BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 18148638 · Received November 16, 2023

    Report

    Report Number
    2951250-2023-03325
    Event Type
    Injury
    Date Received
    November 16, 2023
    Report Date
    December 12, 2023
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE INFORMATION FROM A PUBLISHED STUDY WAS REPORTED BY A PHYSICIAN AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("ONLY ONE FALLOPIAN TUBE PERFORATION WHEN TRYING TO DILATE THE TUBAL ORIFICE WITH HYSTEROSCOPIC SCISSORS AS ADHESIONS RELEASED (SUSPECTED UTERINE PERFORATION) - INSERT PLACED - AT CHECK UP FOUND IN ABDOMEN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. LITERATURE REFERENCE: R. BERNARDO AND F. VÁZQUEZ-CAMINO. THE ESSURE SYSTEM AS A METHOD OF PERMANENT FEMALE STERILIZATION. CLIN INVEST GIN OBST.. 2010; 37 (6): 223-232. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INSERTION DIFFICULT ("ONLY ONE FALLOPIAN TUBE PERFORATION OCCURRED, WHEN TRYING TO DILATE THE TUBAL ORIFICE WITH HYSTEROSCOPIC SCISSORS AS ADHESIONS RELEASED") AND COMPLICATION OF DEVICE INSERTION ("ONLY ONE FALLOPIAN TUBE PERFORATION OCCURRED, WHEN TRYING TO DILATE THE TUBAL ORIFICE WITH HYSTEROSCOPIC SCISSORS AS ADHESIONS RELEASED"). THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON UNKNOWN DATES SHE EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY IMPORTANT) AND DEVICE DISLOCATION ("AT THE CHECK-UP, IT WAS VISIBLE FREE IN THE ABDOMEN / ONE DEVICE FREE IN ABDOMEN"). THE REPORTER CONSIDERED FALLOPIAN TUBE PERFORATION TO BE RELATED TO ESSURE ADMINISTRATION. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO DEVICE DISLOCATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [X-RAY OF PELVIS AND HIP] (DATE UNKNOWN): WITHOUT CONTRAST: ONE DEVICE FREE IN ABDOMEN. 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. LITERATURE ABSTRACT: A RETROSPECTIVE STUDY WAS CARRIED OUT WITH A GROUP OF 226 PATIENTS AGE BETWEEN 25 AND 43 YEARS WHO MET INCLUSION CRITERIA (EG NO PREVIOUS TUBAL SURGERY (INCLUDING ECTOPIC PREGNANCY)) AND WHO REQUESTED HYSTEROSCOPIC ESSURE INSERTION IN THE PERIOD BETWEEN OCTOBER 2007 AND OCTOBER 2008. RESULTS: THE PLACEMENT OF THE MICRO INSERTS LASTED BETWEEN 6 AND 15 MINUTES FROM THE START OF THE VAGINOSCOPY. IN NO CASE WAS ANY TYPE OF ANAESTHESIA NECESSARY. SUCCESSFUL PLACEMENT ON THE FIRST ATTEMPT IN 225 PATIENTS. ONLY 1 FALLOPIAN TUBE PERFORATION OCCURRED, WHEN TRYING TO DILATE THE TUBAL ORIFICE WITH HYSTEROSCOPIC SCISSORS AS ADHESIONS WERE RELEASED IN THE TUBAL ORIFICE. AUTHORS THEN PLACED THE INSERT AND, AT THE CHECK-UP, IT WAS VISIBLE FREE IN THE ABDOMEN. IN THIS PATIENT THE INSERT COULD ONLY BE PLACED UNILATERALLY, ALTHOUGH THE OTHER INSERT WAS SUBSEQUENTLY PLACED IN A SECOND ATTEMPT. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 09-DEC-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.

    Description of Event or Problem · 0

    THIS CASE INFORMATION FROM A PUBLISHED STUDY WAS REPORTED BY A PHYSICIAN AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("ONLY ONE FALLOPIAN TUBE PERFORATION WHEN TRYING TO DILATE THE TUBAL ORIFICE WITH HYSTEROSCOPIC SCISSORS AS ADHESIONS RELEASED (SUSPECTED UTERINE PERFORATION) - INSERT PLACED - AT CHECK UP FOUND IN ABDOMEN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. LITERATURE REFERENCE: R. BERNARDO AND F. VÁZQUEZ-CAMINO. THE ESSURE® SYSTEM AS A METHOD OF PERMANENT FEMALE STERILIZATION. CLIN INVEST GIN OBST.. 2010; 37 (6): 223-232. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INSERTION DIFFICULT ("ONLY ONE FALLOPIAN TUBE PERFORATION OCCURRED, WHEN TRYING TO DILATE THE TUBAL ORIFICE WITH HYSTEROSCOPIC SCISSORS AS ADHESIONS RELEASED") AND COMPLICATION OF DEVICE INSERTION ("ONLY ONE FALLOPIAN TUBE PERFORATION OCCURRED, WHEN TRYING TO DILATE THE TUBAL ORIFICE WITH HYSTEROSCOPIC SCISSORS AS ADHESIONS RELEASED"). THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE SHE EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). THE REPORTER CONSIDERED FALLOPIAN TUBE PERFORATION TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [X-RAY OF PELVIS AND HIP] (DATE UNKNOWN): WITHOUT CONTRAST: ONE DEVICE FREE IN ABDOMEN. LITERATURE ABSTRACT: A RETROSPECTIVE STUDY WAS CARRIED OUT WITH A GROUP OF 226 PATIENTS AGE BETWEEN 25 AND 43 YEARS WHO MET INCLUSION CRITERIA (EG NO PREVIOUS TUBAL SURGERY (INCLUDING ECTOPIC PREGNANCY)) AND WHO REQUESTED HYSTEROSCOPIC ESSURE INSERTION IN THE PERIOD BETWEEN OCTOBER 2007 AND OCTOBER 2008. RESULTS: THE PLACEMENT OF THE MICRO INSERTS LASTED BETWEEN 6 AND 15 MINUTES FROM THE START OF THE VAGINOSCOPY. IN NO CASE WAS ANY TYPE OF ANAESTHESIA NECESSARY. SUCCESSFUL PLACEMENT ON THE FIRST ATTEMPT IN 225 PATIENTS. ONLY 1 FALLOPIAN TUBE PERFORATION OCCURRED, WHEN TRYING TO DILATE THE TUBAL ORIFICE WITH HYSTEROSCOPIC SCISSORS AS ADHESIONS WERE RELEASED IN THE TUBAL ORIFICE. AUTHORS THEN PLACED THE INSERT AND, AT THE CHECK-UP, IT WAS VISIBLE FREE IN THE ABDOMEN. IN THIS PATIENT THE INSERT COULD ONLY BE PLACED UNILATERALLY, ALTHOUGH THE OTHER INSERT WAS SUBSEQUENTLY PLACED IN A SECOND ATTEMPT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193885 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other