ESSURE
Report
- Report Number
- 2951250-2022-00397
- Event Type
- Injury
- Date Received
- April 12, 2022
- Date of Event
- January 1, 2020
- Report Date
- May 10, 2022
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS LITERATURE CASE WAS REPORTED BY A HEALTHCARE PROFESSIONAL AND DESCRIBES THE OCCURRENCE OF ABNORMAL UTERINE BLEEDING ("ABNORMAL UTERINE HAEMORRHAGE/ABNORMAL UTERINE BLEEDING") AND DEVICE EXPULSION ("INTRAUTERINE MIGRATION OF THE LEFT ESSURE MICROINSERT") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. LITERATURE REFERENCE: FRANCISCO EVORA; INES COUTINHO, FERNANDA AGUAS. ESSURE MIGRATED INTO ENDOMETRIAL CAVITY: AN UNUSUAL ULTRASOUND FINDING;. ACTA OBSTET GINECOL PORT. 2022;: 68-69. THE PATIENT HAD A MEDICAL HISTORY OF GRAVIDA II, HYDROCEPHALUS (DURING CHILDHOOD), PARITY 2 AND VENTRICULO-PERITONEAL SHUNT (VENTRICULOPERITONEAL SHUNT DUE TO HYDROCEPHALUS DURING CHILDHOOD). PATIENT'S MENSTRUAL CYCLES WERE REGULAR. SHE REPORTED A NORMAL AND UNEVENTFUL GYNECOLOGICAL FOLLOWUP. CONCURRENT CONDITIONS WERE LISTED AS FIBROADENOMA OF BREAST, VENOUS INSUFFICIENCY AND DYSLIPIDEMIA (VARICOSE DYSPIPIDEMIA IN LOWER LIMB). ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. IN 2020 SHE EXPERIENCED PARTIAL EXPULSION OF DEVICE (SERIOUSNESS CRITERION INTERVENTION REQUIRED), INTERMENSTRUAL BLEEDING ("INTERMENSTRUAL BLEEDING") AND HEAVY MENSTRUAL BLEEDING ("HEAVY MENSTRUAL BLEEDING"). IN 2021 SHE EXPERIENCED ABNORMAL UTERINE BLEEDING (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED ON (B)(6) 2022. THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL VIA HISTEROSCOPY ON (B)(6) 2022). AT THE TIME OF THE REPORT, ALL OF THE EVENTS HAD RESOLVED. THE REPORTER CONSIDERED ABNORMAL UTERINE BLEEDING, DEVICE EXPULSION AND INTERMENSTRUAL BLEEDING TO BE RELATED TO ESSURE ADMINISTRATION. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO HEAVY MENSTRUAL BLEEDING. THE REPORTER COMMENTED: ESSURE REMOVAL WAS PERFORMED DUE MEDICAL REASON, PRIMARY REASON FOR REMOVAL WAS THE ADVERSE EVENT ABNORMAL UTERINE HAEMORRHAGE, ONSET DATE 2021. THE DEVICE WAS NOT IN CORRECT LOCATION, EXPULSION (INSERT LOCATED IN THE UTERUS, VAGINA, OUTSIDE THE BODY THROUGH THE VAGINA). PATIENT'S SYMPTOMS IMPROVED WITH COMPLETE RESOLUTION WITH 6 OR MORE MONTHS FOLLOWING REMOVAL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX: 20.703 KG/SQM. [GYNAECOLOGICAL EXAMINATION] (DATE UNKNOWN): CERVICAL ECTROPION; PELVIC MASSES NOT FOUND. [HUMAN PAPILLOMA VIRUS TEST] (DATE UNKNOWN): NEGATIVE. [ULTRASOUND SCAN] (DATE UNKNOWN): PRESENCE OF A HYPERECHOGENIC STRUCTURE, WITH ACOILED SHAPE, INTO THE ENDOMETRIAL CAVITY. THERE WAS A SIMILAR SSTRUCTURE IN THE RIGHT UTERINE HORN, BUT ABSENT IN THE LEFT SIDE 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: 08-MAY-2022: ESSURE DEVICE QUESTIONNAIRE REMOVAL RECEIVED AND THE FOLLOWING INFORMATION WAS INCLUDED: PATIENT'S INFORMATION, PATIENT'S DETAILS (DOB, HEIGHT, WEIGHT), MEDICAL HISTORY, START AND STOP DATE, NON-DRUG TREATMENT RECEIVED SURGERY WAS ADDED TO UTERINE HAEMORRHAGE, REPORTER CAUSALITY UPDATED FROM NOT REPORTED TO RELATED. 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.
