BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 18168985 · Received November 20, 2023

    Report

    Report Number
    2951250-2023-03354
    Event Type
    Injury
    Date Received
    November 20, 2023
    Report Date
    December 18, 2023
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("LEFT TUBE AND THERE APPEARS TO BE IN THE ESSURE DEVICE IN THE UTERINE CAVITY") IN A 39 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF LEFT LOWER QUADRANT PAIN AND PELVIC PAIN IN 2016 AND PARITY 2 (HAVING 2 CHILDREN.), GRAVIDA II AND OVERWEIGHT. ESSURE WAS REMOVED ON (B)(6) 2016. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE SHE EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTEROCTOMY,BILATERAL SALPINGECTOMY,CYSTECTOMY). THE REPORTER CONSIDERED DEVICE DISLOCATION TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: ESSURE PROCEDURE PERFORMED ON 18DEC 0 COILS PRESENT ON THE RIGHT SIDE AND 7 ON THE LEFT SIDE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX: 26.776 KG/SQM. [PATHOLOGY TEST] ON (B)(6) 2016: FINAL DIAGNOSIS: PART 1: ENDOMETRIUM, CURETTINGS: A. ENDOMETRIAL POLYP. B. SECRETORY ENDOMETRIUM. PART 2: ESSURE COIL, REMOVAL ESSURE- COIL (GROSS DIAGNOSIS ONLY). PART 3: FALLOPIAN TUBE, LEFT, RESECTED PORTION: FALLOPIAN TUBE, COMPLETE CROSS SECTION. PART 4: FALLOPIAN TUBE, RIGHT, RESECTED PORTION: FALLOPIAN TUBE, COMPLETE CROSS SECTION. PART 5: OVARY, RIGHT, CYST WALL, EXCISION: A. CORPUS LUTEAL CYST WALL. B. BLOOD. GJC/ACS, ACS/ACS. COMMENT: PART 2: THE SPECIMEN LABELED "ESSURE COILS" HAS BEEN SUBJECTED TO A GROSS EXAMINATION ONLY. IF IT IS DESIRED THAT THIS SPECIMEN BE PROCESSED FOR ADDITIONAL STUDIES, IT IS SUGGESTED THAT THE CASE PATHOLOGIST BE NOTIFIED WITHIN TWO WEEKS OF THE SIGN OUT DATE OF THIS REPORT. THIS IS PARTICULARLY IMPORTANT AS SPECIMENS ARE ROUTINELY DISCARDED AFTER A PRESCRIBED PERIOD OF TIME. GROSS DESCRIPTION: PART 2 LABELED WITH THE "ESSURE COILS". THE SPECIMEN CONSISTS OF 2 UNDESIGNATED PORTIONS OF GREY METALLIC THREAD WITH ATTACHED METALLIC COILS. THE THREAD PORTIONS ARE EACH 3.0 CM LONG. ONE PORTION OF COILS IS 0.5 CM LONG AND THE OTHER PORTION OF COILS IS 3.2 CM LONG. [ULTRASOUND PELVIS] ON (B)(6) 2016: CLINICAL INDICATIONS HISTORY OF PELVIC PAIN. HISTORY OF ESSURE. SCANNING TECHNIQUE: TRANSVAGINAL. UTERUS- THE PATIENT HAS A HISTORY OF ESSURES. A RIGHT ESSURE IS VISUALIZED AND IS IN THE EXPECTED ANATOMICAL LOCATION. HOWEVER, THERE IS NO ESSURE IN THE LEFT CORNEAL REGION OR FALLOPIAN TUBE. THERE IS AN ESSURE WITHIN THE UTERINE CAVITY. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 15-DEC-2023: 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 · 0

    THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("LEFT TUBE AND THERE APPEARS TO BE IN THE ESSURE DEVICE IN THE UTERINE CAVITY") IN A 39 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF LEFT LOWER QUADRANT PAIN AND PELVIC PAIN IN 2016 AND PARITY 2 (HAVING 2 CHILDREN.), GRAVIDA II AND OVERWEIGHT. ESSURE WAS REMOVED ON (B)(6) 2016. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE SHE EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTEROCTOMY,BILATERAL SALPINGECTOMY,CYSTECTOMY). THE REPORTER CONSIDERED DEVICE DISLOCATION TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: ESSURE PROCEDURE PERFORMED ON (B)(6) 0 COILS PRESENT ON THE RIGHT SIDE AND 7 ON THE LEFT SIDE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX: 26.776 KG/SQM. [PATHOLOGY TEST] ON (B)(6) 2016: FINAL DIAGNOSIS: PART 1: ENDOMETRIUM, CURETTINGS: A. ENDOMETRIAL POLYP. B. SECRETORY ENDOMETRIUM. PART 2: ESSURE COIL, REMOVAL ESSURE- COIL (GROSS DIAGNOSIS ONLY). PART 3: FALLOPIAN TUBE, LEFT, RESECTED PORTION: FALLOPIAN TUBE, COMPLETE CROSS SECTION. PART 4: FALLOPIAN TUBE, RIGHT, RESECTED PORTION: FALLOPIAN TUBE, COMPLETE CROSS SECTION. PART 5: OVARY, RIGHT, CYST WALL, EXCISION: A. CORPUS LUTEAL CYST WALL. B. BLOOD. GJC/ACS ACS/ACS COMMENT: PART 2: THE SPECIMEN LABELED "ESSURE COILS" HAS BEEN SUBJECTED TO A GROSS EXAMINATION ONLY. IF IT IS DESIRED THAT THIS SPECIMEN BE PROCESSED FOR ADDITIONAL STUDIES, IT IS SUGGESTED THAT THE CASE PATHOLOGIST BE NOTIFIED WITHIN TWO WEEKS OF THE SIGN OUT DATE OF THIS REPORT. THIS IS PARTICULARLY IMPORTANT AS SPECIMENS ARE ROUTINELY DISCARDED AFTER A PRESCRIBED PERIOD OF TIME. GROSS DESCRIPTION: PART 2 LABELED WITH THE "ESSURE COILS". THE SPECIMEN CONSISTS OF 2 UNDESIGNATED PORTIONS OF GREY METALLIC THREAD WITH ATTACHED METALLIC COILS. THE THREAD PORTIONS ARE EACH 3.0 CM LONG. ONE PORTION OF COILS IS 0.5 CM LONG AND THE OTHER PORTION OF COILS IS 3.2 CM LONG. [ULTRASOUND PELVIS] ON (B)(6) 2016: CLINICAL INDICATIONS HISTORY OF PELVIC PAIN HISTORY OF ESSURE SCANNING TECHNIQUE: TRANSVAGINAL UTERUS- THE PATIENT HAS A HISTORY OF ESSURES. A RIGHT ESSURE IS VISUALIZED AND IS IN THE EXPECTED ANATOMICAL LOCATION. HOWEVER, THERE IS NO ESSURE IN THE LEFT CORNEAL REGION OR FALLOPIAN TUBE. THERE IS AN ESSURE WITHIN THE UTERINE CAVITY. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE 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
    2088933 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention