ESSURE
Report
- Report Number
- 2951250-2017-06631
- Event Type
- Injury
- Date Received
- November 15, 2017
- Date of Event
- January 1, 2011
- Report Date
- October 15, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION/FALLOPIAN TUBE PERFORATION/RIGHT PERFORATED TUBE/PIECE OF RIGHT COIL PERFORATED TUBE/PERFORATING RIGHT COIL PERITUBAL"), DEVICE BREAKAGE ("DEVICE FRACTURE/DEVICE BREAKAGE FOUND A PIECE OF RIGHT SIDE COIL/LEFT SIDE ESSURE REVERSAL DISCOVERED RIGHT COIL LEFT"), DEVICE EXPULSION ("MIGRATION/EXPULSION OF ESSURE DEVICE/MIGRATION OF ESSURE (PIECE OF RIGHT SIDE COIL FOUND EMBEDDED IN MY UTERUS"), EMBEDDED DEVICE ("EXPULSION OF ESSURE DEVICE/MIGRATION OF ESSURE (PIECE OF RIGHT SIDE COIL FOUND EMBEDDED IN MY UTERUS") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 809011, 863581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "THEY HAD ISSUES PLACING ESSURE IN THE RIGHT SIDE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 5 ((B)(6) 2005, (B)(6) 2007, (B)(6) 2011, (B)(6) 2011, (B)(6) 2017) AND BACK SURGERY IN 2010. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVE NOS. CONCURRENT CONDITIONS INCLUDED CELLULITIS. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) SINCE 1-NOV-2017 FOR CONTRACEPTION AS WELL AS EUGYNON (ALESSE) IN 2011. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN 2011, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN LOWER ("RIGHT LOWER QUADRANT PAIN/LOWER RIGHT QUADRANT ABDOMINAL PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEPRESSION ("DEPRESSION/ANXIETY") AND PELVIC PAIN ("PAIN"). THE PATIENT WAS TREATED WITH IBUPROFEN (ADVIL), SURGERY (OPERATIVE LAPAROSCOPY, RIGHT SALPINGECTOMY HYSTEROSCOPIC RETRIEVAL OF FOREIGN OBJECT), SURGERY (OPERATIVE LAPAROSCOPY, RIGHT SALPINGECTOMY HYSTEROSCOPIC RETRIEVAL OF FOREIGN OBJECT), SURGERY (OPERATIVE LAPAROSCOPY, RIGHT SALPINGECTOMY HYSTEROSCOPIC RETRIEVAL OF FOREIGN OBJECT) AND SURGERY (OPERATIVE LAPAROSCOPY, RIGHT SALPINGECTOMY HYSTEROSCOPIC RETRIEVAL OF FOREIGN OBJECT). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, DEVICE EXPULSION, EMBEDDED DEVICE, GENITAL HAEMORRHAGE, DEPRESSION, PELVIC PAIN AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DEPRESSION, DEVICE BREAKAGE, DEVICE EXPULSION, EMBEDDED DEVICE, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE AND PELVIC PAIN TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ABDOMINAL PAIN LOWER, FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JUN-2018: PFS AND MR RECEIVED. EVENTS PER PFS: EXPULSION OF ESSURE DEVICE, MIGRATION OF ESSURE (PIECE OF RIGHT SIDE COIL FOUND EMBEDDED IN MY UTERUS), PAIN, PERFORATION (FALLOPIAN TUBE), OTHER INJURY/COMPLICATIONS (RIGHT PERFORATED TUBE), RIGHT LOWER QUADRANT PAIN WERE ADDED. 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.
NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION/FALLOPIAN TUBE PERFORATION/RIGHT PERFORATED TUBE/PIECE OF RIGHT COIL PERFORATED TUBE/PERFORATING RIGHT COIL PERITUBAL"), DEVICE BREAKAGE ("DEVICE FRACTURE/DEVICE BREAKAGE FOUND A PIECE OF RIGHT SIDE COIL/LEFT SIDE ESSURE REVERSAL DISCOVERED RIGHT COIL LEFT"), DEVICE EXPULSION ("MIGRATION/EXPULSION OF ESSURE DEVICE/MIGRATION OF ESSURE (PIECE OF RIGHT SIDE COIL FOUND EMBEDDED IN MY UTERUS"), EMBEDDED DEVICE ("EXPULSION OF ESSURE DEVICE/MIGRATION OF ESSURE (PIECE OF RIGHT SIDE COIL FOUND EMBEDDED IN MY UTERUS") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 809011, 863581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "THEY HAD ISSUES PLACING ESSURE IN THE RIGHT SIDE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 5 (08AUG2005, (B)(6) 2007, (B)(6) 2011, (B)(6) 2011, 2017) AND BACK SURGERY IN 2010. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVE NOS. CONCURRENT CONDITIONS INCLUDED CELLULITIS. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) SINCE (B)(6) 2017 FOR CONTRACEPTION AS WELL AS EUGYNON (ALESSE) IN 2011. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED.IN 2011, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN LOWER ("RIGHT LOWER QUADRANT PAIN/LOWER RIGHT QUADRANT ABDOMINAL PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEPRESSION ("DEPRESSION/ANXIETY") AND PELVIC PAIN ("PAIN"). THE PATIENT WAS TREATED WITH IBUPROFEN (ADVIL), SURGERY (OPERATIVE LAPAROSCOPY, RIGHT SALPINGECTOMY HYSTEROSCOPIC RETRIEVAL OF FOREIGN OBJECT). ESSURE WAS REMOVED IN (B)(6) 2016. