BEUDAMED
    FDA Adverse Event Summary report: N

    ESSURE

    MDR report key: 3890176 · Received June 13, 2014

    Report

    Report Number
    2951250-2014-00225
    Date Received
    June 13, 2014
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 MEDICAL DOCTOR IN UNITED STATES ON (B)(6) 2014. IT DESCRIBES THE OCCURRENCE OF PREGNANCY WITH ESSURE, DEVICE INEFFECTIVE AND THE COIL FOUNDS ITS WAY OUT OF TUBE IN A (B)(6)-YEAR OLD FEMALE PT WHO RECEIVED ESSURE (FALLOPIAN TUBE OCCLUSION INSERTS). NO INFO GIVEN ON PT MEDICAL HISTORY, PAST DRUGS, CONCURRENT CONDITIONS AND CONCOMITANT MEDICATION. ON (B)(6) 2011, THE PT HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERTS) INSERTED FOR PERMANENT STERILIZATION. REPORTER WAS NOT ABLE TO INFORM ITS LOT NUMBER AND EXPIRATION DATE. PHYSICIAN REPORTED THAT THE COIL FOUND ITS WAY OUT OF TUBE. HE REMOVED THE COIL, BUT AFTER GOING BACK OVER THE RECORDS, HE NOTED THAT PT WAS PREGNANT ON (B)(6) 2013. SHE WAS (B)(6) PREGNANT AT THAT TIME ON (B)(6) 2014, PT HAD A FULL-TERM DELIVERY (WITH COIL STILL IN BODY, BUT OUT OF FALLOPIAN TUBE). ON (B)(6) 2014, PHYSICIAN WENT IN SURGICALLY AND REMOVED THE COIL. SURGERY WENT FINE. IT WAS NOT REPORTED IF ONE COIL WAS LEFT IN PT. REPORTER CAUSALITY: THE RELATIONSHIP BETWEEN THE ADVERSE EVENTS AND ESSURE (B)(4) AND LOCAL (B)(4)NUMBERS WERE RECEIVED. RESULT AND ASSESSMENT OF THE PRODUCT TECHNICAL COMPLAINT INVESTIGATION RECEIVED ON (B)(6) 2014: 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. 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. NO CAPA INVESTIGATION IS REQUIRED AT THIS TIME PER CRITERIA ESTABLISHED IN (B)(4), "PROCESSING ESSURE CASES IN (B)(4)". MEDICAL ASSESSMENT: LACK OF EFFECTIVENESS MAY OCCUR WITH THE USE OF ANY PRODUCT. ADDITIONALLY, PREGNANCY MAY OCCUR DURING ANY CONTRACEPTIVE USE. THESE EVENTS, ALONG WITH DISLOCATION OF DEVICE, ARE POSSIBLE UNDESIRABLE EVENTS WITH THE USE OF ESSURE. AND ARE 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. FOLLOW UP FROM (B)(6) 2014: THE REQUIRED NUMBER OF FOLLOW-UP ATTEMPTS HAS BEEN MADE WITH NO RESPONSE TO DATE. CASE CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351291 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other