BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9069278 · Received September 16, 2019

    Report

    Report Number
    2951250-2019-06482
    Event Type
    Injury
    Date Received
    September 16, 2019
    Date of Event
    January 1, 2013
    Report Date
    February 27, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ('EXPULSION/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT SIDE OF UTERUS') AND MENORRHAGIA ('MENORRHAGIA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 823316) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2013, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN"), DYSMENORRHOEA ("DYSMENORRHEA") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION ON (B)(6) 2013 AND ON (B)(6) 2013 SURGICAL REMOVAL OF LEFT ESSURE COIL DUE TO MIGRATION). AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, PELVIC PAIN, DYSMENORRHOEA, ABDOMINAL PAIN AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN AND THE MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE EXPULSION, DYSMENORRHOEA, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATES OF REMOVAL, (B)(6) 2013 AND (B)(6) 2013 NOTHING YET SCHEDULED TO REMOVE THE REMAINING COIL. DISCREPANCY NOTED IN ESSURE INSERTION DATE - 2006 (AS PER MR). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2007: BILATERAL OCCLUSION, BOTH TUBES WERE BLOCKED. PREGNANCY TEST - ON (B)(6) 2007: NEGATIVE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-JAN-2020: PFS RECEIVED. LOT NUMBER ADDED. EVENT VAGINAL BLEEDING WAS ADDED, OUTCOME OF THE EVENT MENORRHAGIA WAS UPDATED TO RESOLVED. 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

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ('EXPULSION/MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT SIDE OF UTERUS') AND MENORRHAGIA ('MENORRHAGIA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 823316-INV) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. IN 2013, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN"), DYSMENORRHOEA ("DYSMENORRHEA") AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION ON (B)(6) 2013 AND ON (B)(6) 2013 SURGICAL REMOVAL OF LEFT ESSURE COIL DUE TO MIGRATION). AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, PELVIC PAIN, DYSMENORRHOEA, ABDOMINAL PAIN AND VAGINAL HAEMORRHAGE OUTCOME WAS UNKNOWN AND THE MENORRHAGIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE EXPULSION, DYSMENORRHOEA, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATES OF REMOVAL, (B)(6) 2013 AND (B)(6) 2013 NOTHING YET SCHEDULED TO REMOVE THE REMAINING COIL. DISCREPANCY NOTED IN ESSURE INSERTION DATE - 2006 (AS PER MR). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2007: BILATERAL OCCLUSION, BOTH TUBES WERE BLOCKED. PREGNANCY TEST - ON (B)(6) 2007: NEGATIVE. LOT#823316 REPORTED IS INV. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: QUALITY-SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION 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 DEVICE EXPULSION ('BREAKAGE/ EXPULSION: EXPULSION') IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), PELVIC PAIN ("PELVIC PAIN") AND MENORRHAGIA ("MENORRHAGIA"). THE PATIENT WAS TREATED WITH SURGERY. ESSURE (ESS205) WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, DYSMENORRHOEA, ABDOMINAL PAIN, PELVIC PAIN AND MENORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE EXPULSION, DYSMENORRHOEA, MENORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: DISCREPANCY NOTED IN DATES OF REMOVAL, AS THERE IS NO SURGERY MENTIONED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE ON (B)(6) 2007: BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-SEP-2019: PFS RECEIVED: CASE BECOME INCIDENT. UNSPECIFIED EVENT "INJURY TO HERSELF" WAS UPDATED TO MORE SPECIFIC EVENTS: DEVICE EXPULSION, DYSMENORRHEA, ABDOMINAL PAIN, PELVIC PAIN, MENORRHAGIA. REPORTER ADDED, PATIENT DEMOGRAPHIC ADDED, ESSURE INSERTION DATE UPDATED AND REMOVAL DATE ADDED, PRODUCT INDICATION UPDATED. LAB DATA ADDED. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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
    864368 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS205 823316-INV 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other| R