BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 17497211 · Received August 10, 2023

    Report

    Report Number
    2951250-2023-02778
    Event Type
    Injury
    Date Received
    August 10, 2023
    Date of Event
    October 5, 2020
    Report Date
    January 7, 2024
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("ESSURE+REMOVAL") IN A 36 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 901328) FOR FEMALE STERILISATION. CONCURRENT CONDITIONS WERE LISTED AS DYSMENORRHEA AND MENORRHAGIA SINCE 05-OCT-2020. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2020, 3127 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 (ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). 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. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [HYSTEROSALPINGOGRAM] ON (B)(6) 2012: CLINICAL: PATIENT HAS HAD PLACEMENT OF FALLOPIAN TUBE OCCLUSION DEVICES. ASSESS FALLOPIAN TUBE NONPATENCY. FINDINGS: THE BILATERAL FALLOPIAN TUBES ARE TOTALLY OCCLUDED WITH APPROPRIATE POSITION OF THE FALLOPIAN TUBE OCCLUSION DEVICES. [PATHOLOGY TEST] ON (B)(6) 2020: CLINICAL INFORMATION: PRE-OPERATIVE DIAGNOSIS: MENORRHAGIA,DYSMENORRHEA,FOREIGN BODY IN UTERUS. POST-OPERATIVE DIAGNOSIS: PROCEDURE:ROBOTIC ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY. TISSUE REMOVED: UTERUS, BILATERAL FALLOPIAN TUBES,CERVIX,ESSURE COILS. DIAGNOSIS: CERVIX,UTERUS ,BILATERAL FALLOPIAN TUBES: CERVIX,SQUAMOUS METAPLASIA AND MILD CHRONIC INFLAMMATION. ENDOMETRIUM, SECRETORY ENDOMETRIUM. FOREIGN MATERIAL PRESENT CONSISTENT WITH COIL PRESENT. MYOMETRIUM, FOCAL ADENOMYOSIS. BILATERAL FALLOPIAN TUBES, NO DIAGNOSTIC ABNORMALITY. GROSS DESCRIPTION: THE RIGHT AND LEFT CORNUA ARE NOTABLE FOR INDWELLING METALLIC COIL-LIKE DEVICES THAT EXTEND INTO THE RIGHT AND LEFT FALLOPIAN TUBES.THE RIGHT COIL DEVICE HAS AN APPROXIMATE LENGTH OF 3 CM AND A DIAMETER THAT RANGES FROM 0.1 CM TO 0.3 CM. THE LEFT COIL DEVICE HAS AN APPROXIMATE LENGTH OF 3.1 CM AND A DIAMETER THAT RANGES FROM 0.1 CM TO 0.3 CM.THESE COIL DEVICES ARE RETAINED. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 18-SEP-2023: REPORTER INFORMATION,MEDICAL HISTORY,LAB DATA,INDICATION,LOT NO,DRUG START AND STOP DATE,EVENT ONSET DATE,NON DRUG TREATMENT 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 ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("ESSURE+REMOVAL") IN A 36 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 901328) FOR FEMALE STERILISATION. CONCURRENT CONDITIONS WERE LISTED AS DYSMENORRHEA AND MENORRHAGIA SINCE (B)(6) 2020. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2020, 3127 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 (ROBOTIC-ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). 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. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [HYSTEROSALPINGOGRAM] ON (B)(6) 2012: CLINICAL: PATIENT HAS HAD PLACEMENT OF FALLOPIAN TUBE OCCLUSION DEVICES.ASSESS FALLOPIAN TUBE NONPATENCY. FINDINGS: THE BILATERAL FALLOPIAN TUBES ARE TOTALLY OCCLUDED WITH APPROPRIATE POSITION OF THE FALLOPIAN TUBE OCCLUSION DEVICES [PATHOLOGY TEST] ON (B)(6) 2020: CLINICAL INFORMATION: PRE-OPERATIVE DIAGNOSIS: MENORRHAGIA,DYSMENORRHEA,FOREIGN BODY IN UTERUS POST-OPERATIVE DIAGNOSIS: PROCEDURE:ROBOTIC ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY , BILATERAL SALPINGECTOMY. TISSUE REMOVED: UTERUS,BILATERAL FALLOPIAN TUBES,CERVIX,ESSURE COILS. DIAGNOSIS: CERVIX,UTERUS ,BILATERAL FALLOPIAN TUBES : -CERVIX,SQUAMOUS METAPLASIA AND MILD CHRONIC INFLAMMATION -ENDOMETRIUM,SECRETORY ENDOMETRIUM FOREIGN MATERIAL PRESENT CONSISTENT WITH COIL PRESENT. -MYOMETRIUM,FOCAL ADENOMYOSIS -BILATERAL FALLOPIAN TUBES ,NO DIAGNOSTIC ABNORMALITY. GROSS DESCRIPTION: THE RIGHT AND LEFT CORNUA ARE NOTABLE FOR INDWELLING METALLIC COIL-LIKE DEVICES THAT EXTEND INTO THE RIGHT AND LEFT FALLOPIAN TUBES.THE RIGHT COIL DEVICE HAS AN APPROXIMATE LENGTH OF 3 CM AND A DIAMETER THAT RANGES FROM 0.1 CM TO 0.3 CM. THE LEFT COIL DEVICE HAS AN APPROXIMATE LENGTH OF 3.1 CM AND A DIAMETER THAT RANGES FROM 0.1 CM TO 0.3 CM.THESE COIL DEVICES ARE RETAINED. LOT NUMBER: 901328 MANUFACTURE DATE: 2011-09 EXPIRATION DATE: 2014-09-30. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. 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 COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 05-JAN-2024: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS 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 · 0

    THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("ESSURE+REMOVAL") IN A 36 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2020 SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). 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. 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 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
    1759740 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 901328 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention