BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7066344 · Received November 29, 2017

    Report

    Report Number
    2951250-2017-09273
    Event Type
    Injury
    Date Received
    November 29, 2017
    Date of Event
    January 11, 2013
    Report Date
    August 10, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PERFORATION ("MIGRATION/ PERFORATION OF THE ESSURE DEVICE"), DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE LOCATION: ABDOMEN"), FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBES)") AND GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING.PERMANENT BIRTH CONTROL BY BILATERAL OCCLUSION OF THE FALLOPIAN TUBES") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882183) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED SALPINGECTOMY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: MIERNA IUD REMOVED FROM 2008 TO 11-JAN-2013. CONCURRENT CONDITIONS INCLUDED LOWER ABDOMINAL PAIN, SHOOTING PAIN, BACK PAIN AND WITHDRAWAL BLEEDING IRREGULAR. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE (DEPO PROVERA). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DEVICE DEPLOYMENT ISSUE ("LEFT SIDE TWO COILS"). IN 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, ABDOMINAL PAIN ("CHRONIC ABDOMEN PAIN") AND VULVOVAGINAL PAIN ("CHRONIC VAGINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SHE UNDERWENT A PELVIC SURGERY ON (B)(6) 2013), SURGERY (LEFT SALPHINGECTOMY AND SURGICAL REMOVAL OF ESSURE DEVICE FROM ABDOMEN) AND SURGERY (SALPHINGECTOMY LEFT). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PERFORATION, DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, DYSPAREUNIA, WEIGHT INCREASED AND DEVICE DEPLOYMENT ISSUE OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE HAD RESOLVED AND THE ABDOMINAL PAIN AND VULVOVAGINAL PAIN HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE DEPLOYMENT ISSUE, DEVICE DISLOCATION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, PERFORATION, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: (B)(6) 2013, IT WAS DETERMINED THAT SHE REQUIRED SURGICAL INTERVENTION TO ADDRESS HER COMPLICATIONS AND ALLEVIATE THE SYMPTOMS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: NO FREE INTRAPERITONEAL CONTRAST WAS IDENTIFIED ON (B)(6) 2013, HYSTEROSALPINGOGRAM: IMPRESSION: ESSURE DEVICE IS POSITIONED APPROXIMATELY 4.13 CM LATERAL TO THE RIGHT UTERINE CORNUA. 1.5 CM SUBTLE PROXIMAL RIGHT FALLOPIAN TUBE CONTRAST OPACIFICATION WAS VISUALIZED. NO FREE INTRAPERITONEAL CONTRAST WAS IDENTIFIED MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: PLAINTIFF FACT SHEET AND MEDICAL RECORDS RECEIVED. NEW REPORTERS ADDED AND CASE UPDATED TO MEDICALLY CONFIRM. PATIENT¿S DEMOGRAPHICS, HISTORICAL CONDITION, HISTORICAL DRUG, CONCOMITANT DISEASE AND CONCOMITANT MEDICATIONS ADDED. ESSURE LOT NUMBER AND STOP DATE ADDED AND INDICATION UPDATED. EVENT MIGRATION OF ESSURE DEVICE LOCATION: ABDOMEN, PERFORATION (FALLOPIAN TUBES) WITH PAIN AND LEFT SIDE TWO COILS WAS ADDED. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PERFORATION ("MIGRATION/ PERFORATION OF THE ESSURE DEVICE"), DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE LOCATION: ABDOMEN"), FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBES)") AND GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING / ABNORMAL BLEEDING") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882183) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DEPLOYMENT ISSUE "LEFT SIDE TWO COILS" ON (B)(6) 2013. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED SALPINGECTOMY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: TOPAMAX FROM 2015 TO 2018, MIERNA IUD REMOVED FROM 2008 TO (B)(6) 2013 AND ALLEGRA FROM 2007 TO 2009. CONCURRENT CONDITIONS INCLUDED LOWER ABDOMINAL PAIN, LEG PAIN, BACK PAIN, WITHDRAWAL BLEEDING IRREGULAR AND POLYPS (TREATMENT WAS DONE ON (B)(6) 2018, PROPOSED HYSTERECTOMY.). CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS FROM (B)(6) 2013 FOR CONTRACEPTION, MEDROXYPROGESTERONE (DEPO PROVERA) FROM (B)(6) 2013 FOR CONTRACEPTION NOS, ESTRADIOL SINCE (B)(6) 2013 FOR GENITAL BLEEDING AS WELL AS FEXOFENADINE (ALLEGRA) FROM 2007 TO 2009 AND TOPIRAMATE (TOPAMAX) FROM 2015 TO 2018. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). IN 2013, THE PATIENT EXPERIENCED DYSPAREUNIA ("DYSPAREUNIA") AND WEIGHT INCREASED ("WEIGHT GAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, ABDOMINAL PAIN ("CHRONIC ABDOMEN PAIN") AND VULVOVAGINAL PAIN ("CHRONIC VAGINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (LEFT SALPHINGECTOMY AND SURGICAL REMOVAL OF ESSURE DEVICE FROM ABDOMEN). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PERFORATION, DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, DYSPAREUNIA AND WEIGHT INCREASED OUTCOME WAS UNKNOWN, THE GENITAL HAEMORRHAGE HAD RESOLVED AND THE ABDOMINAL PAIN AND VULVOVAGINAL PAIN HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE DISLOCATION, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, PERFORATION, VULVOVAGINAL PAIN AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: (B)(6) 2013, IT WAS DETERMINED THAT SHE REQUIRED SURGICAL INTERVENTION TO ADDRESS HER COMPLICATIONS AND ALLEVIATE THE SYMPTOMS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: NO FREE INTRAPERITONEAL CONTRAST WAS IDENTIFIED. ON (B)(6) 2013, HYSTEROSALPINGOGRAM: IMPRESSION: ESSURE DEVICE IS POSITIONED APPROXIMATELY 4.13 CM LATERAL TO THE RIGHT UTERINE CORNUA. 1.5 CM SUBTLE PROXIMAL RIGHT FALLOPIAN TUBE CONTRAST OPACIFICATION WAS VISUALIZED. NO FREE INTRAPERITONEAL CONTRAST WAS IDENTIFIED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-AUG-2018: QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. INCIDENT AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PERFORATION ("MIGRATION/PERFORATION OF THE ESSURE DEVICE") AND GENITAL HAEMORRHAGE ("HEAVY AND IRREGULAR BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2013, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DYSPAREUNIA ("DYSPAREUNIA") AND WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (SHE UNDERWENT A PELVIC SURGERY ON (B)(6) 2013). AT THE TIME OF THE REPORT, THE PERFORATION, GENITAL HAEMORRHAGE, DYSPAREUNIA AND WEIGHT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DYSPAREUNIA, GENITAL HAEMORRHAGE, PERFORATION AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: (B)(6) 2013, IT WAS DETERMINED THAT SHE REQUIRED SURGICAL INTERVENTION TO ADDRESS HER COMPLICATIONS AND ALLEVIATE THE SYMPTOMS. INCIDENT. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846292 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 882183

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other| R ALLEGRA| DEPO PROVERA| DEPO PROVERA| ESTRADIOL| ORAL CONTRACEPTIVE NOS| TOPAMAX