BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8496052 · Received April 9, 2019

    Report

    Report Number
    2951250-2019-01337
    Event Type
    Injury
    Date Received
    April 9, 2019
    Date of Event
    March 10, 2019
    Report Date
    April 16, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 27-YEAR-OLD FEMALE SUBJECT WAS ENROLLED IN A COMPANY-SPONSORED INTERVENTIONAL STUDY TITLED "AN OPEN-LABEL, NON-RANDOMIZED, PROSPECTIVE OBSERVATIONAL COHORT STUDY TO ASSESS POST-PROCEDURAL OUTCOMES IN TWO COHORTS OF WOMEN WHO CHOSE TO UNDERGO EITHER HYSTEROSCOPIC STERILIZATION (ESSURE) OR LAPAROSCOPIC TUBAL STERILIZATION" (PROTOCOL: 18894). THE SUBJECT (PATIENT ID: (B)(6) HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. THIS CASE DESCRIBES THE OCCURRENCE OF ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("LEFT TUBAL PREGNANCY WITHOUT INTRAUTERINE PREGNANCY"). OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "LEFT TUBAL PREGNANCY WITHOUT INTRAUTERINE PREGNANCY". THE SUBJECT'S MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1 IN 2014, MENARCHE IN 2003, FERTILITY FEMALE DECREASED, CHLAMYDIAL INFECTION NOS AND TRICHOMONAL VAGINITIS. HISTORY OF MISCARRIAGE OR LIVE BIRTH RESULTING IN GENETIC ABNORMALITIES; ABSENCE OF MENSTRUAL/WITHDRAWAL BLEEDING (DURING LAST 6 MONTHS); DYSMENORRHEA (DURING LAST 6 MONTHS); INTRA-CYCLIC BLEEDING (DURING LAST 6 MONTHS); PREMATURE LABOR OR DELIVERY AND MEDICATION PRESCRIPTION TO CONTROL BLEEDING IN THE PAST 2 YEARS WERE DENIED. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IUD. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED PELVIC PAIN WITH IUD. CONCOMITANT PRODUCTS INCLUDED ASCORBIC ACID;CALCIUM CARBONATE;COLECALCIFEROL;CYANOCOBALAMIN;DL-ALPHA TOCOPHERYL ACETATE;FERROUS FUMARATE;FOLIC ACID;LEVOMEFOLIC ACID;MAGNESIUM OXIDE;OMEGA-3 FATTY ACIDS;PYRIDOXINE HYDROCHLORIDE (PRENATE DHA) FROM (B)(6) 2019 AND PYRIDOXINE HYDROCHLORIDE (VITAMIN B6) FROM (B)(6) 2019. ON (B)(6) 2019, THE SUBJECT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ON 10-MAR-2019, THE SUBJECT WAS FOUND TO HAVE AN ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED). THE SUBJECT WAS HOSPITALIZED FROM (B)(6) 2019. THE SUBJECT WAS TREATED WITH OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET) AND SURGERY (LAPAROSCOPY; BILATERAL SALPINGECTOMY). FALLOPIAN TUBE OCCLUSION INSERT WAS REMOVED ON (B)(6) 2019, THE ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE HAD RESOLVED. