BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4151078 · Received October 8, 2014

    Report

    Report Number
    2951250-2014-00415
    Event Type
    Injury
    Date Received
    October 8, 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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS CASE REPORT FROM NETHERLANDS WAS DERIVED FROM MEDICAL LITERATURE ON 01-OCT-2008, ARTICLE ENTITLED "UNINTENDED PREGNANCIES AFTER ESSURE STERILIZATION IN THE NETHERLANDS". IT REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE THAT HAD ESSURE (ESS205) (FALLOPIAN TUBE OCCLUSION INSERT) PLACED AND EXPERIENCED A PREGNANCY WITH CONTRACEPTIVE DEVICE AND DEVICE INEFFECTIVE. IT IS UNKNOWN WHETHER THE PATIENT RECEIVED ANY CONCOMITANT MEDICATION. ON AN UNSPECIFIED DATE THE PATIENT HAD ESSURE INSERTED. THE PATIENT EXPERIENCED A PREGNANCY. MISREAD CONFIRMATION TEST AND TIME TO PREGNANCY 7 MONTHS. OUTCOME WAS NOT REPORTED. REPORTER CAUSALITY: THE RELATIONSHIP BETWEEN PREGNANCY WITH CONTRACEPTIVE DEVICE AND DEVICE INEFFECTIVE AND ESSURE (ESS205) WAS NOT REPORTED. [(B)(4)]. FOLLOW-UP (10-SEP-2014): THE PATIENT WAS A (B)(6) MULTIPAROUS (PARITY 2) FEMALE ((B)(6)). SHE WAS INCLUDED IN A RETROSPECTIVE MULTICENTER CASE SERIES AND PARTICIPATED IN A TRAINING COURSE FOR HYSTEROSCOPIC STERILIZATION WITH ESSURE. PATIENT WAS ADVISED TO TAKE A NONSTEROIDAL ANTI-INFLAMMATORY DRUG ON THE EVENING BEFORE AND 1 HOUR BEFORE PLACEMENT OF THE ESSURE MICROINSERTS. AFTER ESSURE INSERTION, SHE UNDERWENT ULTRASOUND FOR CONFIRMATION OF CORRECT DEVICE POSITION. IN 2006, THE PATIENT GOT PREGNANT WHILE ON ESSURE AFTER AN INTERVAL BETWEEN ESSURE PLACEMENT AND PREGNANCY OF 7 MONTHS. THE PROCEDURE IN THIS PATIENT WAS COMPLICATED BY A SPONTANEOUS EXPULSION OF THE FIRST DEVICE AND PLACEMENT OF A THIRD DEVICE. ONLY AN ULTRASOUND EXAMINATION WAS DONE TO CONFIRM BILATERAL LOCALIZATION. SHE HAD A MISINTERPRETATION OF THE ULTRASOUND AT 3 MONTHS OF FOLLOW-UP, HAD A COMPLICATED PLACEMENT, WITH PLACEMENT OF A THIRD DEVICE AFTER A SPONTANEOUS EXPULSION OF THE FIRST DEVICE. DURING LAPAROSCOPIC STERILIZATION AFTER TERMINATION OF PREGNANCY, ONE DEVICE WAS LOCATED INTRAMURALLY UNDER THE SEROSA BECAUSE OF PARTIAL PERFORATION, WHILE THE OTHER ONE WAS IN A PROPER POSITION IN THE OTHER TUBE. AUTHOR'S COMMENT: THE CAUSE OF ESSURE FAILURE IN THIS PATIENT WAS PERFORATION AND NONADHERENCE TO PROTOCOL. ABSTRACT SUMMARY: OBJECTIVE: TO ANALYZE THE DATA OF CASES OF UNINTENDED PREGNANCIES AFTER ESSURE STERILIZATION. DESIGN: RETROSPECTIVE CASE SERIES ANALYSIS. SETTING: NATIONAL MULTICENTER. PATIENT(S): TEN CASES OF UNINTENDED PREGNANCIES AFTER ESSURE STERILIZATION IN THE NETHERLANDS WERE REPORTED FROM AUGUST 2002 THROUGH MAY 2008. INTERVENTION(S): DATA ON THE HYSTEROSCOPIC ESSURE STERILIZATION PROCEDURES AND POSTPROCEDURE CONFIRMATION TESTS OF THE REPORTED CASES WERE REVIEWED AND ANALYZED BY TWO AUTHORS. THE CAUSES OF THE UNINTENDED PREGNANCIES WERE DETERMINED IN AGREEMENT WITH THE PHYSICIANS WHO PERFORMED THE STERILIZATIONS. MAIN OUTCOME MEASURE(S): MOST PREGNANCIES OCCURRED IN PATIENTS WITH ONLY ONE DEVICE PLACEMENT AND BILATERAL OCCLUSION ON HYSTEROSALPINGOGRAPHY (HSG). OTHER CASES INCLUDED MISINTERPRETATION OF HSG, UNDETECTED ABNORMAL DEVICE POSITION BY ULTRASOUND, ONE UNDETECTED PREPROCEDURE PREGNANCY, AND TWO PATIENT FAILURES TO FOLLOW UP WITH THE PHYSICIAN ADVICE. CONCLUSION(S): THE RISK OF PREGNANCY AFTER HYSTEROSCOPIC STERILIZATION MAY BE REDUCED BY STRICTLY FOLLOWING THE FOLLOW-UP PROTOCOL, PERFORMING A URINARY PREGNANCY TEST ON THE DAY OF THE PROCEDURE, AND INSTRUCTING THE PATIENT TO RETURN FOR THE FOLLOW-UP VISIT. A PROCEDURE WITH ONLY A SINGLE DEVICE PLACEMENT IN A PATIENT WITHOUT A HISTORY OF TUBECTOMY OF THE HETEROLATERAL TUBE SHOULD BE CONSIDERED UNSUCCESSFUL. (B)(4). RESULT AND ASSESSMENT OF THE PRODUCT TECHNICAL COMPLAINT INVESTIGATION RECEIVED ON 25-SEP-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 OR DEVICE MALFUNCTION AT THIS TIME. