BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3955151 · Received July 10, 2014

    Report

    Report Number
    2951250-2014-00275
    Event Type
    Injury
    Date Received
    July 10, 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
    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 (B)(4) 2014: ANOTHER TELEVISION INTERVIEW WAS DONE AND IT WAS REPORTED THAT THE ONE WOMAN ENDED UP GETTING PREGNANT. SHE COULDN'T HAVE THE COIL REMOVED AND IN THE (B)(6) WEEK OF THE PREGNANCY ESSURE BROKE AND MIGRATED, PERFORATING THE AMNIOTIC FLUID. THE CHILD DIDN'T MAKE IT. THIS CASE WAS UPGRADED TO INCIDENT DUE TO PREGNANCY COMPLICATIONS. THE LINKED CASE FOR THE CHILD IS (B)(4). PRODUCT TECHNICAL COMPLAINT INVESTIGATION AND FINAL ASSESSMENT WERE RECEIVED ON (B)(4) 2014: THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: (B)(4). FINAL ASSESSMENT: WHEN A TERM LIKE "BROKE" IS USED WHEN DESCRIBING A DEVICE EVENT, IT IS DIFFICULT TO DETERMINE THE TRUE NATURE OF THE EVENT FROM THE COMPLAINT DESCRIPTION ALONE. UNLESS ADDITIONAL DETAIL IS PROVIDED IN THE EVENT DESCRIPTION, IT IS DIFFICULT TO DETERMINE IF THE REPORTER IS DESCRIBING AN EVENT WHERE THE MICRO-INSERT ACTUALLY BROKE INTO INDIVIDUAL PIECES. 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, THE OUTER CATHETER, THE INNER CATHETER, AND ALL PARTS WITHIN THE HANDLE ASSEMBLY TO CONFIRM THAT ALL ARE WITHIN MANUFACTURING E SPECIFICATIONS. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. SINCE NEITHER PRODUCT WAS RETURNED FOR INSPECTION NOR DO WE HAVE A S PHOTOGRAPH OF THE ACTUAL DEVICE, WE CANNOT DETERMINE EXACTLY WHAT THE FAILURE IS. SINCE NO PRODUCT WAS RETURNED FOR INVESTIGATION, WE CANNOT CONFIRM THIS QUALITY COMPLAINT. NO CAPA INVESTIGATION IS REQUIRED AT THIS TIME PER CRITERIA ESTABLISHED IN (B)(4), PROCESSING ESSURE CASES IN (B)(4): LACK OF EFFECTIVENESS MAY OCCUR WITH THE USE OF ANY PRODUCT AND PREGNANCY MAY OCCUR DURING ANY CONTRACEPTIVE USE. BOTH OF THESE EVENTS ARE POSSIBLE UNDESIRABLE EVENTS WITH THE USE OF ESSURE AND ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. THE CASE ALSO REPORTED DIFFICULT TO USE AS THE DEVICES COULD NOT BE REMOVED AND BREAKAGE OF A COIL BUT THESE EVENTS ARE ALSO 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 (B)(4) DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE WITHOUT A BATCH NUMBER. AT THE TIME OF THIS MEDICAL ASSESSMENT THE TECHNICAL INVESTIGATION CONCLUDED "UNCONFIRMED QUALITY DEFECT". BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED, GOT PREGNANT (DEVICE INEFFECTIVE), COULDN'T HAVE IT REMOVED AND IN THE (B)(6) WEEK OF THE PREGNANCY THE COIL BROKE AND MIGRATED, PERFORATING THE AMNIOTIC FLUID LEADING TO PREMATURE LABOUR. HER OUTCOME WAS NOT PROVIDED, THE CHILD DID NOT SURVIVE. THE REPORTED ESSURE BREAKAGE WAS INITIALLY CONSIDERED NON-SERIOUS AND NEAR-INCIDENT, HOWEVER UPON RECEIPT OF FOLLOW-UP INFORMATION THE EVENTS IN THE (B)(6) WEEK OF THE PREGNANCY THE COIL BROKE AND MIGRATED, PERFORATING THE AMNIOTIC FLUID AND PREMATURE LABOUR WERE CONSIDERED SERIOUS AND INCIDENTS DUE TO SIGNIFICANT RISKS OF MORBIDITY TO THE MOTHER. THEY ARE UNLISTED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE, EXCEPT FOR THE REPORTED MIGRATED COIL WHICH IS LISTED. THE REMAINING EVENTS ARE NON-SERIOUS, LISTED, NON-INCIDENTS. UNINTENDED PREGNANCIES MAY OCCUR DURING ANY CONTRACEPTIVE USE AND HAVE BEEN REPORTED IN WOMEN WITH ESSURE MICRO-INSERTS IN PLACE. IN THIS PARTICULAR CASE, IT WAS REPORTED THAT AT (B)(6) WEEKS OF GESTATION, ESSURE COIL BROKE, MIGRATED AND PERFORATED THE AMNIOTIC FLUID (INTERPRETED AS A PRETERM PREMATURE RUPTURE OF MEMBRANES- PPROM). PPROM IS ASSOCIATED WITH PRETERM DELIVERIES (PREMATURE LABOUR) AND MAY POSE SIGNIFICANT RISKS OF MORBIDITY AND MORTALITY FOR BOTH THE FETUS AND THE MOTHER. CLINICAL FACTORS ASSOCIATED WITH ITS OCCURRENCE INCLUDE TOBACCO USE, PRETERM LABOR HISTORY, URINARY INFECTION, VAGINAL BLEEDING, CERCLAGE, AND AMNIOCENTESIS. ALTHOUGH NO INFORMATION WAS PROVIDED ABOUT CONSUMER'S CONCOMITANT CONDITIONS, GIVEN THE GESTATIONAL AGE AT EVENTS OCCURRENCE, A MECHANICAL INTERFERENCE BETWEEN ESSURE AND THE DEVELOPING PREGNANCY CANNOT BE EXCLUDED AND THEY WERE THUS CONSIDERED AS RELATED TO ESSURE. FURTHER INFORMATION CANNOT BE SOUGHT (SOCIAL MEDIA). THE PRODUCT TECHNICAL (PTC) ANALYSIS CONCLUDED THAT BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT IN UNITED STATES RECEIVED ON (B)(4) 2014 FROM TELEVISION CHANNEL WHO INTERVIEWED A CONSUMER WHO HAD ESSURE INSERTED AND THE REPORTER MENTIONED THE OCCURRENCE OF PREGNANCY, DEVICE BREAKAGE AND ESSURE COULD NOT BE REMOVED. INFORMATION WAS RECEIVED FROM THE REPORTER THAT ONE WOMAN GOT THE PROCEDURE, SHE ENDED UP GETTING PREGNANT. SHE COULDN'T HAVE IT REMOVED AND IN THE (B)(6) WEEK OF THE PREGNANCY, THE COIL BROKE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404402 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other