BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3961607 · Received June 16, 2014

    Report

    Report Number
    2951250-2014-00276
    Event Type
    Injury
    Date Received
    June 16, 2014
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP INFO RECEIVED ON 18-JUN-2014: THE PTC GLOBAL NUMBER WAS ADDED AS (B)(4). PTC INVESTIGATION RESULT WAS RECEIVED ON 03-JUL-2014. THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). (B)(4). FINAL ASSESSMENT: SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE COULD INSPECT THE MICRO-INSERT TO CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR AND INSPECT THE DEVICE TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. 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 AT THIS TIME. MEDICAL ASSESSMENT: THE REPORTED MEDICAL EVENT IS A POSSIBLE UNDESIRABLE EVENT WITH THE USE OF ESSURE AND IS NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. NO BATCH NUMBER WAS REPORTED. NEITHER A TECHNICAL BATCH INVESTIGATION NOR A BATCH CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVAL IS POSSIBLE WITHOUT A BATCH NUMBER. AT THE TIME OF THIS MEDICAL ASSESSMENT THE TECHNICAL INVESTIGATION CONCLUDED "UNCONFIRMED QUALITY DEFECT". BASED ON THE INFO AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT, REFERS TO A FEMALE CONSUMER WHICH HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND IMPLANTS MIGRATED AND PUNCTURED THE UTERUS. THE REPORTER CONSIDERED THE EVENT AS RELATED TO ESSURE. IMPLANTS MIGRATED AND PUNCTURED THE UTERUS WAS CONSIDERED SERIOUS AS MEDICALLY SIGNIFICANT AND IS LISTED ACCORDING TO REFERENCE SAFETY INFO FOR ESSURE. THIS EVENT WAS REGARDED AS AN INCIDENT SINCE A SURGICAL INTERVENTION WAS PERFORMED (HYSTERECTOMY). DURING ESSURE MICRO-INSERT THERAPY THERE IS A RISK THAT THE DEVICE COULD MOVE OUT OF FALLOPIAN TUBES, THIS MOVEMENT COULD BE AN EXPULSION (INTO UTERUS OR OUT OF THE BODY) OR MIGRATION (DISTAL FALLOPIAN TUBE OR PERITONEAL CAVITY). IN THIS PARTICULAR CASE, THE CONSUMER STATED THAT AN X-RAY IDENTIFIED THAT IMPLANTS MIGRATED AND PUNCTURED HER UTERUS. THE EXACT DATE AND THE MECHANISM OF THIS EVENT ARE NOT KNOWN, HOWEVER CONSIDERING ITS NATURE, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. A PRODUCT MECHANICAL COMPLAINT ANALYSIS WAS PERFORMED AND CONCLUDED THAT BASED ON THE INFO AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT.

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT: RECEIVED FROM A CONSUMER IS PHYSICIAN (CASE # MW5036017) IN THE UNITED STATES ON 16-JUN-2014 WHICH REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE INSERTED ON (B)(6) 2011 AND EXPERIENCED THE FOLLOWING ADVERSE EVENTS. AN X-RAY WAS PERFORMED AND SHOWED THAT IMPLANTS MIGRATED AND PUNCTURED HER UTERUS. IN 2014, ESSURE WAS REMOVED WHICH HER UTERUS (FULL HYSTERECTOMY PERFORMED). NO FURTHER INFO WAS PROVIDED. OTHER SERIOUS MEDICAL EVENT WAS ASSESSED BY CONSUMER; HOWEVER, NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353261 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other