFTER PROCEDURE (AND BEFORE POST-HSG DONE) / POSSIBLE ECTOPIC') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A36523) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PAIN ("PAIN"), HAEMORRHAGE ("ABNORMAL BLEEDING") AND PSYCHOLOGICAL TRAUMA ("PSCYH INJURY") AND WAS FOUND TO HAVE AN ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY LAPAROSCOPIC (BILATERAL) AND DILATION AND CURETTAGE). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, PAIN, HAEMORRHAGE AND PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE REPORTER CONSIDERED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, EMBEDDED DEVICE, HAEMORRHAGE, PAIN AND PSYCHOLOGICAL TRAUMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY IN ESSURE INSERTION DATE, PREVIOUSLY REPORTED AS (B)(6) 2013 AND NOW REPORETED AS (B)(6) 2013. DISCREPANCY IN ESSURE INSERTION DATE - (B)(6) 2013 AS PER MR COMPLETE COILS PROTRUDING INTO UTERINE CAVITY: RIGHT = 4, LEFT= 2 PATIENT EXPERIENCED ANOTHER PREGNANCY EPISODE IN(B)(6) 2017WHICH CAPTURED UNDER CASE 2021-142567 DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2015: RIGHT ESSURE MICRO INSERT SHOWS UNSATISFACTORY RESULT, WITH PATENCY OF THE RIGHT FALLOPIAN TUBE AND FREE SPILLAGE OF CONTRAST. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-JUN-2021: 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.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ('R ESSURE DEVICE LIKELY EMBEDDED IN MYOMETRIUM AND WAS NOT SEEN INTRAOPERATIVELY IN THE TUBE') AND ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY DIAGNOSED AFTER PROCEDURE (AND BEFORE POST-HSG DONE) / POSSIBLE ECTOPIC') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A36523) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PAIN ("PAIN"), HAEMORRHAGE ("ABNORMAL BLEEDING") AND PSYCHOLOGICAL TRAUMA ("PSCYH INJURY") AND WAS FOUND TO HAVE AN ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY LAPAROSCOPIC (BILATERAL) AND DILATION AND CURETTAGE). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, PAIN, HAEMORRHAGE AND PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE REPORTER CONSIDERED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, EMBEDDED DEVICE, HAEMORRHAGE, PAIN AND PSYCHOLOGICAL TRAUMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY IN ESSURE INSERTION DATE, PREVIOUSLY REPORTED AS (B)(6) 2013 AND NOW REPORETED AS (B)(6) 2013. DISCREPANCY IN ESSURE INSERTION DATE - (B)(6) 2013 AS PER MR COMPLETE COILS PROTRUDING INTO UTERINE CAVITY: RIGHT = 4, LEFT= 2. PATIENT EXPERIENCED ANOTHER PREGNANCY EPISODE IN MAR 2017WHICH CAPTURED UNDER CASE 2021-142567 DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2015: RIGHT ESSURE MICRO INSERT SHOWS UNSATISFACTORY RESULT, WITH PATENCY OF THE RIGHT FALLOPIAN TUBE AND FREE SPILLAGE OF CONTRAST. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-APR-2021: MR RECEIVED. NEW EVENT "R ESSURE DEVICE LIKELY EMBEDDED IN MYOMETRIUM AND WAS NOT SEEN INTRAOPERATIVELY IN THE TUBE" AND "PREGNANCY DIAGNOSED AFTER PROCEDURE (AND BEFORE POST-HSG DONE)" WAS ADDED. CASE BECAME SERIOUS INCIDENT. ESSURE REMOVAL DETAILS, LAB DATA, LOT NUMBER, EXPIRATION DATE, RCC ,PATIENT¿S DATE OF BIRTH AND REPORTER INFORMATION WAS ADDED. 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
    734276 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 A36523 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R