BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4412675 · Received January 13, 2015

    Report

    Report Number
    2951250-2015-00023
    Event Type
    Injury
    Date Received
    January 13, 2015
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PTC (PRODUCT TECHNICAL COMPLAINT) INVESTIGATION RESULT RECEIVED ON 16-JAN-2015. THE PTC GLOBAL (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 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. NO NEW FAILURE MODE HAS BEEN IDENTIFIED. MEDICAL ASSESSMENT THIS PTC WAS INITIATED DUE TO A REQUEST FOR CONFIRMATION OF QUALITY. THE AE CASE REFERS ALSO TO A USABILITY ISSUE. THE REPORTED ADVERSE EVENT IS A KNOWN POSSIBLE UNDESIRABLE EVENT AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. 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. NEITHER BATCH NUMBER NOR COMPLAINT SAMPLE WERE 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. 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 19-JAN-2015 FOR THE FOLLOWING MEDDRA PREFERRED TERM: DEVICE DISLOCATION. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 294 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. THIS CASE REPORT WAS DERIVED FROM MEDICAL LITERATURE, ARTICLE ENTITLED "THE ESSURE HYSTEROSCOPIC STERILISATION PROCEDURE" WHICH WAS EXTRACTED FROM A LITERATURE REVIEW TITLED "RISK OF ESSURE MICROINSERT ABDOMINAL MIGRATION: CASE REPORT AND REVIEW OF LITERATURE". IT REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND DURING CONFIRMATION TEST LEFT DEVICE WAS IMPROPERLY SITED IN OMENTUM. THE EVENT, SEEN AS DEVICE DISLOCATION, IS SERIOUS DUE MEDICAL IMPORTANCE AND LISTED IN THE ESSURE REFERENCE SAFETY INFORMATION. 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 DISLOCATION (DISTAL FALLOPIAN TUBE OR PERITONEAL CAVITY). IN THIS CASE, THE HYSTEROSALPINGOGRAM PERFORMED AT THREE MONTHS REVEALED A CORRECTLY SITED DEVICE ON THE RIGHT, BUT A MORE DISTAL PLACEMENT ON THE LEFT SIDE. A HYSTEROSCOPY AND TRANSVAGINAL SCAN CONFIRMED THE ABSENCE OF DEVICE ON THE LEFT AND AT A SUBSEQUENT LAPAROSCOPY, THE MIGRATED DEVICE WAS LOCATED ON THE OMENTUM AND WAS EASILY REMOVED. GIVEN THE NATURE OF THE EVENT, CAUSALITY IS ASSESSED AS RELATED TO ESSURE USE. REQUIRED INTERVENTION (LAPAROSCOPY) WAS REPORTED, THEREFORE THE CASE IS REGARDED AS INCIDENT. PRODUCT TECHNICAL COMPLAINT (PTC) ANALYSIS CONCLUDED TO AN UNCONFIRMED QUALITY DEFECT (NO BATCH NUMBER WAS PROVIDED). MEDICAL PTC ASSESSMENT CONSIDERED THAT, BASED ON THE AVAILABLE INFORMATION, THERE IS NO REASON TO SUSPECT QUALITY DEFECT OF THE PRODUCT.

