BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7595215 · Received June 13, 2018

    Report

    Report Number
    2951250-2018-02595
    Event Type
    Injury
    Date Received
    June 13, 2018
    Report Date
    August 14, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE") AND DEVICE EXPULSION ("EXPULSION OF ESSURE DEVICE") IN A 35-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893029) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIPAROUS. CONCURRENT CONDITIONS INCLUDED OVARIAN CYST. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 4 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("HEAVY VAGINAL BLEEDING/ABNORMAL BLEEDING (VAGINAL MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL MENORRHAGIA)"). ON (B)(6) 2012, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN/PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND ALLERGY TO METALS ("NICKEL ALLERGY"). THE PATIENT WAS TREATED WITH SURGERY AND SURGERY. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DEVICE EXPULSION, VAGINAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA AND ALLERGY TO METALS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, DEVICE DISLOCATION, DEVICE EXPULSION, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: UNABLE TO PLACE MICRO-INSERT IN LEFT TUBAL OSTIA. PLACEMENT OF ONE ESSURE MICRO-INSERT ONLY. DIAGNOSTIC RESULTS: ON (B)(6) 2013, RIGHT AND LEFT OVARIES WERE NORMAL. FOLLICULAR CYST NOTED ON THE RIGHT OVARY. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-AUG-2018: QUALITY SAFETY EVALUATION OF PTC 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

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE") AND DEVICE EXPULSION ("EXPULSION OF ESSURE DEVICE") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893029) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIPAROUS. CONCURRENT CONDITIONS INCLUDED OVARIAN CYST. CONCOMITANT PRODUCTS INCLUDED IBUPROFEN. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 4 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("HEAVY VAGINAL BLEEDING/ABNORMAL BLEEDING (VAGINAL MENORRHAGIA)") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL MENORRHAGIA)"). ON (B)(6) 2012, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN/PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND ALLERGY TO METALS ("NICKEL ALLERGY"). THE PATIENT WAS TREATED WITH SURGERY AND SURGERY. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DEVICE EXPULSION, VAGINAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, MENORRHAGIA AND ALLERGY TO METALS OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALLERGY TO METALS, DEVICE DISLOCATION, DEVICE EXPULSION, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: UNABLE TO PLACE MICRO-INSERT IN LEFT TUBAL OSTIA. PLACEMENT OF ONE ESSURE MICRO-INSERT ONLY. DIAGNOSTIC RESULTS: ON (B)(6) 2013, RIGHT AND LEFT OVARIES WERE NORMAL. FOLLICULAR CYST NOTED ON THE RIGHT OVARY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-APR-2018: FUP 1 AND FUP 2 PROCESSED TOGETHER. PFS RECEIVED. NEW EVENTS ADDED- ABNORMAL BLEEDING (VAGINAL MENORRHAGIA), EXPULSION OF ESSURE DEVICE, MIGRATION OF ESSURE DEVICE, NICKEL ALLERGY, PAIN, DID NOT UNDERGO ESSURE CONFIRMATION TEST. ON 4-APR-2018: FUP 1 AND FUP 2 PROCESSED TOGETHER. MR RECEIVED. 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
    437494 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 893029

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other| R IBUPROFEN| IBUPROFEN| IBUPROFEN