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE SUBJECT'S OBSTETRIC STATUS WAS GRAVIDA 2, PARA 1. LAST MENSTRUAL PERIOD WAS ON 15-FEB-2019 AND ESTIMATED DATE OF DELIVERY WAS (B)(6) 2019. POTENTIAL FETAL EXPOSURE TO FALLOPIAN TUBE OCCLUSION INSERT OCCURRED DURING THE FIRST TRIMESTER. THE RELATIONSHIP OF ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE TO TREATMENT WITH FALLOPIAN TUBE OCCLUSION INSERT WAS NOT REPORTED. THE REPORTER COMMENTED: ON (B)(6) 2018, THE PATIENT PRESENTED TO EMERGENCY DEPARTMENT WITH THE FOLLOWING SYMPTOMS: MISSED PERIOD THIS MONTH, ABDOMINAL CRAMPING, FATIGUE, AND BREAST TENDERNESS. SHE DENIED ANY PROBLEMS WITH HER PRIOR PREGNANCY. DENIED NAUSEA, VOMITING, DYSURIA, OR VAGINAL BLEEDING. ON (B)(6) 2019, THE PATIENT REPORTED TO EMERGENCY DEPARTMENT FOR ABDOMINAL PAIN FOR 2 WEEKS. SHE ALSO PRESENTED NAUSEA. PATIENT WAS ADMITTED TO HOSPITAL. BASED ON THE ULTRASOUND REPORT THERE WAS CONCERN FOR RUPTURED ECTOPIC PREGNANCY. DIAGNOSTIC LAPAROSCOPY WAS PLANNED TO REMOVE L TUBE AND ECTOPIC MASS. AFTER PROCEDURE ON (B)(6) 2019, THE PATIENT WAS STABLE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 23.9 KG/SQM. HUMAN CHORIONIC GONADOTROPIN - ON (B)(6) 2018: URINE - NEGATIVE; ON (B)(6) 2019: URINE NEGATIVE; ON (B)(6) 2019: 1.785 MIU/ML. LAPAROSCOPY - ON (B)(6) 2019: NORMAL-SIZED ANTEVERTED UTERUS; SMALL 2CM LEFT-SIZED MASS IN LEFT FALLOPIAN TUBE AMPULLA CONSISTENT WITH ECTOPIC PREGNANCY DISTAL TO FILSHIE CLIP. OTHERWISE NORMAL-APPEARING UTERUS, BILATERAL OVARIES, AND RIGHT FALLOPIAN TUBE. BILATERAL FILSHIE CLIPS VISUALIZED ACROSS FALLOPIAN TUBES ~15ML BLOOD IN PELVIS WITHOUT ANY ACTIVE SITES OF BLEEDING.. ULTRASOUND SCAN - ON (B)(6) 2018: BOTH TRANS ABDOMINAL AND TRANSVAGINAL APPROACH: NO IMPLANTATION SITE IS DEMONSTRATED ON THIS STUDY (PREGNANCY OF INDETERMINATE LOCATION).; ON (B)(6) 2019: THICKENED ENDOMETRIUM WITH A THIN, 1 MM SLIP OF FLUID WITHIN. NO CLEAR-CUT SONOLUCENCY IS SEEN TO SUGGEST INTRAUTERINE GESTATIONAL SAC. IN THE LEFT ADNEXA MEDIAL TO THE OVARY, THERE IS A SONOLUCENCY (MEASURING 5 WEEKS 0 DAYS) CONTAINING AN APPARENT YOLK SAC, WITHOUT DISCRETE FETAL POLE SEEN AT THIS TIME. FINDINGS ARE HIGHLY CONCERNING FOR ECTOPIC PREGNANCY. SMALL TO MODERATE AMOUNT OF COMPLEX FREE PELVIC FLUID SEEN IN BOTH ADNEXAL REGIONS.. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-APR-2019: THE CASE WILL BE DELETED FROM BAYER PV DATABASE. NULLIFICATION REASON: UPON FURTHER CLINICAL REVIEW, IT WAS CONFIRMED THAT THIS SUBJECT WAS ACTUALLY IN TREATMENT GROUP ¿LAPAROSCOPIC TUBAL STERILIZATION ¿, NOT RELATED TO ESSURE. THEREFORE, THE PREVIOUSLY INFORMATION SHARED SHOULD BE DISREGARDED. THE SITE WILL BE NOTIFIED TO DISREGARD THE QUERIES SENT AND NO FURTHER QUERIES WILL BE RAISED. ON (B)(6) 2019: NO NEW FURTHER INFORMATION. ON (B)(6) 2019: NO NEW FURTHER INFORMATION. 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 1

