BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10331346 · Received July 28, 2020

    Report

    Report Number
    2951250-2020-12324
    Event Type
    Injury
    Date Received
    July 28, 2020
    Report Date
    December 28, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('MEDICAL DEVICE REMOVAL') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-AUG-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 FALLOPIAN TUBE PERFORATION ('THE ESSURE DEVICE HAD PERFORATED THROUGH THE CORNUA AND REINSERTED INTO THE AMPULLARY PORTION OF THE RIGHT TUBE') AND PELVIC INFLAMMATORY DISEASE ('PELVIC INFLAMMATORY DISEASE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. RIGHT: 875356,LEFT: 979995) INSERTED FOR FEMALE STERILISATION. THE PATIENT'S MEDICAL HISTORY INCLUDED PELVIC INFLAMMATORY DISEASE, GRAND MULTIPARITY, NAUSEA, PARITY 4 AND PELVIC PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DOXYCYCLINE AND ROCEPHIN. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF ESSURE DEVICES BILATERALLY LEFT SALPINGECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION AND PELVIC INFLAMMATORY DISEASE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED FALLOPIAN TUBE PERFORATION AND PELVIC INFLAMMATORY DISEASE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED ESSURE INSERTION DATE AS PER MR IS (B)(6) 2012 AND ESSURE REMOVAL DATE AS PER MR IS (B)(6) 2012 LEFT OSTIA: THERE WAS NOTED TO BE 2 COILS EXTRUDING FROM THE OSTIA. RIGHT OSTIA: THERE WAS NOTED TO BE 4 COILS EXTRUDING FROM THE OSTIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-DEC-2020: MR RECEIVED: "PREVIOUSLY REPORTED EVENT MEDICAL DEVICE REMOVAL REPLACED WITH EVENT FALLOPIAN TUBE PERFORATION. EVENT PELVIC INFLAMMATORY DISEASE ADDED AND MADE MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED DUE TO SURGERY. REPORTER, LOT NUMBER, MEDICAL HISTORY, HISTORICAL DRUG AND RCC 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 FALLOPIAN TUBE PERFORATION ('THE ESSURE DEVICE HAD PERFORATED THROUGH THE CORNUA AND REINSERTED INTO THE AMPULLARY PORTION OF THE RIGHT TUBE') AND PELVIC INFLAMMATORY DISEASE ('PELVIC INFLAMMATORY DISEASE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 875356,979995-BOTH NOT VALID) INSERTED FOR FEMALE STERILISATION. THE PATIENT'S MEDICAL HISTORY INCLUDED PELVIC INFLAMMATORY DISEASE, GRAND MULTIPARITY, NAUSEA, PARITY 4 AND PELVIC PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DOXYCYCLINE AND ROCEPHIN. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PELVIC INFLAMMATORY DISEASE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (REMOVAL OF ESSURE DEVICES BILATERALLY LEFT SALPINGECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION AND PELVIC INFLAMMATORY DISEASE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED FALLOPIAN TUBE PERFORATION AND PELVIC INFLAMMATORY DISEASE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED ESSURE INSERTION DATE AS PER MR IS (B)(6) 2012 AND ESSURE REMOVAL DATE AS PER MR IS (B)(6) 2012 LEFT OSTIA: THERE WAS NOTED TO BE 2 COILS EXTRUDING FROM THE OSTIA. RIGHT OSTIA: THERE WAS NOTED TO BE 4 COILS EXTRUDING FROM THE OSTIA. ESSURE BATCH NO. RIGHT: 875356-NOT VALID ,LEFT: 979995-NOT VALID. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-DEC-2020: QUALITY DEPARTMENT CONFIRMED THAT THE REPORTED ESSURE LOT NUMBERS WERE NOT VALID. 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 MEDICAL DEVICE REMOVAL ('MEDICAL DEVICE REMOVAL') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-APR-2020: PIF RECEIVED: CASE WAS UPGRADED TO SERIOUS INCIDENT. EVENT INJURY WAS REPLACED WITH EVENT MEDICAL DEVICE REMOVAL. REPORTER'S INFORMATION ADDED. 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
    798654 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 875356,979995-BOTH NOT VALID 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R