BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9526491 · Received December 27, 2019

    Report

    Report Number
    2951250-2019-14822
    Event Type
    Injury
    Date Received
    December 27, 2019
    Date of Event
    June 28, 2019
    Report Date
    January 15, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 41-YEAR-OLD 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: 10064) HAD FALLOPIAN TUBE OCCLUSION INSERT (BATCH NO. 963571) INSERTED. THE CASE DESCRIBES THE OCCURRENCE OF JOINT DISLOCATION ('LABELING DISLOCATION'). ON (B)(6) 2012, THE SUBJECT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ON (B)(6) 2019, THE SUBJECT EXPERIENCED JOINT DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 6 YEARS 10 MONTHS AFTER INSERTION OF FALLOPIAN TUBE OCCLUSION INSERT. THE SUBJECT WAS TREATED WITH SURGERY (ARTHROSCOPY WITH KNEE JOINT RECONSTRUCTION ON (B)(6) 2019). FALLOPIAN TUBE OCCLUSION INSERT TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE JOINT DISLOCATION HAD NOT RESOLVED. THE INVESTIGATOR CONSIDERED JOINT DISLOCATION TO BE UNRELATED TO FALLOPIAN TUBE OCCLUSION INSERT. THE REPORTER COMMENTED: INVESTIGATOR ASSESSED THE EVENT WAS SEVERE AND SERIOUS DUE TO REQUIRING INTERVENTION, IT WAS UNRELATED TO ESSURE. ALTERNATIVE POSSIBLE EXPLANATION FOR THE EVENT: INTERCURRENT DISEASE SPECIFIED AS "LABELING DISLOCATION", IT WAS A FEMOROPATELLAR INSTABILITY OF THE LEFT KNEE. SURGICAL ARTHROSCOPY WITH KNEE JOINT RECONSTRUCTION WAS PERFORMED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: INVESTIGATOR ANSWERED TO FOLLOW UP REQUEST: THE TERM "DISLOCATION" WAS SPECIFIED AS "A FEMOROPATELLAR INSTABILITY OF THE LEFT KNEE". SURGICAL ARTHROSCOPY WITH KNEE JOINT RECONSTRUCTION WAS PERFORMED. INVESTIGATOR CONSIDERED THE EVENT WAS UNRELATED TO THE ESSURE DEVICES. ESSURE WAS CONTINUED 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.

    Description of Event or Problem · 1

    THIS(B)(6) FEMALE SUBJECT WAS ENROLLED IN A COMPANY-SPONSORED INTERVENTIONAL STUDY TITLED "(B)(6)" (PROTOCOL: (B)(6)). THE SUBJECT (PATIENT ID: (B)(6)) HAD FALLOPIAN TUBE OCCLUSION INSERT (BATCH NO. 963571) INSERTED. THE CASE DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('LABELING DISLOCATION'). ON (B)(6) 2012, THE SUBJECT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ON (B)(6) 2019, THE SUBJECT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 6 YEARS 10 MONTHS AFTER INSERTION OF FALLOPIAN TUBE OCCLUSION INSERT. THE SUBJECT WAS TREATED WITH SURGERY (SURGERY ON (B)(6) 2019). FALLOPIAN TUBE OCCLUSION INSERT TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION HAD NOT RESOLVED. THE INVESTIGATOR CONSIDERED DEVICE DISLOCATION TO BE UNRELATED TO FALLOPIAN TUBE OCCLUSION INSERT. THE REPORTER COMMENTED: INVESTIGATOR ASSESSED THE EVENT WAS SEVERE AND SERIOUS DUE TO REQUIRING INTERVENTION, IT WAS UNRELATED TO ESSURE. ALTERNATIVE POSSIBLE EXPLANATION FOR THE EVENT: INTERCURRENT DISEASE SPECIFIED AS "LABELING DISLOCATION". 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
    1321604 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 963571 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other| R