ESSURE
Report
- Report Number
- 2951250-2018-01105
- Event Type
- Injury
- Date Received
- March 19, 2018
- Report Date
- July 26, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ('POSSIBLE RIGHT ECTOPIC PREGNANCY') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810876) INSERTED FOR FEMALE STERILISATION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED PREGNANCY WITH CONTRACEPTIVE DEVICE IN (B)(6) 2016, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ON (B)(6) 2015, MULTI GRAVIDA, PARITY 3 (DATE OF BIRTH: (B)(6) 2007, (B)(6) 2008, (B)(6) 2009), PREGNANCY WITH CONTRACEPTIVE DEVICE AND TERMINATION OF PREGNANCY. ESSURE DID NOT CAUSED BIRTH DEFECTS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT WAS FOUND TO HAVE AN ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). AT THE TIME OF THE REPORT, THE ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 7, PARA 3. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE WITH ESSURE. THE REPORTER COMMENTED: THIS CASE WAS CREATED TO REFER THE POTENTIAL FOURTH PREGNANCY WITH ESSURE (ECTOPIC PREGNANCY). FOR ECTOPIC PREGNANCY PLEASE REFER TO CASE (B)(4) (FIRST PREGNANCY CASE). FOR SECOND PREGNANCY EPISODE WITH ESSURE PLEASE REFER TO CASE (B)(4). FOR THIRD PREGNANCY EPISODE WITH ESSURE (PREGNANCY WITH TERMINATION) PLEASE REFER TO CASE (B)(4). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON (B)(6) 2016: RESULTS: POSITIVE. DIAGNOSTIC RESULTS: TRANSVAGINAL PELVIC OBSTETRIC ULTRASOUND ON (B)(6) 2016, FINDINGS: TRANSVAGINAL EXAM WAS PERFORMED TO PROVIDE BEST ANATOMY C DEFINITION OF UTERUS , ENDOMETRIUM UM AND EVALUATE ADNEXAL STRUCTURES . THERE WAS A SINGLE INTRAUTERINE PREGNANCY SEEN WITH YOLK SAC AND FETAL POLE SEEN WITHIN GESTATIONAL SAC . NO CARDIAC ACTIVITY IS SEEN ON DOPPLER IMAGING .RIGHT OVARY MEASURES 3 . 3 X 1.7 X 2 . 0 CM. LEFT OVARY MEASURES 2.2 X 1 .4 X 2.0 CM. CERVICAL LENGTH 3 .0 CM . CUL-DE-SAC. IMPRESSION: THERE WAS NO FLUID SEEN IN THE THERE WAS A SINGLE INTRAUTERINE PREGNANCY SEEN . NO FETAL HEART TONES OR CARDIAC ACTIVITY SEEN ON DOPPLER IMAGING. TRANSVAGINAL NONOBSTETRIC PELVIC ULTRASOUND ON (B)(6) 2016, FINDINGS: TRANSVAGINAL EXAM WAS PERFORMED TO PROVIDE BEST ANATOMIC DEFINITION OF UTERUS, ENDOMETRIUM AND EVALUATE ADNEXAL STRUCTURES. UTERUS MEASURES 9.08 X 5.50 X 6.13 CM. CERVIX MEASURES 2.34 CM. THERE WAS HETEROGENEOUS ECHOGENICITY WITHIN THE CENTRAL UTERUS/ENDOMETRIUM, DIAMETER APPROXIMATELY 1.5 CM, WITH SOME FLUID AND SOFT TISSUE ECHOGENICITY WITHIN THE SUPERIOR ENDOMETRIAL CAVITY CONSISTENT WITH MINIMAL RETAINED PRODUCTS OF CONCEPTION AND CLOT. IMPRESSION: THERE WAS HETEROGENEOUS