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, DEVICE EXPULSION, EMBEDDED DEVICE, GENITAL HAEMORRHAGE, DEPRESSION, PELVIC PAIN AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DEPRESSION, DEVICE BREAKAGE, DEVICE EXPULSION, EMBEDDED DEVICE, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE AND PELVIC PAIN TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ABDOMINAL PAIN LOWER, FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE. BATCH NUMBER: 809011 EXP DATE:2013/12 MAN DATE:2010/12. BATCH NUMBER: 863581 EXP DATE:2014/05 MAN DATE:2011/05. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-AUG-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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("PERFORATION/FALLOPIAN TUBE PERFORATION/RIGHT PERFORATED TUBE/PIECE OF RIGHT COIL PERFORATED TUBE/PERFORATING RIGHT COIL PERITUBAL"), DEVICE BREAKAGE ("DEVICE FRACTURE/DEVICE BREAKAGE FOUND A PIECE OF RIGHT SIDE COIL/LEFT SIDE ESSURE REVERSAL DISCOVERED RIGHT COIL LEFT"), UTERINE PERFORATION ("EXPULSION OF ESSURE DEVICE/MIGRATION OF ESSURE (PIECE OF RIGHT SIDE COIL FOUND EMBEDDED IN MY UTERUS)/PERFORATION (UTERUS)") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 809011, 863581) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DIFFICULT TO USE "THEY HAD ISSUES PLACING ESSURE IN THE RIGHT SIDE". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTIGRAVIDA, PARITY 5 ((B)(6) 2005, (B)(6) 2007, (B)(6) 2011, (B)(6) 2011, (B)(6) 2017) AND BACK SURGERY IN 2010. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVE NOS. CONCURRENT CONDITIONS INCLUDED CELLULITIS. CONCOMITANT PRODUCTS INCLUDED LEVONORGESTREL (MIRENA) SINCE (B)(6) 2017 FOR CONTRACEPTION AS WELL AS EUGYNON (ALESSE) IN 2011. IN 2011, THE PATIENT EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). IN (B)(6) 2011, THE PATIENT EXPERIENCED ABDOMINAL PAIN LOWER ("RIGHT LOWER QUADRANT PAIN/LOWER RIGHT QUADRANT ABDOMINAL PAIN"). ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, 4 MONTHS 18 DAYS AFTER INSERTION OF ESSURE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2016, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEPRESSION ("DEPRESSION/ANXIETY") AND PELVIC PAIN ("PAIN"). THE PATIENT WAS TREATED WITH IBUPROFEN (ADVIL), SURGERY (OPERATIVE LAPAROSCOPY, RIGHT SALPINGECTOMY HYSTEROSCOPIC RETRIEVAL OF FOREIGN OBJECT), SURGERY (OPERATIVE LAPAROSCOPY, RIGHT SALPINGECTOMY HYSTEROSCOPIC RETRIEVAL OF FOREIGN OBJECT) AND SURGERY (RIGHT SALPINGECTOMY HYSTEROSCOPIC RETRIEVAL OF FOREIGN OBJECT). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE, UTERINE PERFORATION, GENITAL HAEMORRHAGE, DEPRESSION, PELVIC PAIN AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DEPRESSION, DEVICE BREAKAGE, FALLOPIAN TUBE PERFORATION, GENITAL HAEMORRHAGE, PELVIC PAIN AND UTERINE PERFORATION TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: ABDOMINAL PAIN LOWER, FALLOPIAN TUBE PERFORATION, DEVICE BREAKAGE. BATCH NUMBER: 809011, EXP DATE:2013/12, MAN DATE:2010/12. BATCH NUMBER: 863581, EXP DATE:2014/05, MAN DATE:2011/05. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-OCT-2018: PLAINTIFF FACT SHEET RECEIVED. PATIENT¿S DEMOGRAPHIC INFORMATION UPDATED. EVENT VERBATIM WAS UPDATED AS EXPULSION OF ESSURE DEVICE/MIGRATION OF ESSURE (PIECE OF RIGHT SIDE COIL FOUND EMBEDDED IN MY UTERUS)/PERFORATION (UTERUS)/EXPULSION OF ESSURE DEVICE AND PT WAS UPDATED FROM EMBEDDED DEVICE TO UTERINE PERFORATION. ESSURE REMOVAL UPDATED. 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PERFORATION ("PERFORATION"), DEVICE BREAKAGE ("DEVICE FRACTURE"), DEVICE DISLOCATION ("MIGRATION") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEPRESSION ("DEPRESSION/ANXIETY") AND PELVIC PAIN ("PAIN"). THE PATIENT WAS TREATED WITH SURGERY (PLAINTIFF HAD SURGERY TO REMOVE THE ESSURE IMPLANT.), SURGERY (PLAINTIFF HAD SURGERY TO REMOVE THE ESSURE IMPLANT.) AND SURGERY (PLAINTIFF HAD SURGERY TO REMOVE THE ESSURE IMPLANT.). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PERFORATION, DEVICE BREAKAGE, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, DEPRESSION AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN AND PERFORATION TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2017: AFTER INTERNAL REVIEW THE LISTEDNESS OF THE EVENT "PERFORATION" CHANGED FROM 'LISTED' TO 'UNLISTED'. PRODUCT PROBLEM BOX TICKED IN THE MED WATCH TAB. COMPANY CAUSALITY COMMENT : 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 |
|---|---|---|---|---|---|---|---|
| 813328 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 809011, 863581 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Other| R | ALESSE| ALESSE| ALESSE| MIRENA| MIRENA| MIRENA |