BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5000635 · Received August 13, 2015

    Report

    Report Number
    2951250-2015-00600
    Event Type
    Injury
    Date Received
    August 13, 2015
    Date of Event
    May 15, 2012
    Report Date
    January 20, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATA CORRECTION: THE PRODUCT CODE KNH WAS REPLACED WITH HHS.

    Description of Event or Problem · 1

    THIS IS A CLINICAL STUDY CASE REPORT RECEIVED FROM A GYNECOLOGIST/OBSTETRICIAN IN (B)(6) ON (B)(6)2015 WHICH REFERS TO AN ADULT (>=18Y & <65Y) FEMALE PATIENT WHO WAS INVOLVED IN A INTERVENTIONAL COMPANY-SPONSORED STUDY, STUDY NUMBER: (B)(4). STUDY DESCRIPTION: USE OF TRANSVAGINAL ULTRASOUND TO CONFIRM ESSURE MICRO-INSERT PLACEMENT IN WOMEN: DEMONSTRATION OF EFFECTIVENESS. PATIENT NUMBER: (B)(6). ON (B)(6) 2012, ESSURE WAS INSERTED; THE LOT NUMBER USED WAS 915889. AN ADEQUATE VISUALIZATION OF THE RIGHT AND LEFT TUBAL OSTIA WAS ACHIEVED. AT LEAST ONE ESSURE MICRO-INSERT PASSED THROUGH THE CHANNEL OF THE SCOPE AT ANY TIME DURING THE PROCEDURE. ORAL MEDICATIONS WAS USED AS ANESTHESIA METHOD. PRIOR TO THE PROCEDURE, SUBJECT RECEIVED NAPROXEN 500MG. ON THE SAME DAY OF INSERTION, AN URINE PREGNANCY TEST WAS PERFORMED AND THE RESULT WAS NEGATIVE. HER LAST MENSTRUATION WAS ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT EXPERIENCED INTERMENSTRUAL BLOOD LOSS. THE INVESTIGATOR CONSIDERED THE EVENT RELATED TO STUDY AND THE PATIENT ALSO EXPERIENCED ABDOMINAL PAIN. ON (B)(6) 2014, A NOVASURE PROCEDURE WAS DONE FOR MENORRHAGIA. THE PROBE LENGTH WAS 8 CM; THE CERVIX LENGTH WAS 4 CM AND THE CAVUM LENGTH WAS 4 CM. THE PROCEDURE WAS CONSIDERED UNCOMPLICATED. AFTER THE PROCEDURE, THE PATIENT CONTINUED WITH THE HEAVY INTERMENSTRUAL BLOOD LOSS. ON (B)(6) 2014, A LAPAROSCOPIC HYSTERECTOMY WAS PERFORMED. DURING THE PROCEDURE, THE UTERUS AND ADNEXA WERE WITH NORMAL ASPECTS; THE INSPECTION OF ABDOMEN SHOWED NO ADHESIONS OF OTHER PATHOLOGIES. DURING INSPECTION OF ABDOMEN, SMOOTH LIVER AND NO ADHESIONS OF OTHER PATHOLOGIES WERE VISIBLE. THE PHYSICIAN PERFORMED A BOTH SIDES TUBECTOMY (NOT LOOSED IN TUBA CORNER), AND AFTER THAT BOTH SIDES ROTUNDA WERE TAKEN WITH HELP OF LIGASURE AND LIGAMENTA OVARIA PROPRIAE; BOTH SIDES OF PARAMETRIA AND VASCULAR SYSTEM WHICH WAS DISSECTED WAS GONE THROUGH WITH LIGASURE. THE PHYSICIAN PERFORMED A MOBILIZATION SIGMOID DUE TO SEVERAL ADHESIONS AND OPENING BLADDER PERITONEUM FROM LATERAL AND DISSECTION OF THE BLADDER, HERE MULTIPLE ADHESIONS WERE NOTICED. A BLEEDING IN THE VAGINA BACKSIDE WAS COAGULATED WAS OBSERVED. SUBSEQUENTLY REMOVAL OF UTERUS IN TOTAL BY UTERUS MANIPULATOR WAS DONE. THE FINAL INSPECTION SHOWED A GOOD HEMOSTASIS. THE WOUND CLASS WAS CONSIDERED CLEAN CONTAMINATED. CONCLUSION OF THE PROCEDURE: UNCOMPLICATED LAPAROSCOPIC UTERUS EXTIRPATION WITH TAKING OF TUBA. OVARY LEFT IN SITU. AFTER-TREATMENT/OUTPATIENT FOLLOW-UP: TELEPHONIC CONSULT 2 WEEKS FOR PATIENT AMD CHECK-UP IN 6 WEEKS. THE PATIENT RECOVERED FROM EVENT AFTER ESSURE DISCONTINUATION. FOLLOW-UP INFORMATION RECEIVED ON (B)(6) 2015. LOT NUMBER WAS CONFIRMED TO 915889 (PRODUCTION DATE OCT-2011; EXPIRATION DATE OCT-2014). FOLLOW UP (B)(6) 2015: PTC INVESTIGATION RESULTS WERE PROVIDED. 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 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. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. 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 DEFICIT PER SE. NO SIMILAR AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO THE REPORTED BATCH. NO BATCH SIGNAL COULD BE IDENTIFIED. THE BATCH DOCUMENTATION OF THE REPORTED BATCH WAS REVIEWED. NO COMPLAINT SAMPLE WAS PROVIDED FOR A 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 ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS WITH SIMILAR EVENTS CODED IN (B)(4). IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON (B)(4) 2015 FOR THE FOLLOWING (B)(4) PREFERRED TERM: METRORRHAGIA. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 8 CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THESE MEDDRA PTS. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, CLINICAL STUDY CASE REPORT REFERS TO A FEMALE SUBJECT WHO WAS INVOLVED IN A INTERVENTIONAL COMPANY-SPONSORED STUDY, STUDY NUMBER: (B)(4) AND EXPERIENCED INTERMENSTRUAL BLOOD LOSS. THIS EVENT IS SERIOUS DUE TO HOSPITALIZATION AND LISTED IN THE INVESTIGATOR'S BROCHURE FOR ESSURE. IN THIS CASE, THIS EVENT OCCURRED ABOUT 56 DAYS AFTER ESSURE INSERTION. INVESTIGATOR CONSIDERED THIS EVENT RELATED TO STUDY DEVICE. SUBJECT UNDERWENT AN UNCOMPLICATED LAPAROSCOPIC UTERUS EXTIRPATION WITH TAKING OF TUBA. CONSIDERING THE EVENT NATURE AND BASED ON A POSITIVE TEMPORAL RELATIONSHIP, COMPANY AGREES WITH INVESTIGATOR'S ASSESSMENT AND CONSIDERS THE REPORTED EVENT AS RELATED TO STUDY DEVICE. THIS CASE WAS REGARDED AS INCIDENT DUE TO REQUIRED INTERVENTION AND HOSPITALIZATION. PRODUCT TECHNICAL COMPLAINT (PTC) ANALYSIS CONCLUDED TO AN UNCONFIRMED QUALITY DEFECT. MEDICAL PTC ASSESSMENT CONSIDERED THAT, BASED ON THE AVAILABLE INFORMATION, THERE IS NO REASON TO SUSPECT QUALITY DEFECT OF THE PRODUCT. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533789 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 915889

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R FENTANYL (FENTANYL)