ECHOGENICITY WITHIN THE CENTRAL UTERUS OR ENDOMETRIUM AS WELL AS SOME FLUID AND SOFT TISSUE ECHOGENICITY WITHIN THE SUPERIOR ENDOMETRIAL CAVITY. FINDINGS CONSISTENT WITH MINIMAL RETAINED PRODUCTS OF CONCEPTION AND PROBABLE BLOOD CLOT. ENDOMETRIAL DIAMETER WAS APPROXIMATELY 1.5 CM. THERE WAS NO FREE FLUID SEEN IN THE CUL-DE-SAC. THE PATIENT UNDERWENT A TRANSVAGINAL ULTRASOUND DONE ON (B)(6) 2017, FINDINGS: TRANSVAGINAL EXAM WAS PERFOLTILED TO PROVIDE BEST IN ANATOMIC DEFINITE ION UTERUS, ENDOMETRIUM, AND EVALUATION OF ADNEXAL STRUCTURES, UTERUS MEASURES 7.75 X 3.88 X 4.03 CM. NO INTRAUTERINE PREGNANCY WAS SEEN. RIGHT OVARY MEASURES 3.02 X 2.48 X 2.34 CM, SIMPLE CYST MEASURES 2 X 1.81 X 1.84 CM. THE LEFT OVARY MEASURES 3.15 X 1.56 X 1.64 CM, COMPLEX CYST MEASURES 1.83 X 1.12, THERE WAS VASCULAR NOW SEEN IN EACH OVARY ON DOPPLER IMAGING. IMPRESSION: NO INTRAUTERINE PREGNANCY WAS IDENTIFIED, SIMPLE CYST RIGHT OVARY, COMPLEX CYST LEFT OVARY, ECTOPIC PREGNANCY NOT EXCLUDED. FOLLOW-UP BETA HCG LEVEL AND FOLLOW-UP ULTRASOUND IN 1 TO 2 WEEKS WOULD BE HELPFUL TO EVALUATE FOR PROGRESSION OF PREGNANCY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENT¿S MEDICAL RECORDS: ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE. LOT NUMBER: 810876, MANUFACTURING DATE: 2010-12, EXPIRATION DATE: 2013-12 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 6-JUL-2020: QUALITY-SAFETY EVALUATION OF PTC. INCIDENT: 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.
ROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("POSSIBLE RIGHT ECTOPIC PREGNANCY") IN AN ADULT FEMALE PATIENT (GRAVIDA 7, PARA 3) WHO HAD ESSURE (BATCH NO. 810876) INSERTED FOR FEMALE STERILISATION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTI GRAVIDA, PARITY 3 (DATE OF BIRTH: (B)(6) 2007, (B)(6) 2008, (B)(6) 2009), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ON (B)(6) 2015, PREGNANCY WITH CONTRACEPTIVE DEVICE IN (B)(6) 2016, PREGNANCY WITH CONTRACEPTIVE DEVICE AND TERMINATION OF PREGNANCY. ESSURE DID NOT CAUSED BIRTH DEFECTS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE IN PLACE DURING THE FIRST TRIMESTER OF PREGNANCY. AT THE TIME OF THE REPORT, THE ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE WITH ESSURE. THE REPORTER COMMENTED: THIS CASE WAS CREATED TO REFER THE POTENTIAL FOURTH PREGNANCY WITH ESSURE (ECTOPIC PREGNANCY). FOR ECTOPIC PREGNANCY PLEASE REFER TO CASE (B)(4) (FIRST PREGNANCY CASE). FOR SECOND PREGNANCY EPISODE WITH ESSURE PLEASE REFER TO CASE (B)(4). FOR THIRD PREGNANCY EPISODE WITH ESSURE (PREGNANCY WITH TERMINATION) PLEASE REFER TO CASE (B)(4). