BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6266801 · Received January 20, 2017

    Report

    Report Number
    2951250-2017-00215
    Event Type
    Injury
    Date Received
    January 20, 2017
    Report Date
    February 17, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY-SAFETY EVALUATION OF PTC: SAMPLE IS NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 30-JAN-2017: QUALITY-SAFETY EVALUATION WAS RECEIVED. COMPANY CAUSALITY COMMENT: A FEMALE PLAINTIFF HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND IT WAS REPORTED THAT DEVICE IN THE RIGHT TUBE HAD MIGRATED OUT OF THE TUBE. A LAPAROSCOPIC RIGHT SALPINGO-OOPHORECTOMY WAS PERFORMED AND THE PHYSICIAN ATTEMPTED TO REMOVE THE ESSURE COIL. THE COIL WAS EMBEDDED IN THE RIGHT POSTERIOR CUL-DE-SAC. THIS EVENT, SEEN AS DEVICE DISLOCATION INTO ABDOMINAL CAVITY, IS REGARDED AS ANTICIPATED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. ALTHOUGH NOT REPORTED AS SUCH, THE MOST LIKELY MECHANISM FOR THE COIL TO BE EMBEDDED IN THE RIGHT POSTERIOR CUL-DE-SAC, WOULD BE THROUGH A UTERINE/FALLOPIAN TUBE PERFORATION. UTERINE/FALLOPIAN TUBE PERFORATION MAY OCCUR WITH TRANS-CERVICAL INTRAUTERINE PROCEDURE (E.G. HYSTEROSCOPY, CURETTAGE). UTERINE PERFORATION WITH ESSURE MAY OCCUR, MOST OFTEN DURING INSERTION. IN THIS CASE, THE EXACT DATE AND MECHANISM OF DEVICE DISLOCATION INTO ABDOMINAL CAVITY WAS NOT KNOWN. HOWEVER, BASED ON ITS NATURE, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT BECAUSE SURGICAL INTERVENTION WAS PERFORMED (IT WAS NOT CLEAR WHETHER ESSURE COILS WERE REMOVED). ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("DEVICE IN THE RIGHT TUBE HAD MIGRATED OUT OF THE TUBE / COIL WAS EMBEDDED IN THE RIGHT POSTERIOR CUL-DE-SAC") IN A FEMALE PATIENT WHO RECEIVED ESSURE FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT STARTED ESSURE. ON (B)(6) 2013, 126 DAYS AFTER STARTING ESSURE, THE PATIENT EXPERIENCED DEVICE DIFFICULT TO USE ("ATTEMPTED REMOVAL OF THE ESSURE"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED), PELVIC PAIN ("CHRONIC PELVIC PAIN AFTER ESSURE REMOVAL ATTEMPT / SHARP RIGHT-SIDED PAIN"), WEIGHT INCREASED ("WEIGHT GAIN AFTER ESSURE REMOVAL ATTEMPT") AND MENORRHAGIA ("ABNORMAL AND HEAVY BLEEDING DURING MENSTRUATION AFTER ESSURE REMOVAL ATTEMPT"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC RIGHT SALPINGO-OOPHORECTOMY). AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DEVICE DIFFICULT TO USE, PELVIC PAIN, WEIGHT INCREASED AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, DEVICE DIFFICULT TO USE, PELVIC PAIN, WEIGHT INCREASED AND MENORRHAGIA TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ON (B)(6) 2015: HYSTEROSALPINGOGRAM RESULT WAS CONFIRMED SATISFACTORY PLACEMENT OF THE LEFT COIL. (B)(6) 2015: THE HSG TEST REVEALED THAT THE DEVICE IN THE RIGHT TUBE HAD MIGRATED OUT OF THE TUBE. COMPANY CAUSALITY COMMENT: A FEMALE PLAINTIFF HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND IT WAS REPORTED THAT DEVICE IN THE RIGHT TUBE HAD MIGRATED OUT OF THE TUBE. A LAPAROSCOPIC RIGHT SALPINGO-OOPHORECTOMY WAS PERFORMED AND THE PHYSICIAN ATTEMPTED TO REMOVE THE ESSURE COIL. THE COIL WAS EMBEDDED IN THE RIGHT POSTERIOR CUL-DE-SAC. THIS EVENT, SEEN AS DEVICE DISLOCATION INTO ABDOMINAL CAVITY, IS REGARDED AS ANTICIPATED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. ALTHOUGH NOT REPORTED AS SUCH, THE MOST LIKELY MECHANISM FOR THE COIL TO BE EMBEDDED IN THE RIGHT POSTERIOR CUL-DE-SAC, WOULD BE THROUGH A UTERINE/FALLOPIAN TUBE PERFORATION. UTERINE/FALLOPIAN TUBE PERFORATION MAY OCCUR WITH TRANS-CERVICAL INTRAUTERINE PROCEDURE (E.G. HYSTEROSCOPY, CURETTAGE). UTERINE PERFORATION WITH ESSURE MAY OCCUR, MOST OFTEN DURING INSERTION. IN THIS CASE, THE EXACT DATE AND MECHANISM OF DEVICE DISLOCATION INTO ABDOMINAL CAVITY WAS NOT KNOWN. HOWEVER, BASED ON ITS NATURE, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT BECAUSE SURGICAL INTERVENTION WAS PERFORMED (IT WAS NOT CLEAR WHETHER ESSURE COILS WERE REMOVED). ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. A PRODUCT TECHNICAL ANALYSIS IS BEING SOUGHT. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50390 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R