BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESSURE

    MDR report key: 3884584 · Received June 12, 2014

    Report

    Report Number
    2951250-2014-00219
    Event Type
    Other
    Date Received
    June 12, 2014
    Date of Event
    July 1, 2013
    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
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PTC INVESTIGATION RESULT RECEIVED ON (B)(6) 2014: PTC GLOBAL NUMBER: 2014-(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 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. MEDICAL ASSESSMENT: THE MEDICAL EVENT REPORTED IS A POSSIBLE UNDESIRABLE EVENT WITH THE USE OF ESSURE AND 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 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 MEDICALLY CONFIRMED,SPONTANEOUS CASE REPORT REFERS TO A (B)(6)-YEARS-OLD FEMALE PATIENT HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED CHRONIC PELVIC PAIN. THE SUSPECT INSERT WAS SURGICALLY REMOVED AND THE PATIENT RECOVERED FROM THE EVENT. CHRONIC PELVIC PAIN WAS CONSIDERED SERIOUS DUE TO MEDICAL IMPORTANCE AND IT IS LISTED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. ABDOMINAL, PELVIC AND UNCHARACTERIZED PAIN MAY OCCUR WITH ESSURE THERAPY. IN THIS PARTICULAR CASE,THE PATIENT EXPERIENCED CHRONIC PELVIC PAIN WHICH RESOLVED AFTER ESSURE REMOVAL THROUGH HYSTERECTOMY AND BILATERAL SALPINGECTOMY. THE REPORTER CONSIDERED THAT ESSURE REMOVAL WAS MEDICALLY NECESSARY. CONSIDERING THE ABOVE MENTION INFORMATION, THE POSITIVE TEMPORAL RELATIONSHIP AND DE-CHALLENGE THE REPORTED EVENT WAS CONSIDERED AS RELATED TO ESSURE THERAPY AND THUS AN INCIDENT (DUE TO THE REQUIRED INTERVENTION). ACCORDING TO PRODUCT TECHNICAL COMPLAINT INVESTIGATION RESULTS, THE TECHNICAL INVESTIGATION CONCLUDED "UNCONFIRMED QUALITY DEFECT". 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 RECEIVED FROM A MEDICAL DOCTOR IN UNITED STATES ON (B)(6) 2014 WHICH REFERS TO A (B)(6)-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED CHRONIC PELVIC PAIN. NO INFORMATION GIVEN ON PATIENT HISTORY, PAST DRUGS, CONCURRENT CONDITIONS AND CONCOMITANT MEDICATION. ON (B)(6) 2012 PATIENT HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED FOR PERMANENT CONTRACEPTION. REPORTER WAS NOT ABLE TO INFORM ITS LOT NUMBER AND EXPIRATION DATE. PATIENT HAD BEEN EXPERIENCING CHRONIC PELVIC PAIN SINCE (B)(6)-2013. SHE DID NOT RECEIVE ANY TREATMENT FOR THE EVENT. REPORTER CAUSALITY: THE RELATIONSHIP BETWEEN THE EVENT AND ESSURE WAS NOT REPORTED. FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2014 FROM PHYSICIAN: THE PATIENT WEIGHT AND HEIGHT WERE PROVIDED. IT WAS STATED THAT CERVICAL DILATATION AND GENERAL ANESTHESIA WERE APPLIED DURING INSERTION. ESSURE WAS EASILY INSERTED. DEPO-PROVERA WAS USED AS BACK-UP CONTRACEPTION. ON (B)(6) 2014, A PELVIC ULTRASOUND WAS PERFORMED AND IT WAS NORMAL. ON (B)(6) 2013, HSG WAS PERFORMED AND BOTH TUBES WERE BLOCKED. ESSURE DEVICES WERE IN POSITION. ON (B)(6) 2014, ESSURE WAS REMOVED (IT WAS MEDICALLY NECESSARY). PATIENT WAS EXPERIENCING PAIN. LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY WERE PERFORMED TO REMOVE ESSURE. PATHOLOGY RESULT WAS NORMAL WITH NO INFLAMMATION. NORMAL LOCATION AND CONDITION OF DEVICES. PATIENT RECOVERED FROM PAIN AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348521 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other