ESSURE
Report
- Report Number
- 2951250-2020-13363
- Event Type
- Injury
- Date Received
- August 18, 2020
- Report Date
- August 24, 2020
- 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
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ('RIGHT ESSURE QUESTIONABLY MIGRATED INTO THE ENDOMETRIUM') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841534) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 1 AND GRAVIDA. CONCURRENT CONDITIONS INCLUDED PAIN IN THUMB AND ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DEVICE EXPULSION ("RIGHT ESSURE QUESTIONABLY MIGRATED INTO THE ENDOMETRIUM") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("BECAME PREGNANT AFTER THE INSERTION/6.6 WEEK PREGNANT"). AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, DEVICE EXPULSION AND PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 3, PARA 1. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED DEVICE EXPULSION, EMBEDDED DEVICE AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF EXPERIENCED ANOTHER PREGNANCY ON ESSURE WHICH IS CAPTURED UNDER CASE (B)(4) IN MR ON (B)(6) 2020 SURGERY IS MENTIONED AND SPECIMEN IS ALSO MENTIONED BUT TYPE OF SURGERY AND TYPE OF SPECIMEN IS NOT CLEAR FROM THE SOURCE DOCUMENT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND PELVIS - ON (B)(6) 2019: THE LEFT ESSURE DEVICE APPEARS APPROPRIATE PLACED, BUT THE RIGHT ESSURE DEVICE HAS QUESTIONABLY MIGRATED INTO THE ENDOMETRIUM. CONSIDER DIRECT VISUALIZATION. PROBABLE 2.7 CM UTERINE FIBROID IN THE LEFT FUNDUS. ULTRASOUND SCAN - ON (B)(6) 2013: 6.6 WEEKS HGB: 12.4. BP: 109/70. NVD (NORMAL VAGINAL DELIVERY). AB (ABORTION).; ON (B)(6) 2013: GESTATIONAL AGE: 7.5 WEEKS. UTERUS EMPTY / ADNEXA NEGATIVE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-AUG-2020: 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ('RIGHT ESSURE QUESTIONABLY MIGRATED INTO THE ENDOMETRIUM') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841534) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 1 AND VAGINAL DELIVERY. CONCURRENT CONDITIONS INCLUDED PAIN IN THUMB AND ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DEVICE EXPULSION ("RIGHT ESSURE QUESTIONABLY MIGRATED INTO THE ENDOMETRIUM") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("BECAME PREGNANT AFTER THE INSERTION/6.6 WEEK PREGNANT"). AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, DEVICE EXPULSION AND PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 3, PARA 1. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED DEVICE EXPULSION, EMBEDDED DEVICE AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PLAINTIFF EXPERIENCED ANOTHER PREGNANCY ON ESSURE WHICH IS CAPTURED UNDER CASE (B)(4). IN MR ON (B)(6) 2020 SURGERY IS MENTIONED AND SPECIMEN IS ALSO MENTIONED BUT TYPE OF SURGERY AND TYPE OF SPECIMEN IS NOT CLEAR FROM THE SOURCE DOCUMENT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND PELVIS - ON (B)(6) 2019: THE LEFT ESSURE DEVICE APPEARS APPROPRIATE PLACED, BUT THE RIGHT ESSURE DEVICE HAS QUESTIONABLY MIGRATED INTO THE ENDOMETRIUM. CONSIDER DIRECT VISUALIZATION. PROBABLE 2.7 CM UTERINE FIBROID IN THE LEFT FUNDUS. ULTRASOUND SCAN - ON (B)(6) 2013: 6.6 WEEKS HGB: 12.4. BP: 109/70. NVD (NORMAL VAGINAL DELIVERY). AB (ABORTION).; ON (B)(6) 2013: GESTATIONAL AGE: 7.5 WEEKS. UTERUS EMPTY / ADNEXA NEGATIVE. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 886217 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841534 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |