BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10228666 · Received July 3, 2020

    Report

    Report Number
    2951250-2020-10348
    Event Type
    Injury
    Date Received
    July 3, 2020
    Report Date
    September 18, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PERFORATION ('MIGRATION OR PERFORATION') AND DEVICE BREAKAGE ('ESSURE DEVICE IN RIGHT UTERINE CORNEA WAS BROKEN INTO 2 PARTS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 883668-NOT VALID) INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE ESSURE AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PERFORATION AND DEVICE BREAKAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE BREAKAGE AND PERFORATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION DATE PROVIDED IN PIF : (B)(6) 2015. LOT NUMBER REPORTED (883668) IS NOT VALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-SEP-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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PERFORATION ('MIGRATION OR PERFORATION') AND DEVICE BREAKAGE ('ESSURE DEVICE IN RIGHT UTERINE CORNEA WAS BROKEN INTO 2 PARTS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 883668) INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE ESSURE AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PERFORATION AND DEVICE BREAKAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE BREAKAGE AND PERFORATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION DATE PROVIDED IN PIF : (B)(6) 2015. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-AUG-2020: MR RECEIVED: LOT NUMBER WAS ADDED, NEWLY ADDED EVENTS- DEVICE BREAKAGE, REPORTER WAS ADDED. 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 PERFORATION ('MIGRATION OR PERFORATION') AND DEVICE BREAKAGE ('ESSURE DEVICE IN RIGHT UTERINE CORNEA WAS BROKEN INTO 2 PARTS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 883668 - NOT VALID) INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE ESSURE AND BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PERFORATION AND DEVICE BREAKAGE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE BREAKAGE AND PERFORATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION DATE PROVIDED IN PIF : (B)(6) 2015. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-SEP-2020: UPDATE OF INFORMATION (BATCH IS NOT VALID). BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PERFORATION ('MIGRATION OR PERFORATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE ESSURE). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PERFORATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PERFORATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION DATE PROVIDED IN PIF : (B)(6) 2015. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-JUL-2020: QUALITY-SAFETY EVALUATION OF PTC. ON 6-JUL-2020: PIF RECEIVED. NO NEW SIGNIFICANT INFORMATION WAS ADDED. FOLLOW UP 3 AND 4 PROCESSED TOGETHER. 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 PERFORATION ('MIGRATION OR PERFORATION') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE ESSURE). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE PERFORATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED PERFORATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE INSERTION DATE PROVIDED IN PIF: (B)(6) 2015. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-FEB-2020: PIF RECEIVED: CASE WAS UPGRADED TO SERIOUS INCIDENT. EVENT INJURY WAS REPLACED WITH EVENT PERFORATION NOS. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693124 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 883668-NOT VALID 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R