THIS LITERATURE CASE WAS REPORTED BY A HEALTHCARE PROFESSIONAL AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ("INTRAUTERINE MIGRATION OF THE LEFT ESSURE MICROINSERT") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. LITERATURE REFERENCE: FRANCISCO EVORA; INES COUTINHO, FERNANDA AGUAS. ESSURE MIGRATED INTO ENDOMETRIAL CAVITY: AN UNUSUAL ULTRASOUND FINDING;. ACTA OBSTET GINECOL PORT. 2022;: 68-69. THE PATIENT HAD A MEDICAL HISTORY OF GRAVIDA II, HYDROCEPHALUS (DURING CHILDHOOD), PARITY 2 AND VENTRICULO-PERITONEAL SHUNT (VENTRICULOPERITONEAL SHUNT DUE TO HYDROCEPHALUS DURING CHILDHOOD). PATIENT'S MENSTRUAL CYCLES WERE REGULAR. SHE REPORTED A NORMAL AND UNEVENTFUL GYNECOLOGICAL FOLLOWUP. CONCURRENT CONDITIONS WERE LISTED AS VENOUS INSUFFICIENCY AND DYSLIPIDEMIA. IN 2009, THE PATIENT HAD ESSURE INSERTED. IN 2020 SHE EXPERIENCED PARTIAL EXPULSION OF DEVICE (SERIOUSNESS CRITERION INTERVENTION REQUIRED), ABNORMAL UTERINE BLEEDING ("ABNORMAL UTERINE BLEEDING"), INTERMENSTRUAL BLEEDING ("INTERMENSTRUAL BLEEDING") AND HEAVY MENSTRUAL BLEEDING ("HEAVY MENSTRUAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (OFFICE HYSTEROSCOPY). AT THE TIME OF THE REPORT, ALL OF THE EVENTS HAD RESOLVED. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO DEVICE EXPULSION, ABNORMAL UTERINE BLEEDING, INTERMENSTRUAL BLEEDING OR HEAVY MENSTRUAL BLEEDING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [GYNAECOLOGICAL EXAMINATION] (DATE UNKNOWN): CERVICAL ECTROPION; PELVIC MASSES NOT FOUND [HUMAN PAPILLOMA VIRUS TEST] (DATE UNKNOWN): NEGATIVE [ULTRASOUND SCAN] (DATE UNKNOWN): PRESENCE OF A HYPERECHOGENIC STRUCTURE, WITH ACOILED SHAPE, INTO THE ENDOMETRIAL CAVITY. THERE WAS A SIMILAR SSTRUCTURE IN THE RIGHT UTERINE HORN, BUT ABSENT IN THE LEFT SIDE. 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: 20-APR-2022: QUALITY SAFETY EVALUATION OF PTC. 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.
THIS LITERATURE CASE WAS REPORTED BY A HEALTHCARE PROFESSIONAL AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ("INTRAUTERINE MIGRATION OF THE LEFT ESSURE MICROINSERT") IN AN ADULT FEMALE PATIENT WHO HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED FOR FEMALE STERILIZATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. LITERATURE REFERENCE: FRANCISCO EVORA; INES COUTINHO, FERNANDA AGUAS. ESSURE MIGRATED INTO ENDOMETRIAL CAVITY: AN UNUSUAL ULTRASOUND FINDING;. ACTA OBSTET GINECOL PORT . 2022;: 68-69. THE PATIENT HAD A MEDICAL HISTORY OF VENOUS INSUFFICIENCY, DYSLIPIDEMIA, GRAVIDA II, HYDROCEPHALUS (DURING CHILDHOOD), PARITY 2 AND VENTRICULO-PERITONEAL SHUNT (VENTRICULOPERITONEAL SHUNT DUE TO HYDROCEPHALUS DURING CHILDHOOD ). PATIENT'S MENSTRUAL CYCLES WERE REGULAR. SHE REPORTED A NORMAL AND UNEVENTFUL GYNECOLOGICAL FOLLOWUP. IN 2009, THE PATIENT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ON UNKNOWN DATES SHE EXPERIENCED PARTIAL EXPULSION OF DEVICE (SERIOUSNESS CRITERION INTERVENTION REQUIRED), ABNORMAL UTERINE BLEEDING ("ABNORMAL UTERINE BLEEDING"), INTERMENSTRUAL BLEEDING ("INTERMENSTRUAL BLEEDING") AND HEAVY MENSTRUAL BLEEDING ("HEAVY MENSTRUAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (OFFICE HYSTEROSCOPY ). AT THE TIME OF THE REPORT, ALL OF THE EVENTS HAD RESOLVED. NO CAUSALITY ASSESSMENT WAS RECEIVED FOR FALLOPIAN TUBE OCCLUSION INSERT WITH REGARD TO DEVICE EXPULSION, ABNORMAL UTERINE BLEEDING, INTERMENSTRUAL BLEEDING OR HEAVY MENSTRUAL BLEEDING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [GYNAECOLOGICAL EXAMINATION] (DATE UNKNOWN): CERVICAL ECTROPION; PELVIC MASSES NOT FOUND. [HUMAN PAPILLOMA VIRUS TEST] (DATE UNKNOWN): NEGATIVE. [ULTRASOUND SCAN] (DATE UNKNOWN): PRESENCE OF A HYPERECHOGENIC STRUCTURE, WITH ACOILED SHAPE, INTO THE ENDOMETRIAL CAVITY. THERE WAS A SIMILAR SSTRUCTURE IN THE RIGHT UTERINE HORN, BUT ABSENT IN THE LEFT SIDE 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 |
|---|---|---|---|---|---|---|---|
| 107541 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Female | Required Intervention |