BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 16476852 · Received March 3, 2023

    Report

    Report Number
    2951250-2023-00812
    Event Type
    Injury
    Date Received
    March 3, 2023
    Date of Event
    July 20, 2012
    Report Date
    September 28, 2023
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 32 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 547 DAYS AFTER ESSURE INSERTION, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: MORE THAN ONE RELATED SURGERY. 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: 23-MAR-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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 32 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF ABNORMAL UTERINE BLEEDING, URINARY INCONTINENCE, PELVIC PAIN FEMALE, MENSES PAINFUL, BACK PAIN, RASH (ALLERGY-PENICILLIN-RASH-ALLERGY), ELECTIVE ABORTION, PARITY 3 AND MULTIGRAVIDA. THE PATIENT HAD A FAMILY HISTORY OF ASTHMA (MOTHER) AND CROHN'S DISEASE (HUSBAND). ON (B)(6), 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6), 2012, 566 DAYS AFTER ESSURE INSERTION, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY - UTERUS & BILATERAL SALPINGECTOMIES). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: MORE THAN ONE RELATED SURGERY-N. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [HYSTEROSALPINGOGRAM] ON (B)(6), 2012: GOOD POSITION OF ESSURE DEVICES WITH NO EVIDENCE FOR SPILLAGE OF CONTRAST [PATHOLOGY TEST] ON (B)(6), 2021: SURGICAL PATHOLOGY REPORT: CLINICAL HISTORY: ABNORMAL UTERINE BLEEDING, PELVIC PAIN AND DYSMENORRHEA MICROSCOPIC DIAGNOSIS A. UTERUS, CERVIZ & BILATERAL FALLOPIAN TUBES UTERUS, CERVIX, AND BILATERAL FALLOPIAN TUBES, LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGECTOMY : CERVIX: MILD CHRONIC ECTO ¿ENDOCERVICITIS WITH FOCAL SQUAMOUS METAPLASIA. NABOTHIAN CYSTS. NEGATIVE FOR DYSPLASIA OR MALIGNANCY. ENDOMETRIUM: SECRETORY ENDOMETRIUM. MYOMETRIUM : ADENOMYOSIS. FALLOPIAN TUBES: RIGHT: FALLOPIAN TUBE WITH NO SIGNIFICANT HISTOPATHOLOGY. PARATUBAL CYSTS. LEFT: FALLOPIAN TUBE WITH NO SIGNIFICANT HISTOPATHOLOGY B. ENDOMETRIOSIS POSTERIOR CUL DE SAC ENDOMETRIOSIS, POSTERIOR CUL-DE-SAC, EXCISION: BENIGN FIBROADIPOSE AND VASCULAR TISSUE WITH FOCI OF ENDOMETRIOSIS GROSS DESCRIPTION: A. UTERUS, CERVIZ & BILATERAL FALLOPIAN TUBES THE RIGHT FALLOPIAN TUBE, INCLUDING FIMBRIA, MEASURES 7.2 CM IN LENGTH BY UP TO 0.7 CM IN DIAMETER. THE LEFT FALLOPIAN TUBE, INCLUDING FIMBRIA, MEASURES 6.5 CM IN LENGTH BY UP TO 0.6 CM IN DIAMETER. THE UTERUS AND CERVIX WEIGH 169 GRAMS. UPON OPENING THE ENDOCERVICAL CANAL MEASURES UP TO 3 CM. THE REMAINDER OF THE ENDOMETRIAL CAVITY MEASURES UP TO 5 CM. THERE IS A SMALL AMOUNT OF PINK/TAN ENDOMETRIUM MEASURING UP TO 0.3 CM IN GREATEST THICKNESS. THE MYOMETRIUM MEASURES UP TO 2.2 CM IN GREATEST THICKNESS. UPON REMOVAL OF THE BILATERAL ADNEXA THERE ARE METAL WIRE ESSURE COILS PRESENT. B. ENDOMETRIOSIS POSTERIOR CUL DE SAC: IT CONSISTS OF A SINGLE PIECE OF GRAY/TAN MEMBRANOUS TISSUE MEASURING 0.8 X 0.2 X 0.2 CM IN GREATEST DIMENSION 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: (B)(6), 2023: MEDICAL RECORD RECEIVED. SURGICAL PATHOLOGY REPORT ADDED. MEDICAL HISTORY, REPORTER INFORMATION UPDATED. LAB DAT ADDED. 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 AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 32 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 547 DAYS AFTER ESSURE INSERTION, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: MORE THAN ONE RELATED SURGERY-N. 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 WILL BE 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
    2022443 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Required Intervention