ESSURE
Report
- Report Number
- 2951250-2019-01823
- Event Type
- Injury
- Date Received
- May 10, 2019
- Date of Event
- September 1, 2012
- Report Date
- January 3, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION (FALLOPIAN TUBES)"), EMBEDDED DEVICE ("ADHERENCE TO POSTERIOR LEFT UTERUS"), DEVICE EXPULSION ("ADHERENCE TO POSTERIOR LEFT UTERUS") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (NO COMPLICATIONS)") IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880433) INSERTED FOR FEMALE STERILIZATION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) (B)(6) 2011 TO (B)(6) 2012 FOR CONTRACEPTION. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2013, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 1 YEAR 5 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPY, BILATERAL TUBAL LIGATION AND LAPAROSCOPY, BILATERAL TUBAL LIGATION/ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, 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 2. 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, FALLOPIAN TUBE PERFORATION AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAIL: THERE WERE 1 COILS VISIBLE ON THE RIGHT SIDE AND THERE WERE/WAS 2 COILS VISIBLE ON THE LEFT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED) PERFORATION (FALLOPIAN TUBE), OTHER ESSURE ADHERED TO LEFT POSTERIOR UTERUS.; ON (B)(6) 2013: PREGNANCY POSITIVE, ESSURE PERFORATION. PREGNANCY TEST URINE - IN (B)(6) 2012: POSITIVE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: PREGNANCY WITH CONTRACEPTIVE DEVICE, FALLOPIAN TUBE PERFORATION, EMBEDDED DEVICE, DEVICE EXPULSION." QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-MAY-2019: QUALITY SAFETY EVALUATION OF PTC. INCIDENT: WE RECEIVED A LOT NUMBER. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION (FALLOPIAN TUBES)'), EMBEDDED DEVICE ('ADHERENCE TO POSTERIOR LEFT UTERUS'), DEVICE EXPULSION ('ADHERENCE TO POSTERIOR LEFT UTERUS/MIGRATION OF THE ESSURE') AND PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY (NO COMPLICATIONS)') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880433, 890432) INSERTED FOR FEMALE STERILIZATION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 2 ((B)(6) 2008 AND (B)(6) 2011). CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) (B)(6) 2011 TO (B)(6) 2012 FOR CONTRACEPTION AS WELL AS ORAL CONTRACEPTIVE NOS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2013, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 1 YEAR 5 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPY, BILATERAL TUBAL LIGATION AND LAPAROSCOPY, BILATERAL TUBAL LIGATION/ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, 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 2. 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, FALLOPIAN TUBE PERFORATION AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAIL: THERE WERE 1 COILS VISIBLE ON THE RIGHT SIDE AND THERE WERE/WAS 2 COILS VISIBLE ON THE LEFT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED) PERFORATION (FALLOPIAN TUBE), OTHER ESSURE ADHERED TO LEFT POSTERIOR UTERUS.; ON (B)(6) 2013: PREGNANCY POSITIVE, ESSURE PERFORATION. PREGNANCY TEST URINE - IN (B)(6) 2012: POSITIVE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: PREGNANCY WITH CONTRACEPTIVE DEVICE, FALLOPIAN TUBE PERFORATION, EMBEDDED DEVICE, DEVICE EXPULSION." QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-NOV-2019: PFS RECEIVED. LOT NUMBER, CONCOMITANT DRUG AND REPORTER INFORMATION ADDED. INCIDENT: 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION (FALLOPIAN TUBES)'), EMBEDDED DEVICE ('ADHERENCE TO POSTERIOR LEFT UTERUS'), DEVICE EXPULSION ('ADHERENCE TO POSTERIOR LEFT UTERUS/MIGRATION OF THE ESSURE') AND PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY (NO COMPLICATIONS)') IN A 37-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 890432-NOT VALID,880433) INSERTED FOR FEMALE STERILIZATION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED PARITY 2 (B)(6)2008 AND (B)(6)2011). CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA)(B)(6)-2011 TO (B)(6)2012 FOR CONTRACEPTION AS WELL AS ORAL CONTRACEPTIVE NOS. ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6)2012, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6)2013, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 1 YEAR 5 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPY, BILATERAL TUBAL LIGATION AND LAPAROSCOPY, BILATERAL TUBAL LIGATION/ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6)2013. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, 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 2. 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, FALLOPIAN TUBE PERFORATION AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAIL: THERE WERE 1 COILS VISIBLE ON THE RIGHT SIDE AND THERE WERE/WAS 2 COILS VISIBLE ON THE LEFT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6)2013: UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED) PERFORATION (FALLOPIAN TUBE), OTHER ESSURE ADHERED TO LEFT POSTERIOR UTERUS.; ON (B)(6)2013: PREGNANCY POSITIVE, ESSURE PERFORATION. PREGNANCY TEST URINE - IN (B)(6)2012: POSITIVE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: PREGNANCY WITH CONTRACEPTIVE DEVICE, FALLOPIAN TUBE PERFORATION, EMBEDDED DEVICE, DEVICE EXPULSION." QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-DEC-2019: UPDATE OF INFORMATION (BATCH IS NOT VALID). 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("ESSURE REMOVAL, PERFORATION (FALLOPIAN TUBES)"), EMBEDDED DEVICE ("ADHERENCE TO POSTERIOR LEFT UTERUS"), DEVICE EXPULSION ("ADHERENCE TO POSTERIOR LEFT UTERUS") AND PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY (NO COMPLICATIONS)") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880433) INSERTED FOR FEMALE STERILIZATION. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) (B)(6) 2011 TO (B)(6) 2012 FOR CONTRACEPTION. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2013, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 1 YEAR 5 MONTHS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPY, BILATERAL TUBAL LIGATION AND LAPAROSCOPY, BILATERAL TUBAL LIGATION/ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, 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 2. 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, FALLOPIAN TUBE PERFORATION AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: INSERTION DETAIL: THERE WERE 1 COILS VISIBLE ON THE RIGHT SIDE AND THERE WERE/WAS 2 COILS VISIBLE ON THE LEFT. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED) PERFORATION (FALLOPIAN TUBE), OTHER ESSURE ADHERED TO LEFT POSTERIOR UTERUS.; ON (B)(6) 2013: PREGNANCY POSITIVE, ESSURE PERFORATION. PREGNANCY TEST URINE - IN (B)(6) 2012: POSITIVE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: PREGNANCY WITH CONTRACEPTIVE DEVICE, FALLOPIAN TUBE PERFORATION, EMBEDDED DEVICE, DEVICE EXPULSION." MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-MAY-2019: PFS AND MR:LOT NOT ADDED. THE CASE IS INCIDENT. REPORTER INFORMATION WAS ADDED. THIS CASE IS MEDICALLY CONFIRMED. THIS CASE CONCERNS (B)(6) YEAR OLD PATIENT. HER DEMOGRAPHIC WAS ADDED. HER HISTORICAL CONDITIONS WERE ADDED. LAB DATA WAS ADDED. ESSURE INDICATION WAS ADDED. ESSURE REMOVAL DATE WAS ADDED. HER CONCOMITANT MEDICATIONS WERE ADDED. PER PLAINTIFF FACT SHEET: UNSPECIFIED EVENT: INJURY TO HERSELF WAS UPDATED TO MORE SPECIFIC EVENTS: PAIN: ABDOMEN, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), GRAVES DISEASE, FIBROIDS WITH LARGE CLOTS, DYSMENORRHEA (CRAMPING) AND PAIN: LOWER BACK WERE ADDED. SHE WAS RECOVERING FROM THE FOLLOWING EVENTS: PAIN, CRAMPS AND BLEEDING. INCIDENT: 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 392088 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 890432-NOT VALID,880433 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Other| R | DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| DEPO-PROVERA| DEPO-PROVERA |