ESSURE
Report
- Report Number
- 2951250-2018-01083
- Event Type
- Injury
- Date Received
- March 16, 2018
- Report Date
- July 22, 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 MEDICAL DEVICE REMOVAL ('MEDICAL DEVICE REMOVAL') AND PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY TERMINATION') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810876) INSERTED FOR FEMALE STERILIZATION. 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 AND PARITY 3 (DELIVERIES ON (B)(6) 2007, (B)(6) 2008, (B)(6) 2009). THE PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) SINCE 2011. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED) AND TERMINATION OF PREGNANCY. ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL AND 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, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THIS CASE REFERS TO PLAINTIFF'S PREGNANCY WITH TERMINATION (THIRD PREGNANCY EPISODE WITH ESSURE). FOR THE FIRST PREGNANCY EPISODE WITH ESSURE (ECTOPIC PREGNANCY) PLEASE REFER TO CASE (B)(4). FOR THE SECOND PREGNANCY EPISODE WITH ESSURE PLEASE REFER TO CASE (B)(4). DATE(S) OF INSERTION: UPDATED AS (B)(6) 2008 FROM (B)(6) 2011 00:00. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.5 KG/SQM. 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. 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 MEDICAL DEVICE REMOVAL ('MEDICAL DEVICE REMOVAL') AND PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY TERMINATION') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810876) INSERTED FOR FEMALE STERILIZATION. 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 AND PARITY 3 (DELIVERIES ON (B)(6) 2007, (B)(6) 2008, (B)(6) 2009). THE PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) SINCE 2011. ON (B)(6) 2008, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED) AND TERMINATION OF PREGNANCY. ESSURE WAS REMOVED ON (B)(6)2017. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL AND 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, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THIS CASE REFERS TO PLAINTIFF'S PREGNANCY WITH TERMINATION (THIRD PREGNANCY EPISODE WITH ESSURE). FOR THE FIRST PREGNANCY EPISODE WITH ESSURE (ECTOPIC PREGNANCY) PLEASE REFER TO (B)(4). FOR THE SECOND PREGNANCY EPISODE WITH ESSURE PLEASE REFER TO (B)(4). DATE(S) OF INSERTION: UPDATED AS (B)(6) 2008 FROM (B)(6) 2011 00:00. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.5 KG/SQM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: PIF RECEIVED-REMOVAL WAS ADDED. REPORTERS WERE ADDED. 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.
THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY TERMINATION") IN A FEMALE PATIENT (GRAVIDA 7, PARA 3) WHO HAD ESSURE (BATCH NO. 810876) INSERTED FOR FEMALE STERILIZATION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTI GRAVIDA, PARITY 3 (DELIVERIES ON (B)(6) 2007, (B)(6) 2008, (B)(6) 2009), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ON (B)(6) 2015 AND PREGNANCY WITH CONTRACEPTIVE DEVICE IN (B)(6) 2016. THE PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) SINCE 2011. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED 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, SECOND AND THIRD TRIMESTERS OF PREGNANCY. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THIS CASE REFERS TO PLAINTIFF'S PREGNANCY WITH TERMINATION (THIRD PREGNANCY EPISODE WITH ESSURE). FOR THE FIRST PREGNANCY EPISODE WITH ESSURE (ECTOPIC PREGNANCY) PLEASE REFER TO CASE 2017-043572. FOR THE SECOND PREGNANCY EPISODE WITH ESSURE PLEASE REFER TO CASE 2017-043573. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.5 KG/SQM. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-SEP-2018: QUALITY SAFETY EVALUATION OF PTC. 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 PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY TERMINATION") IN A FEMALE PATIENT (GRAVIDA 7, PARA 3) WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTI GRAVIDA, PARITY 3 (DELIVERIES ON (B)(6) 2007, (B)(6) 2008, (B)(6) 2009), ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ON (B)(6) 2015 AND PREGNANCY WITH CONTRACEPTIVE DEVICE IN (B)(6) 2016. THE PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) SINCE 2011. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED 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, SECOND AND THIRD TRIMESTERS OF PREGNANCY. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THIS CASE REFERS TO PLAINTIFF'S PREGNANCY WITH TERMINATION (THIRD PREGNANCY EPISODE WITH ESSURE). FOR THE FIRST PREGNANCY EPISODE WITH ESSURE (ECTOPIC PREGNANCY) PLEASE REFER TO CASE (B)(4). FOR THE SECOND PREGNANCY EPISODE WITH ESSURE PLEASE REFER TO CASE (B)(4) . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.5 KG/SQM. 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 PTC. 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.
THIS RETROSPECTIVE PREGNANCY CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY TERMINATION") IN A FEMALE PATIENT (GRAVIDA 7, PARA 3) WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTI GRAVIDA AND PARITY 3 (DELIVERIES ON (B)(6) 2007, (B)(6) 2008, (B)(6) 2009). THE PATIENT DID NOT UNDERGO ESSURE CONFIRMATION TEST. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM (XANAX) SINCE 2011. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED 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, SECOND AND THIRD TRIMESTERS OF PREGNANCY. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. THE PREGNANCY OUTCOME WAS REPORTED AS ELECTIVE ABORTION. THE REPORTER CONSIDERED PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THIS CASE REFERS TO PLAINTIFF'S PREGNANCY WITH TERMINATION. (B)(4). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 25.5 KG/SQM. 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 |
|---|---|---|---|---|---|---|---|
| 189407 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 810876 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | XANAX.| XANAX.| XANAX.| XANAX.| XANAX.| XANAX |