    THIS (B)(6) FEMALE SUBJECT WAS ENROLLED IN A COMPANY-SPONSORED INTERVENTIONAL STUDY TITLED (B)(6). THE SUBJECT (PATIENT ID: (B)(6)) HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. THIS CASE DESCRIBES THE OCCURRENCE OF ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("LEFT TUBAL PREGNANCY WITHOUT INTRAUTERINE PREGNANCY"). OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "LEFT TUBAL PREGNANCY WITHOUT INTRAUTERINE PREGNANCY". THE SUBJECT'S MEDICAL HISTORY INCLUDED GRAVIDA I AND PARITY 1. ON AN UNKNOWN DATE, THE SUBJECT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ON AN UNKNOWN DATE, THE SUBJECT WAS FOUND TO HAVE AN ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA HOSPITALIZATION AND INTERVENTION REQUIRED). THE SUBJECT WAS HOSPITALIZED FROM (B)(6) 2019. THE SUBJECT WAS TREATED WITH SURGERY (LAPAROSCOPY; BILATERAL SALPINGECTOMY). FALLOPIAN TUBE OCCLUSION INSERT WAS REMOVED. AT THE TIME OF THE REPORT, THE ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE SUBJECT'S OBSTETRIC STATUS WAS GRAVIDA 2, PARA 1. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO FALLOPIAN TUBE OCCLUSION INSERT OCCURRED DURING THE FIRST TRIMESTER. THE RELATIONSHIP OF ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE TO TREATMENT WITH FALLOPIAN TUBE OCCLUSION INSERT WAS NOT REPORTED. THE REPORTER COMMENTED: ON (B)(6) 2018, THE PATIENT PRESENTED TO EMERGENCY DEPARTMENT WITH THE FOLLOWING SYMPTOMS: MISSED PERIOD THIS MONTH, ABDOMINAL CRAMPING, FATIGUE, AND BREAST TENDERNESS. SHE DENIED ANY PROBLEMS WITH HER PRIOR PREGNANCY. DENIED NAUSEA, VOMITING, DYSURIA, OR VAGINAL BLEEDING. ON (B)(6) 2019, THE PATIENT REPORTED TO EMERGENCY DEPARTMENT FOR ABDOMINAL PAIN FOR 2 WEEKS. SHE ALSO PRESENTED NAUSEA. PATIENT WAS ADMITTED TO HOSPITAL. BASED ON THE ULTRASOUND REPORT THERE WAS CONCERN FOR RUPTURED ECTOPIC PREGNANCY. DIAGNOSTIC LAPAROSCOPY WAS PLANNED TO REMOVE L TUBE AND ECTOPIC MASS. AFTER PROCEDURE ON (B)(6) 2019, THE PATIENT WAS STABLE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HUMAN CHORIONIC GONADOTROPIN - ON (B)(6) 2018: NEGATIVE; ON (B)(6) 2018: POSITIVE. LAPAROSCOPY - ON (B)(6) 2019: NORMAL-SIZED ANTEVERTED UTERUS; SMALL 2CM LEFT-SIZED MASS IN LEFT FALLOPIAN TUBE AMPULLA CONSISTENT WITH ECTOPIC PREGNANCY DISTAL TO FILSHIE CLIP. OTHERWISE NORMAL-APPEARING UTERUS, BILATERAL OVARIES, AND RIGHT FALLOPIAN TUBE. BILATERAL FILSHIE CLIPS VISUALIZED ACROSS FALLOPIAN TUBES ~15ML BLOOD IN PELVIS WITHOUT ANY ACTIVE SITES OF BLEEDING. ULTRASOUND SCAN - ON (B)(6) 2018: BOTH TRANS ABDOMINAL AND TRANSVAGINAL APPROACH: NO IMPLANTATION SITE IS DEMONSTRATED ON THIS STUDY (PREGNANCY OF INDETERMINATE LOCATION).; ON (B)(6) 2019: THICKENED ENDOMETRIUM WITH A THIN, 1 MM SLIP OF FLUID WITHIN. NO CLEAR-CUT SONOLUCENCY IS SEEN TO SUGGEST INTRAUTERINE GESTATIONAL SAC. IN THE LEFT ADNEXA MEDIAL TO THE OVARY, THERE IS A SONOLUCENCY (MEASURING 5 WEEKS 0 DAYS) CONTAINING AN APPARENT YOLK SAC, WITHOUT DISCRETE FETAL POLE SEEN AT THIS TIME. FINDINGS ARE HIGHLY CONCERNING FOR ECTOPIC PREGNANCY. SMALL TO MODERATE AMOUNT OF COMPLEX FREE PELVIC FLUID SEEN IN BOTH ADNEXAL REGIONS. 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288151 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| R PRENATE DHA| VITAMIN B6