BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5473445 · Received March 2, 2016

    Report

    Report Number
    2951250-2016-00144
    Event Type
    Injury
    Date Received
    March 2, 2016
    Report Date
    January 23, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    FOLLOW-UP RECEIVED ON 01-AUG-2016. QUALITY-SAFETY EVALUATION OF PTC: PTC GLOBAL NUMBER (B)(4). NO SAMPLE AVAILABLE FOR THIS INVESTIGATION. 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, ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENT CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENT IS A KNOWN POSSIBLE UNDESIRABLE EVENT AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. COMPANY CAUSALITY COMMENT: THIS CASE REPORT WAS DERIVED FROM MEDICAL LITERATURE AND REFERS TO A FEMALE PATIENT WHO WAS SUBMITTED TO A LAPAROSCOPIC REMOVAL OF ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) DUE TO PERSISTENT PELVIC PAIN. THIS EVENT IS LISTED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. ABDOMINAL, PELVIC AND UNCHARACTERIZED PAIN MAY OCCUR WITH ESSURE THERAPY. IN THIS PARTICULAR CASE, IT WAS REPORTED THAT THE PATIENT HAD PERSISTENT PELVIC SINCE ESSURE INSERTION. CONSIDERING THIS POSITIVE TEMPORAL RELATIONSHIP AND IN THE LACK OF AN ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED AND DUE TO THE REQUIRED INSERT REMOVAL THIS CASE WAS REGARDED AS AN INCIDENT. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. NO FURTHER INFORMATION IS EXPECTED.

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING. THE CODE (B)(4) WAS REPLACED WITH (B)(4).

    Description of Event or Problem · 1

    THIS CASE REPORT FROM THE UNITED STATES WAS DERIVED FROM MEDICAL LITERATURE ON 02-FEB-2016 ARTICLE ENTITLED LAPAROSCOPIC REMOVAL OF ESSURE MICROINSERTS. IT REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED PERSISTENT PELVIC PAIN. IN THIS CONFERENCE ABSTRACT, THE AUTHOR NOTES THAT PERSISTENT PELVIC PAIN REQUIRING MICROINSERT REMOVAL CAN BE PERFORMED AT THE PATIENT REQUEST OR DUE TO THE PERSISTENT PELVIC PAIN BEING UNRESPONSIVE TO OTHER TREATMENTS WITH NO OTHER ETIOLOGIES FOUND. AUTHOR NOTES THAT BOTH LAPAROSCOPIC AND HYSTEROSCOPIC REMOVAL APPROACHES HAVE BEEN DESCRIBED. AUTHOR THEN PRESENTED A VIDEO OF ONE TECHNIQUE FOR LAPAROSCOPIC REMOVAL OF ESSURE MICROINSERTS IN A PATIENT WITH PERSISTENT PELVIC PAIN SINCE INSERTION OF HER MICROINSERTS. NO FURTHER INFORMATION WAS REPORTED ABOUT THE PATIENT. COMPANY CAUSALITY COMMENT: THIS CASE REPORT WAS DERIVED FROM MEDICAL LITERATURE AND REFERS TO A FEMALE PATIENT WHO WAS SUBMITTED TO A LAPAROSCOPIC REMOVAL OF ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) DUE TO PERSISTENT PELVIC PAIN. THIS EVENT IS LISTED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. ABDOMINAL, PELVIC AND UNCHARACTERIZED PAIN MAY OCCUR WITH ESSURE THERAPY. IN THIS PARTICULAR CASE, IT WAS REPORTED THAT THE PATIENT HAD PERSISTENT PELVIC SINCE ESSURE INSERTION. CONSIDERING THIS POSITIVE TEMPORAL RELATIONSHIP AND IN THE LACK OF AN ALTERNATIVE EXPLANATION, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED AND DUE TO THE REQUIRED INSERT REMOVAL THIS CASE WAS REGARDED AS AN INCIDENT. A PRODUCT TECHNICAL ANALYSIS IS BEING SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130660 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R