BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4192877 · Received October 22, 2014

    Report

    Report Number
    2951250-2014-00455
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 24, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FOLLOW UP INFORMATION RECEIVED ON 26-MAR-2015: THE REQUIRED NUMBER OF FOLLOW-UP ATTEMPTS HAVE BEEN COMPLETED, WITH NO RESPONSE TO DATE. CASE CONSIDERED CLOSED. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND IT WENT THROUGH THE UTERINE WALL. THIS CASE IS NOT MEDICALLY CONFIRMED. THIS EVENT WAS CONSIDERED SERIOUS DUE TO MEDICAL IMPORTANCE AND LISTED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. UTERINE/FALLOPIAN TUBE PERFORATION MAY OCCUR WITH TRANS-CERVICAL INTRAUTERINE PROCEDURE (E.G. HYSTEROSCOPY, CURETTAGE). IN THIS CASE IT WAS REPORTED THAT THE UTERINE PERFORATION OCCURRED DURING ESSURE INSERTION. GIVEN THE NATURE OF THE REPORTED EVENT, IT WAS CONSIDERED RELATED TO ESSURE. A LAPAROSCOPIC PROCEDURE WAS PERFORMED TO REMOVE ESSURE; HENCE THIS CASE IS REGARDED AS AN INCIDENT. PRODUCT TECHNICAL ANALYSIS WAS PERFORMED AND CONCLUDED THAT THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A REPORTER IN UNITED STATES ON (B)(6) 2014 WHICH REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT), LOT NUMBER C80065, INSERTED ON (B)(6) 2014. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2014. THE HEALTH CARE PROFESSIONAL BELIEVED SHE WAS IN THE CORRECT AREA AND RELEASED THE DEVICE. HOWEVER, IT WENT THROUGH THE UTERINE WALL. THE PATIENT HAD A FLAT PLATE X-RAY AND HCP PERFORMED A LAPAROSCOPIC PROCEDURE. DEVICE WAS REMOVED FROM THE UTERINE WALL. THE PATIENT HAD SUCCESSFUL BILATERAL PLACEMENT. PTC INVESTIGATION RESULT WAS RECEIVED ON (B)(6) 2014. THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: PTC LOCAL NUMBER (B)(4) AND PTC GLOBAL NUMBER (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 WOULD INSPECT THE MICRO-INSERT TO CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR AND INSPECT THE DEVICE TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. IN THIS CASE, WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A REQUEST FOR CONFIRMATION OF QUALITY. THE REPORTED ADVERSE EVENT IS A KNOWN POSSIBLE UNDESIRABLE EVENT AND NOT INDICATIVE OF A QUALITY DEFECT PER SE. NO SIMILAR AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO BATCH NO. (B)(4) (PRODUCTION DATE (B)(6) 2014 AND EXPIRATION DATE 31-JUL-2017). NO BATCH SIGNAL COULD BE IDENTIFIED. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER TECHNICAL INVESTIGATION. THE TECHNICAL ASSESSMENT CONCLUDED "UNCONFIRMED QUALITY DEFECT". IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND IT WENT THROUGH THE UTERINE WALL. THIS CASE IS NOT MEDICALLY CONFIRMED. THIS EVENT WAS CONSIDERED SERIOUS DUE TO MEDICAL IMPORTANCE AND LISTED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. UTERINE/FALLOPIAN TUBE PERFORATION MAY OCCUR WITH TRANS-CERVICAL INTRAUTERINE PROCEDURE (E.G. HYSTEROSCOPY, CURETTAGE). IN THIS CASE IT WAS REPORTED THAT THE UTERINE PERFORATION OCCURRED DURING ESSURE INSERTION. GIVEN THE NATURE OF THE REPORTED EVENT, IT WAS CONSIDERED RELATED TO ESSURE. A LAPAROSCOPIC PROCEDURE WAS PERFORMED TO REMOVE ESSURE; HENCE THIS CASE IS REGARDED AS AN INCIDENT. PRODUCT TECHNICAL ANALYSIS WAS PERFORMED AND CONCLUDED THAT THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT. FOLLOW-UP INFORMATION (PERFORATION QUESTIONNAIRE) IS BEING SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673422 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 C80065

    Patients

    Seq Age Sex Outcome Treatment
    1 Other