ESSURE
Report
- Report Number
- 2951250-2018-01902
- Event Type
- Injury
- Date Received
- April 20, 2018
- Date of Event
- June 24, 2013
- Report Date
- September 10, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- 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 ("RIGHT FALLOPIAN TUBE PERFORATION"), DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE, SURGERY APPENDECTOMY DUE TO COIL MIGRATION AND CLOSE TO APPENDIX.") AND CYST RUPTURE ("RUPTURED CYST") IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B11728) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ACUTE APPENDICITIS, APPENDECTOMY, HEADACHE, SYNCOPE, BIPOLAR DISORDER, ASTHMA, DEPRESSION, ANXIETY, LOOP ELECTROSURGICAL EXCISION PROCEDURE AND CERVICAL DYSPLASIA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ESGIC, VYVANSE AND NIFEDIPINE. CONCOMITANT PRODUCTS INCLUDED SUMATRIPTAN (IMITREX) FROM 2014 TO 2017 FOR MIGRAINE. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), PYREXIA ("FEVER") AND MUSCULOSKELETAL PAIN ("SHOULDER PAIN"). ON (B)(6) 2015, THE PATIENT EXPERIENCED CYST RUPTURE (SERIOUSNESS CRITERIA HOSPITALIZATION AND MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY AND SURGERY (APPENDECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE DISLOCATION, CYST RUPTURE AND PYREXIA OUTCOME WAS UNKNOWN, THE ABDOMINAL PAIN WAS RESOLVING AND THE MUSCULOSKELETAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, CYST RUPTURE, DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, MUSCULOSKELETAL PAIN AND PYREXIA TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-MAY-2018: PLAINTIFF FACT SHEET RECEIVED. NEW REPORTERS ADDED. PATIENT DEMOGRAPHIC INFORMATION AND PATIENT RELEVANT HISTORY ADDED. EVENTS FOUND IN ABDOMEN DURING SURGERY, RUPTURED CYST, FEVER, SHOULDER PAIN, ABDOMINAL PAIN 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 ("RIGHT FALLOPIAN TUBE PERFORATION"), DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE, SURGERY APPENDECTOMY DUE TO COIL MIGRATION AND CLOSE TO APPENDIX.") AND CYST RUPTURE ("RUPTURED CYST") IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B11728) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ACUTE APPENDICITIS, APPENDECTOMY, HEADACHE, SYNCOPE, BIPOLAR DISORDER, ASTHMA, DEPRESSION, ANXIETY, LOOP ELECTROSURGICAL EXCISION PROCEDURE AND CERVICAL DYSPLASIA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ESGIC, VYVANSE AND NIFEDIPINE. CONCOMITANT PRODUCTS INCLUDED SUMATRIPTAN (IMITREX) FROM 2014 TO 2017 FOR MIGRAINE. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), PYREXIA ("FEVER") AND MUSCULOSKELETAL PAIN ("SHOULDER PAIN"). ON (B)(6) 2015, THE PATIENT EXPERIENCED CYST RUPTURE (SERIOUSNESS CRITERIA HOSPITALIZATION AND MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED REPRODUCTIVE TRACT DISORDER ("REPRODUCTIVE SYSTEM DISORDER"). THE PATIENT WAS TREATED WITH SURGERY AND SURGERY (APPENDECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE DISLOCATION, CYST RUPTURE, PYREXIA AND REPRODUCTIVE TRACT DISORDER OUTCOME WAS UNKNOWN, THE ABDOMINAL PAIN WAS RESOLVING AND THE MUSCULOSKELETAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, CYST RUPTURE, DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, MUSCULOSKELETAL PAIN, PYREXIA AND REPRODUCTIVE TRACT DISORDER TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-SEP-2018: PLAINTIFF FACT SHEET RECEIVED: REPRODUCTIVE SYSTEM DISORDER EVENT WAS 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 ("RIGHT FALLOPIAN TUBE PERFORATION"), DEVICE DISLOCATION ("MIGRATION OF ESSURE DEVICE, SURGERY APPENDECTOMY DUE TO COIL MIGRATION AND CLOSE TO APPENDIX.") AND CYST RUPTURE ("RUPTURED CYST") IN A 23-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B11728) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ACUTE APPENDICITIS, APPENDECTOMY, HEADACHE, SYNCOPE, BIPOLAR DISORDER, ASTHMA, DEPRESSION, ANXIETY, LOOP ELECTROSURGICAL EXCISION PROCEDURE AND CERVICAL DYSPLASIA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ESGIC, VYVANSE AND NIFEDIPINE. CONCOMITANT PRODUCTS INCLUDED SUMATRIPTAN (IMITREX) FROM 2014 TO 2017 FOR MIGRAINE. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN AND DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON (B)(6) 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("ABDOMINAL PAIN"), PYREXIA ("FEVER") AND MUSCULOSKELETAL PAIN ("SHOULDER PAIN"). ON (B)(6) 2015, THE PATIENT EXPERIENCED CYST RUPTURE (SERIOUSNESS CRITERIA HOSPITALIZATION AND MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY AND SURGERY (APPENDECTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE DISLOCATION, CYST RUPTURE AND PYREXIA OUTCOME WAS UNKNOWN, THE ABDOMINAL PAIN WAS RESOLVING AND THE MUSCULOSKELETAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, CYST RUPTURE, DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, MUSCULOSKELETAL PAIN AND PYREXIA TO BE RELATED TO ESSURE. 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 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 FALLOPIAN TUBE PERFORATION ("RIGHT FALLOPIAN TUBE PERFORATION") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B11728) INSERTED FOR FEMALE STERILISATION. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED ACUTE APPENDICITIS, APPENDECTOMY, HEADACHE, SYNCOPE, BIPOLAR DISORDER, ASTHMA, DEPRESSION AND ANXIETY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ESGIC, VYVANSE AND NIFEDIPINE. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN. THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED FALLOPIAN TUBE PERFORATION TO BE RELATED TO ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-FEB-2018: PLAINTIFF FACT SHEET WAS RECEIVED. EVENTS ADDED FROM PFS- FALLOPIAN TUBE PERFORATION. LOT NUMBER, HISTORICAL CONDITION, HISTORICAL DRUG WERE ADDED. ESSURE LEGAL MANUFACTURE HAS CHANGED FROM BAYER HEALTHCARE, LLC, MILPITAS TO BAYER PHARMA AG, BERLIN, AND THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP TO A PREVIOUS REPORT SUBMITTED UNDER THE FORMER LEGAL MANUFACTURER. REPORT TYPE ¿INITIAL¿ INDICATES HERE INITIAL SUBMISSION BY THE NEW LEGAL MANUFACTURER ONLY. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 288824 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | B11728 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Hospitalization| O| R | IMITREX| IMITREX| IMITREX |