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON (B)(6) 2016: POSITIVE TRANSVAGINAL PELVIC OBSTETRIC ULTRASOUND ON (B)(6) 2016, FINDINGS: TRANSVAGINAL EXAM WAS PERFORMED TO PROVIDE BEST ANATOMY C DEFINITION OF UTERUS , ENDOMETRIUM UM AND EVALUATE ADNEXAL STRUCTURES . THERE WAS A SINGLE INTRAUTERINE PREGNANCY SEEN WITH YOLK SAC AND FETAL POLE SEEN WITHIN GESTATIONAL SAC . NO CARDIAC ACTIVITY IS SEEN ON DOPPLER IMAGING .RIGHT OVARY MEASURES 3 . 3 X 1.7 X 2 . 0 CM. LEFT OVARY MEASURES 2.2 X 1 .4 X 2.0 CM. CERVICAL LENGTH 3 .0 CM . CUL-DE-SAC. IMPRESSION: THERE WAS NO FLUID SEEN IN THE THERE WAS A SINGLE INTRAUTERINE PREGNANCY SEEN . NO FETAL HEART TONES OR CARDIAC ACTIVITY SEEN ON DOPPLER IMAGING. TRANSVAGINAL NONOBSTETRIC PELVIC ULTRASOUND ON (B)(4) 2016, FINDINGS: TRANSVAGINAL EXAM WAS PERFORMED TO PROVIDE BEST ANATOMIC DEFINITION OF UTERUS, ENDOMETRIUM AND EVALUATE ADNEXAL STRUCTURES. UTERUS MEASURES 9.08 X 5.50 X 6.13 CM. CERVIX MEASURES 2.34 CM. THERE WAS HETEROGENEOUS ECHOGENICITY WITHIN THE CENTRAL UTERUS/ENDOMETRIUM, DIAMETER APPROXIMATELY 1.5 CM, WITH SOME FLUID AND SOFT TISSUE ECHOGENICITY WITHIN THE SUPERIOR ENDOMETRIAL CAVITY CONSISTENT WITH MINIMAL RETAINED PRODUCTS OF CONCEPTION AND CLOT. IMPRESSION: THERE WAS HETEROGENEOUS ECHOGENICITY WITHIN THE CENTRAL UTERUS OR ENDOMETRIUM AS WELL AS SOME FLUID AND SOFT TISSUE ECHOGENICITY WITHIN THE SUPERIOR ENDOMETRIAL CAVITY. FINDINGS CONSISTENT WITH MINIMAL RETAINED PRODUCTS OF CONCEPTION AND PROBABLE BLOOD CLOT. ENDOMETRIAL DIAMETER WAS APPROXIMATELY 1.5 CM. THERE WAS NO FREE FLUID SEEN IN THE CUL-DE-SAC. THE PATIENT UNDERWENT A TRANSVAGINAL ULTRASOUND DONE ON (B)(6) 2017, FINDINGS: TRANSVAGINAL EXAM WAS PERFOLTILED TO PROVIDE BEST IN ANATOMIC DEFINITE ION UTERUS, ENDOMETRIUM, AND EVALUATION OF ADNEXAL STRUCTURES, UTERUS MEASURES 7.75 X 3.88 X 4.03 CM. NO INTRAUTERINE PREGNANCY WAS SEEN. RIGHT OVARY MEASURES 3.02 X 2.48 X 2.34 CM, SIMPLE CYST MEASURES 2 X 1.81 X 1.84 CM. THE LEFT OVARY MEASURES 3.15 X 1.56 X 1.64 CM, COMPLEX CYST MEASURES 1.83 X 1.12, THERE WAS VASCULAR NOW SEEN IN EACH OVARY ON DOPPLER IMAGING. IMPRESSION: NO INTRAUTERINE PREGNANCY WAS IDENTIFIED, SIMPLE CYST RIGHT OVARY, COMPLEX CYST LEFT OVARY, ECTOPIC PREGNANCY NOT EXCLUDED. FOLLOW-UP BETA HCG LEVEL AND FOLLOW-UP ULTRASOUND IN 1 TO 2 WEEKS WOULD BE HELPFUL TO EVALUATE FOR PROGRESSION OF PREGNANCY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENT¿S MEDICAL RECORDS: ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2018: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINTS. 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.
THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ("POSSIBLE RIGHT ECTOPIC PREGNANCY") IN AN ADULT FEMALE PATIENT (GRAVIDA 7, PARA 3) WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTI GRAVIDA AND PARITY 3 (DATE OF BIRTH: (B)(6)). ESSURE DID NOT CAUSED BIRTH DEFECTS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PATIENT HAD ESSURE DURING THE FIRST TRIMESTER OF PREGNANCY. AT THE TIME OF THE REPORT, THE ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE WITH ESSURE. THE REPORTER COMMENTED: THIS CASE WAS POTENTIAL FOURTH PREGNANCY IDENTIFIED FOR PATIENT (FOR ECTOPIC PREGNANCY). LINKED PREGNANCY CASE (B)(4). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST - ON (B)(6) 2016: POSITIVE; TRANSVAGINAL PELVIC OBSTETRIC ULTRASOUND ON (B)(6) 2016, FINDINGS: TRANSVAGINAL EXAM WAS PERFORMED TO PROVIDE BEST ANATOMY C DEFINITION OF UTERUS, ENDOMETRIUM UM AND EVALUATE ADNEXAL STRUCTURES. THERE WAS A SINGLE INTRAUTERINE PREGNANCY SEEN WITH YOLK SAC AND FETAL POLE SEEN WITHIN GESTATIONAL SAC. NO CARDIAC ACTIVITY IS SEEN ON DOPPLER IMAGING .RIGHT OVARY MEASURES 3.3 X 1.7 X 2.0 CM. LEFT OVARY MEASURES 2.2 X 1.4 X 2.0 CM. CERVICAL LENGTH 3.0 CM. CUL-DE-SAC. IMPRESSION: THERE WAS NO FLUID SEEN IN THE THERE WAS A SINGLE INTRAUTERINE PREGNANCY SEEN. NO FETAL HEART TONES OR CARDIAC ACTIVITY SEEN ON DOPPLER IMAGING. TRANSVAGINAL NONOBSTETRIC PELVIC ULTRASOUND ON (B)(6) 2016, FINDINGS: TRANSVAGINAL EXAM WAS PERFORMED TO PROVIDE BEST ANATOMIC DEFINITION OF UTERUS, ENDOMETRIUM AND EVALUATE ADNEXAL STRUCTURES. UTERUS MEASURES 9.08 X 5.50 X 6.13 CM. CERVIX MEASURES 2.34 CM. THERE WAS HETEROGENEOUS ECHOGENICITY WITHIN THE CENTRAL UTERUS/ENDOMETRIUM, DIAMETER APPROXIMATELY 1.5 CM, WITH SOME FLUID AND SOFT TISSUE ECHOGENICITY WITHIN THE SUPERIOR ENDOMETRIAL CAVITY CONSISTENT WITH MINIMAL RETAINED PRODUCTS OF CONCEPTION AND CLOT. IMPRESSION: THERE WAS HETEROGENEOUS ECHOGENICITY WITHIN THE CENTRAL UTERUS OR ENDOMETRIUM AS WELL AS SOME FLUID AND SOFT TISSUE ECHOGENICITY WITHIN THE SUPERIOR ENDOMETRIAL CAVITY. FINDINGS CONSISTENT WITH MINIMAL RETAINED PRODUCTS OF CONCEPTION AND PROBABLE BLOOD CLOT. ENDOMETRIAL DIAMETER WAS APPROXIMATELY 1.5 CM. THERE WAS NO FREE FLUID SEEN IN THE CUL-DE-SAC. THE PATIENT UNDERWENT A TRANSVAGINAL ULTRASOUND DONE ON (B)(6) 2017, FINDINGS: TRANSVAGINAL EXAM WAS PERFOLTILED TO PROVIDE BEST IN ANATOMIC DEFINITE ION UTERUS, ENDOMETRIUM, AND EVALUATION OF ADNEXAL STRUCTURES, UTERUS MEASURES 7.75 X 3.88 X 4.03 CM. NO INTRAUTERINE PREGNANCY WAS SEEN. RIGHT OVARY MEASURES 3.02 X 2.48 X 2.34 CM, SIMPLE CYST MEASURES 2 X 1.81 X 1.84 CM. THE LEFT OVARY MEASURES 3.15 X 1.56 X 1.64 CM, COMPLEX CYST MEASURES 1.83 X 1.12, THERE WAS VASCULAR NOW SEEN IN EACH OVARY ON DOPPLER IMAGING. IMPRESSION: NO INTRAUTERINE PREGNANCY WAS IDENTIFIED, SIMPLE CYST RIGHT OVARY, COMPLEX CYST LEFT OVARY, ECTOPIC PREGNANCY NOT EXCLUDED. FOLLOW-UP BETA HCG LEVEL AND FOLLOW-UP ULTRASOUND IN 1 TO 2 WEEKS WOULD BE HELPFUL TO EVALUATE FOR PROGRESSION OF PREGNANCY. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENT¿S MEDICAL RECORDS: ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE. 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 |
|---|---|---|---|---|---|---|---|
| 193523 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 810876 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |