BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8626023 · Received May 20, 2019

    Report

    Report Number
    2951250-2019-01984
    Event Type
    Injury
    Date Received
    May 20, 2019
    Date of Event
    June 6, 2018
    Report Date
    May 30, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ADULT FEMALE SUBJECT WAS ENROLLED IN A COMPANY-SPONSORED INTERVENTIONAL STUDY TITLED "USE OF TRANSVAGINAL ULTRASOUND TO CONFIRM ESSURE MICRO-INSERT PLACEMENT IN WOMEN: DEMONSTRATION OF EFFECTIVENESS" (PROTOCOL: 16974). THE SUBJECT (PATIENT ID: 23037) HAD FALLOPIAN TUBE OCCLUSION INSERT (BATCH NO. A33562) INSERTED. THE CASE DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN (LQR)'). THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE SUBJECT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ON (B)(6) 2018, THE SUBJECT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 5 YEARS 7 MONTHS AFTER INSERTION OF FALLOPIAN TUBE OCCLUSION INSERT. ON AN UNKNOWN DATE, THE SUBJECT EXPERIENCED ARTHRALGIA ("CYCLIC JOINT PAIN"). THE SUBJECT WAS TREATED WITH SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY). FALLOPIAN TUBE OCCLUSION INSERT WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ARTHRALGIA HAD RESOLVED. THE RELATIONSHIP OF ARTHRALGIA TO TREATMENT WITH FALLOPIAN TUBE OCCLUSION INSERT WAS NOT REPORTED. THE INVESTIGATOR CONSIDERED PELVIC PAIN TO BE RELATED TO FALLOPIAN TUBE OCCLUSION INSERT. THE REPORTER COMMENTED: PATHOLOGY REPORT: 3 SMALL FOCI OF ENDOMETRIOSIS ON THE LEFT FALLOPIAN TUBE. NORMAL RIGHT TUBE, NORMAL UTERUS AND OVARIES. NO EVIDENCE OF COIL PERFORATION. LOT NUMBER: A33562 MANUFACTURE DATE: 2012-07 EXPIRATION DATE: 2015-07 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: THE CASE WILL BE DELETED FROM BAYER PV DATABASE. NULLIFICATION REASON: THIS CASE WAS IDENTIFIED AS A DUPLICATE OF CASE (B)(4). NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Additional Manufacturer Narrative · 0

    THIS ADULT FEMALE SUBJECT WAS ENROLLED IN A COMPANY-SPONSORED INTERVENTIONAL STUDY TITLED "USE OF TRANSVAGINAL ULTRASOUND TO CONFIRM ESSURE MICRO-INSERT PLACEMENT IN WOMEN: DEMONSTRATION OF EFFECTIVENESS" (PROTOCOL: (B)(4)). THE SUBJECT (PATIENT ID: (B)(6) ) HAD FALLOPIAN TUBE OCCLUSION INSERT (BATCH NO. A33562) INSERTED. THE CASE DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN (LQR)'). THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE SUBJECT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ON (B)(6) 2018, THE SUBJECT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 5 YEARS 7 MONTHS AFTER INSERTION OF FALLOPIAN TUBE OCCLUSION INSERT. ON AN UNKNOWN DATE, THE SUBJECT EXPERIENCED ARTHRALGIA ("CYCLIC JOINT PAIN"). THE SUBJECT WAS TREATED WITH SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY). FALLOPIAN TUBE OCCLUSION INSERT WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ARTHRALGIA HAD RESOLVED. THE RELATIONSHIP OF ARTHRALGIA TO TREATMENT WITH FALLOPIAN TUBE OCCLUSION INSERT WAS NOT REPORTED. THE INVESTIGATOR CONSIDERED PELVIC PAIN TO BE RELATED TO FALLOPIAN TUBE OCCLUSION INSERT. THE REPORTER COMMENTED: PATHOLOGY REPORT: 3 SMALL FOCI OF ENDOMETRIOSIS ON THE LEFT FALLOPIAN TUBE. NORMAL RIGHT TUBE, NORMAL UTERUS AND OVARIES. NO EVIDENCE OF COIL PERFORATION. LOT NUMBER: A33562 MANUFACTURE DATE: 2012-07, EXPIRATION DATE: 2015-07 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-MAY-2019: QUALITY SAFETY EVALUATION OF PTC. 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 1

    THIS ADULT FEMALE SUBJECT WAS ENROLLED IN A COMPANY-SPONSORED INTERVENTIONAL STUDY TITLED "(B)(6))." THE SUBJECT (PATIENT ID: (B)(6)) HAD FALLOPIAN TUBE OCCLUSION INSERT (BATCH NO. A33562) INSERTED. THIS CASE DESCRIBES THE OCCURRENCE OF PELVIC PAIN ("PELVIC PAIN (LQR)"). THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE SUBJECT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ON (B)(6) 2018, THE SUBJECT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 5 YEARS 7 MONTHS AFTER INSERTION OF FALLOPIAN TUBE OCCLUSION INSERT. ON AN UNKNOWN DATE, THE SUBJECT EXPERIENCED ARTHRALGIA ("CYCLIC JOINT PAIN"). THE SUBJECT WAS TREATED WITH LAPAROSCOPIC BILATERAL SALPINGECTOMY AND FALLOPIAN TUBE OCCLUSION INSERT WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ARTHRALGIA HAD RESOLVED. THE RELATIONSHIP OF ARTHRALGIA TO TREATMENT WITH FALLOPIAN TUBE OCCLUSION INSERT WAS NOT REPORTED. THE INVESTIGATOR CONSIDERED PELVIC PAIN TO BE RELATED TO FALLOPIAN TUBE OCCLUSION INSERT. THE REPORTER COMMENTED: PATHOLOGY REPORT: 3 SMALL FOCI OF ENDOMETRIOSIS ON THE LEFT FALLOPIAN TUBE. NORMAL RIGHT TUBE, NORMAL UTERUS AND OVARIES. NO EVIDENCE OF COIL PERFORATION. 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419662 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 A33562 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other| R