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A LACK OF EFFICACY. CONTRACEPTIVE FAILURE MAY OCCUR UNDER THE USE OF ANY CONTRACEPTIVE AND IS NOT INDICATIVE OF A QUALITY DEFECT PER SE. IN THIS PARTICULAR CASE, ALSO PERFORATION WAS REPORTED WHICH MAY HAVE INCREASED THE RISK OF PREGNANCY. THE AE CASE REFERS ALSO TO A USABILITY ISSUE. NO BATCH NUMBER WAS REPORTED. WITHOUT THIS INFORMATION NO BATCH SIGNAL CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE. NO COMPLAINT SAMPLE WAS PROVIDED FOR 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. THE REFERRED USABILITY ISSUES WILL BE SUBJECT TO POST MARKET SURVEILLANCE MONITORING. (B)(4). THE LIST OF SIMILAR CASES CONTAINS REPORTS WITH SIMILAR EVENTS CODED IN MEDDRA. IT INCLUDES RECENT CASES RECEIVED BY BAYER PHARMA AND OLDER CASES RECEIVED FROM THE PREVIOUS OWNER OF THE ESSURE PRODUCT (CONCEPTUS). THESE LEGACY REPORTS HAVE BEEN RE-CODED ACCORDING TO BAYER PHARMA STANDARDS. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 29-SEP-2014 FOR THE FOLLOWING MEDDRA PREFERRED TERM: EMBEDDED DEVICE. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED (B)(4) CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. THIS INCLUDES CONSIDERATION OF THE LEGACY CASES IN SAFETY ANALYSES. THE CUMULATIVE REVIEW OF THE REPORTS HAS NOT YIELDED ANY NEW SAFETY SIGNAL. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED CASE REPORT WAS DERIVED FROM LITERATURE, ARTICLE ENTITLED "UNINTENDED PREGNANCIES AFTER ESSURE STERILIZATION IN THE NETHERLANDS" AND REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND GOT PREGNANT WITH CONTRACEPTIVE DEVICE. AFTER TERMINATION OF PREGNANCY, A LAPAROSCOPIC STERILIZATION WAS PERFORMED AND ONE DEVICE WAS LOCATED INTRAMURALLY UNDER THE SEROSA BECAUSE OF PARTIAL PERFORATION. THE EVENT ONE DEVICE WAS LOCATED INTRAMURALLY UNDER THE SEROSA BECAUSE OF PARTIAL PERFORATION WAS CONSIDERED AS SERIOUS DUE TO MEDICAL IMPORTANCE WHILE THE PREGNANCY WAS CONSIDERED NON-SERIOUS. BOTH EVENTS ARE LISTED FOR ESSURE IN THE REFERENCE SAFETY INFORMATION. UTERINE/FALLOPIAN PERFORATION MAY OCCUR WITH TRANS-CERVICAL INTRAUTERINE PROCEDURE INCLUDING ESSURE INSERTION. UNINTENDED PREGNANCIES MAY OCCUR DURING ANY CONTRACEPTIVE USE AND HAVE BEEN REPORTED IN WOMEN WITH ESSURE MICRO-INSERTS IN PLACE. SOME OF THESE PREGNANCIES OCCURRED DUE TO PATIENT NON-COMPLIANCE, WHICH INCLUDED FAILURE TO RETURN FOR THE ESSURE CONFIRMATION TEST TO DETERMINE IF THE INSERTS ARE IN THE CORRECT LOCATION AND TUBAL OCCLUSION IS PRESENT. IN THIS PARTICULAR CASE, PATIENT GOT PREGNANT ABOUT 7 MONTHS AFTER ESSURE INSERTION, THE PREGNANCY WAS TERMINATED AND A UTERINE PERFORATION WAS DIAGNOSED DURING A LAPAROSCOPIC STERILIZATION. THE REPORTER ATTRIBUTED ESSURE FAILURE IN THIS PATIENT TO PERFORATION AND NONADHERENCE TO PROTOCOL; HE BELIEVED THAT THERE WAS A MISINTERPRETATION OF THE CONTROL ULTRASOUND AT 3 MONTHS OF FOLLOW-UP; HOWEVER GIVEN THE REPORTED EVENTS NATURE A CAUSAL RELATIONSHIP WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT DUE TO THE REPORTED INTERVENTION (LAPAROSCOPY). ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED: SPONTANEOUS EXPULSION OF THE FIRST DEVICE AND COMPLICATED PLACEMENT. A PRODUCT TECHNICAL COMPLAINT (PTC) ANALYSIS WAS PERFORMED AND CONCLUDED THAT THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT (LACK OF SAMPLE RETURN AND ANY VALID BATCH INFORMATION). NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633160 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other