    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 (B)(6) WAS DERIVED FROM MEDICAL LITERATURE "THE ESSURE HYSTEROSCOPIC STERILISATION PROCEDURE" ON 16-DEC-2014. THIS ARTICLE WAS EXTRACTED FROM A LITERATURE REVIEW TITLED "RISK OF ESSURE MICROINSERT ABDOMINAL MIGRATION: CASE REPORT AND REVIEW OF LITERATURE". IT REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED FOR PERMANENT CONTRACEPTION. BAYER DEVICE ESSURE WAS REPORTED. CASE REPORT: IN THIS FEMALE PATIENT OF UNSPECIFIED AGE, NORMALLY SITED DEVICE MIGRATED IN A WOMAN WHO DID NOT EXPERIENCE PAIN AT THE TIME OF THE PROCEDURE. A HYSTEROSALPINGOGRAM AT THREE MONTHS REVEALED IN FACT ABSENT FILLING OF EITHER TUBE, WITH A CORRECTLY SITED DEVICE ON THE RIGHT, BUT A MORE DISTAL PLACEMENT ON THE LEFT SIDE. AN OUTPATIENT HYSTEROSCOPY AND TRANSVAGINAL SCAN CONFIRMED THE ABSENCE OF A CORRECTLY SITED DEVICE ON THE LEFT SIDE AND AT A SUBSEQUENT LAPAROSCOPY, THE MIGRATED DEVICE WAS AGAIN LOCATED ON THE OMENTUM AND EASILY REMOVED. AUTHORS COMMENT: EVEN IF THE MICROINSERT WAS COMPLETELY EMBEDDED INTO THE OMENTUM, NO SIGNS OF INFLAMMATION OR ADHESIONS WERE OBSERVED. DEVICE DISPLACEMENT MIGHT BE EXPLAINED BY THE PRESENCE OF LATERALLY SITED OSTIA, BY TUBAL RESISTANCE, OR BY ENDOMETRIAL CAVITY ADHESIONS. ABSTRACT: ESSURE HYSTEROSCOPIC STERILISATION IS A MINIMALLY INVASIVE, OUTPATIENT APPROACH TO FEMALE STERILISATION, WHICH AVOIDS THE POSSIBLE COMPLICATIONS OF LAPAROSCOPIC STERILISATION. WE PRESENT OUR EXPERIENCE OF THE FIRST 100 CASES OF THE PROCEDURE PERFORMED IN OUR UNIT BETWEEN NOVEMBER 2002 AND NOVEMBER 2005. THE MODIFIED ESSURE DEVICES WERE INTRODUCED IN APRIL 2004 (37 PROCEDURES WERE PERFORMED WITH THE OLD DEVICES AND 63 PROCEDURES WITH THE MODIFIED DEVICES). THE SUCCESSFUL PLACEMENT RATE OVERALL WAS 87%. INSERTION FAILURE, MORE COMMON WITH THE OLDER DEVICES AND IN THE EARLIER PART OF THE SERIES, WAS DUE TO PRE-EXISTING TUBAL DAMAGE IN THE MAJORITY OF CASES. OUR PATIENT SATISFACTION SURVEY REVEALED THAT THE PROCEDURE WAS ASSOCIATED WITH LOW PAIN SCORES AND HIGH SATISFACTION LEVELS. OTHER CASES FROM SAME ARTICLE ARE (B)(4). COMPANY CAUSALITY COMMENT: THIS CASE REPORT WAS DERIVED FROM MEDICAL LITERATURE, ARTICLE ENTITLED "THE ESSURE HYSTEROSCOPIC STERILISATION PROCEDURE" WHICH WAS EXTRACTED FROM A LITERATURE REVIEW TITLED "RISK OF ESSURE MICROINSERT ABDOMINAL MIGRATION: CASE REPORT AND REVIEW OF LITERATURE". IT REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND DURING CONFIRMATION TEST LEFT DEVICE WAS IMPROPERLY SITED IN OMENTUM. THE EVENT, SEEN AS DEVICE DISLOCATION, IS SERIOUS DUE MEDICAL IMPORTANCE AND LISTED IN THE ESSURE REFERENCE SAFETY INFORMATION. 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 DISLOCATION (DISTAL FALLOPIAN TUBE OR PERITONEAL CAVITY). IN THIS CASE, THE HYSTEROSALPINGOGRAM PERFORMED AT THREE MONTHS REVEALED A CORRECTLY SITED DEVICE ON THE RIGHT, BUT A MORE DISTAL PLACEMENT ON THE LEFT SIDE. A HYSTEROSCOPY AND TRANSVAGINAL SCAN CONFIRMED THE ABSENCE OF DEVICE ON THE LEFT AND AT A SUBSEQUENT LAPAROSCOPY, THE MIGRATED DEVICE WAS LOCATED ON THE OMENTUM AND WAS EASILY REMOVED. GIVEN THE NATURE OF THE EVENT, CAUSALITY IS ASSESSED AS RELATED TO ESSURE USE. REQUIRED INTERVENTION (LAPAROSCOPY) WAS REPORTED, THEREFORE, THE CASE IS REGARDED AS INCIDENT. TECHNICAL ANALYSIS HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29460 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS205

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R