BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 11803304 · Received May 10, 2021

    Report

    Report Number
    2951250-2021-01818
    Event Type
    Injury
    Date Received
    May 10, 2021
    Report Date
    May 19, 2021
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 823314-NOT VALID, 621688) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1 AND D & C. CONCURRENT CONDITIONS INCLUDED ENDOMETRIAL ADENOCARCINOMA, ATYPICAL HYPERPLASIA OF ENDOMETRIUM, MORBID OBESITY AND HYPERTENSION. ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), HEAVY MENSTRUAL BLEEDING ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND FATIGUE ("FATIGUE"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC-ASSISTED HYSTERECTOMY WITH BILATERAL SALPINGOOOPHORECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSPAREUNIA, BACK PAIN, ABDOMINAL PAIN, HEAVY MENSTRUAL BLEEDING AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA, FATIGUE, HEAVY MENSTRUAL BLEEDING AND PELVIC PAIN TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE OF ESSURE INSERTION: (B)(6) 2007, (B)(6) 2017 THE PATIENT HAD HYSTERECTOMY, SALPINGECTOMY AND OOPHORECTOMY. BOTH OSTIA WERE IDENTIFIED THE LEFT OSTIUM WAS CANNULATED WITH THE ESSURE IMPLANT AND THE IMPLANT WAS DEPLOYED SHOWING FOUR COILS. AS PER MR, DISCREPANCY NOTED IN DATE OF REMOVAL: ON (B)(6) 2019. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2007: ESSURE CONFIRMATION TEST(S)(UNSPECIFIED) :BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: HEAVY MENSTRUAL BLEEDING LOT NUMBER REPORTED 823314 IS NOT VALID. LOT NUMBER: 621688, MANUFACTURING DATE: 2006-11, AND EXPIRATION DATE: 2008-10. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-MAY-2021: UPDATE OF INFORMATION (BATCH IS NOT VALID). ON 12-MAY-2021: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 621688, 823314) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1 AND D & C. CONCURRENT CONDITIONS INCLUDED ENDOMETRIAL ADENOCARCINOMA, ATYPICAL HYPERPLASIA OF ENDOMETRIUM, MORBID OBESITY AND HYPERTENSION. ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), BACK PAIN ("BACK PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), HEAVY MENSTRUAL BLEEDING ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)") AND FATIGUE ("FATIGUE"). THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC-ASSISTED HYSTERECTOMY WITH BILATERAL SALPINGOOOPHORECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSPAREUNIA, BACK PAIN, ABDOMINAL PAIN, HEAVY MENSTRUAL BLEEDING AND FATIGUE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA, FATIGUE, HEAVY MENSTRUAL BLEEDING AND PELVIC PAIN TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATE OF ESSURE INSERTION: (B)(6) 2007, (B)(6) 2017. THE PATIENT HAD HYSTERECTOMY, SALPINGECTOMY AND OOPHORECTOMY. BOTH OSTIA WERE IDENTIFIED THE LEFT OSTIUM WAS CANNULATED WITH THE ESSURE IMPLANT AND THE IMPLANT WAS DEPLOYED SHOWING FOUR COILS. AS PER MR, DISCREPANCY NOTED IN DATE OF REMOVAL: (B)(6) 2019. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2007: ESSURE CONFIRMATION TEST(S)(UNSPECIFIED) :BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: HEAVY MENSTRUAL BLEEDING. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-APR-2021: THIS CASE BECOME SERIOUS INCIDENT. MR RECEIVED. REPORTER INFORMATION, PATIENT'S MEDICAL HISTORY, LOT NUMBER AND RCC WERE ADDED. MODEL NUMBER AND IMPLANT DATE WAS UPDATED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694349 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS205 823314-NOTVALID, 621688 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R