BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 16577279 · Received March 20, 2023

    Report

    Report Number
    2951250-2023-01509
    Event Type
    Injury
    Date Received
    March 20, 2023
    Date of Event
    March 3, 2016
    Report Date
    November 20, 2023
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 36 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, 92 DAYS AFTER ESSURE INSERTION, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL SURGERY). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: MORE THAN ONE ESSURE RELATED SURGERY-NO. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 17-APR-2023: 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 ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("ESSURE DEVICE MALPOSITIONED JUST DISTAL TO THE UTERINE") AND SALPINGITIS ("FALLOPIAN TUBE WITH FOCAL MILD ACUTE AND CHRONIC INFLAMMATION") IN A 37 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF RIGHT LOWER QUADRANT PAIN ON (B)(6) 2016, SPONTANEOUS ABORTION, PARITY 3 AND MULTI GRAVIDA. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 246 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED) AND SALPINGITIS (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC RIGHT SALPINGECTOMY). AT THE TIME OF THE REPORT, THE OUTCOMES FOR THESE EVENTS WERE UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION AND SALPINGITIS TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: MORE THAN ONE ESSURE RELATED SURGERY-NO. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 64 KG. [PATHOLOGY TEST] ON (B)(6) 2016: SPECIMEN: FALLOPIAN TUBE(S): RIGHT FALLOPIAN TUBE. CLINICAL INFORMATION: RIGHT QUADRANT PAIN. FINAL DIAGNOSIS: RIGHT FALLOPIAN TUBE AND ESSURE WIRE, RIGHT SALPINGECTOMY WITH ESSURE REMOVAL: FALLOPIAN TUBE WITH FOCAL MILD ACUTE AND CHRONIC INFLAMMATION. ESSURE WIRE IDENTIFIED GROSSLY. GROSS DESCRIPTION: THE SPECIMEN IS SERIALLY SECTIONED AND REVEALS A 1.5 BY LESS THAN 0.1 CM COILED WHITE METAL WIRE THAT IS IN THE LUMEN. [ULTRASOUND SCAN VAGINA] ON (B)(6) 2016: ESSURE DEVICE DOES APPEAR TO BE IN RIGHT TUBE BUT JUST DISTAL OF UTERINE CORNUA. GIVEN THIS PLACEMENT, CANNOT CONFIRM ESSURE DEVICE BY US TODAY. HOWEVER, GIVEN PT'S PAIN AND PLACEMENT OF THE DEVICE, IT IS LIKELY WE WOULD BE ABLE TO REMOVE ENTIRE DEVICE BY REMOVING TUBE. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 31-OCT-2023: REPORTERS, PATIENT INFORMATION, MEDICAL HISTORY, LAB DATA, INDICATION, DRUG REMOVAL DATE, EVENT ONSET DATE, NON DRUG TREATMENT ADDED, EVENT MEDICAL DEVICE REMOVAL UPDATED TO DEVICE DISLOCATION AND ADDED A EVENT SALPINGITIS. 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 · 0

    THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, 92 DAYS AFTER ESSURE INSERTION, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL SURGERY). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: MORE THAN ONE ESSURE RELATED SURGERY-NO. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. 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
    366679 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention| O