BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 7964567 · Received October 15, 2018

    Report

    Report Number
    2951250-2018-04298
    Event Type
    Malfunction
    Date Received
    October 15, 2018
    Date of Event
    September 26, 2018
    Report Date
    November 5, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SPONTANEOUS CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("FRACTURE OF RIGHT PROMIXAL END OF THE ESSURE INSERT") AND GENITAL HAEMORRHAGE ("IRREGULAR BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852005) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2018, 7 YEARS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH PELVIC PAIN AND UTERINE LEIOMYOMA ("4CM FIBROID"). AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, GENITAL HAEMORRHAGE AND UTERINE LEIOMYOMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE BREAKAGE, GENITAL HAEMORRHAGE AND UTERINE LEIOMYOMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: REPORTED AS 4CM FIBROID AND POLIS TOO. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM: ON (B)(6) 2012: FRACTURE OF THE RIGHT PROXIMAL END OF THE ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 23-OCT-2018: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLIANT. ON 23-OCT-2018: NO NEW INFORMATION ADDED. ON 23-OCT-2018: NO NEW INFORMATION ADDED. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    SPONTANEOUS CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("FRACTURE OF RIGHT PROMIXAL END OF THE ESSURE INSERT") AND GENITAL HAEMORRHAGE ("IRREGULAR BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852005) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2018, 7 YEARS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH PELVIC PAIN AND UTERINE LEIOMYOMA ("4CM FIBROID"). AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, GENITAL HAEMORRHAGE AND UTERINE LEIOMYOMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE BREAKAGE, GENITAL HAEMORRHAGE AND UTERINE LEIOMYOMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: REPORTED AS 4CM FIBROID AND POLIS TOO. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: FRACTURE OF THE RIGHT PROXIMAL END OF THE ESSURE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-OCT-2018: NEW EVENT '4CM FIBROID' WAS ADDED. LOT NUMBER WAS ADDED. NON SIGNIFICANT CORRECTION WAS PERFORMED. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    "NTANEOUS" CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("FRACTURE OF RIGHT PROMIXAL END OF THE ESSURE INSERT") AND GENITAL HAEMORRHAGE ("IRREGULAR BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852005) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2018, 7 YEARS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) WITH PELVIC PAIN AND UTERINE LEIOMYOMA ("4CM FIBROID"). AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, GENITAL HAEMORRHAGE AND UTERINE LEIOMYOMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE BREAKAGE, GENITAL HAEMORRHAGE AND UTERINE LEIOMYOMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: REPORTED AS 4CM FIBROID AND POLIS TOO. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: FRACTURE OF THE RIGHT PROXIMAL END OF THE ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-OCT-2018: NEW EVENT '4CM FIBROID' WAS ADDED. LOT NUMBER WAS ADDED. NON SIGNIFICANT CORRECTION WAS PERFORMED. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805524 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 852005 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other