ESSURE
Report
- Report Number
- 2951250-2020-01144
- Event Type
- Injury
- Date Received
- February 10, 2020
- Report Date
- August 17, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER, AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('THE ESSURE DEVICE WAS REMOVED IN 2 SEGMENT'), DEVICE MIGRATION ('MIGRATION'), UTERINE PERFORATION ('PERFORATED UTERUS/PATENT FALLOPIAN TUBE'), FALLOPIAN TUBE PERFORATION ('PERFORATED TUBE'), EMBEDDED DEVICE ('LEFT ESSURE DEVICE EMBEDDED IN UTERINE SEROSA') AND DEVICE DISLOCATION INTO ABDOMINAL CAVITY ('ESSURE IN PELVIC CAVITY'). IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 904753), INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: PATENT LEFT FALLOPIAN TUBE WITH LEFT ESSURE DEVICE OUTSIDE THE FALLOPIAN TUBE WITHIN THE LEFT PELVIS. 2. SATISFACTORY POSITION OF RIGHT ESSURE DEVICE WITH RIGHT FALLOPIAN TUBE OCCLUSION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE MIGRATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION INTO ABDOMINAL CAVITY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PELVIC PAIN ("LOT OF PAIN"). AND WAS FOUND TO HAVE WHITE BLOOD CELL COUNT INCREASED ("INFECTION/ INCREASE WHITE BLOOD CELL"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED., HYSTERECTOMY AND ESSURE REMOVED.). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE MIGRATION, UTERINE PERFORATION, EMBEDDED DEVICE, DEVICE DISLOCATION INTO ABDOMINAL CAVITY, PELVIC PAIN AND WHITE BLOOD CELL COUNT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE BREAKAGE, DEVICE MIGRATION, EMBEDDED DEVICE, FALLOPIAN TUBE PERFORATION, PELVIC PAIN, UTERINE PERFORATION, WHITE BLOOD CELL COUNT INCREASED AND DEVICE DISLOCATION INTO ABDOMINAL CAVITY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE DEVICE WAS REMOVED. HOWEVER, THERE MAY BE A SMALL SEGMENT REMAINING WITHIN THE UTERINE MYOMETRIUM. THE ANTERIOR ABDOMINAL WALL, WHERE THE ESSURE WAS EMBEDDED WAS ALSO COAGULATED WITH THE GYRUS AND NEED TO BE HEMOSTATIC. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM: ON (B)(6) 2012, SATISFACTORY POSITION OF ESSURE DEVICE. WHITE BLOOD CELL COUNT: ON AN UNKNOWN DATE, NORMAL. BUT SLIGHTLY INCREASED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS SOCIAL MEDIA RECORD: ESSURE MIGRATION, INCREASED WHITE BLOOD CELL COUNT, UTERINE PERFORATION, FALLOPIAN TUBE PERFORATION, PELVIC PAIN. LOT NUMBER#: 904753, MANUFACTURE DATE: 2011-10, EXPIRATION DATE: 2014-10. QUALITY SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-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 DEVICE BREAKAGE ('THE ESSURE DEVICE WAS REMOVED IN 2 SEGMENT .'), DEVICE DISLOCATION ('MIGRATION'), UTERINE PERFORATION ('PERFORATED UTERUS /PATENT FALLOPIAN TUBE.'), FALLOPIAN TUBE PERFORATION ('PERFORATED TUBE') AND EMBEDDED DEVICE ('LEFT ESSURE DEVICE EMBEDDED IN UTERINE SEROSA AND') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 904753) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: PATENT LEFT FALLOPIAN TUBE WITH LEFT ESSURE DEVICE OUTSIDE THE FALLOPIAN TUBE WITHIN THE LEFT PELVIS. 2. SATISFACTORY POSITION OF RIGHT ESSURE DEVICE WITH RIGHT FALLOPIAN TUBE OCCLUSION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION ("ESSURE IN PELVIC CAVITY,") AND PELVIC PAIN ("LOT OF PAIN") AND WAS FOUND TO HAVE WHITE BLOOD CELL COUNT INCREASED ("INFECTION/ INCREASE WHITE BLOOD CELL"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVED., HYSTERECTOMY AND ESSURE REMOVED.). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE DISLOCATION, UTERINE PERFORATION, EMBEDDED DEVICE, DEVICE EXPULSION, PELVIC PAIN AND WHITE BLOOD CELL COUNT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE BREAKAGE, DEVICE DISLOCATION, DEVICE EXPULSION, EMBEDDED DEVICE, FALLOPIAN TUBE PERFORATION, PELVIC PAIN, UTERINE PERFORATION AND WHITE BLOOD CELL COUNT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE DEVICE WAS REMOVED. HOWEVER, THERE MAY BE A SMALL SEGMENT REMAINING WITHIN THE UTERINE MYOMETRIUM. THE ANTERIOR ABDOMINAL WALL WHERE THE ESSURE WAS EMBEDDED WAS ALSO COAGULATED WITH THE GYRUS AND NEED TO BE HEMOSTATIC. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: SATISFACTORY POSITION OF ESSURE DEVICE. WHITE BLOOD CELL COUNT - ON AN UNKNOWN DATE: NORMAL BUT SLIGHTLY INCREASED. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS SOCIAL MEDIA RECORD: ESSURE MIGRATION, INCREASED WHITE BLOOD CELL COUNT, UTERINE PERFORATION, FALLOPIAN TUBE PERFORATION, PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: PIF RECEIVED: LAB TEST ADDED, PATIENT'S DOB ADDED, LOT NO AND REPORTER INFORMATION ADDED. NEW EVENT DEVICE EXPULSION , DEVICE EMBEDDED AND DEVICE BREAKAGE ADDED. 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 DEVICE DISLOCATION ('MIGRATION'), UTERINE PERFORATION ('PERFORATED UTERUS') AND FALLOPIAN TUBE PERFORATION ('PERFORATED TUBE') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND PELVIC PAIN ("LOT OF PAIN") AND WAS FOUND TO HAVE WHITE BLOOD CELL COUNT INCREASED ("INFECTION/ INCREASE WHITE BLOOD CELL"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, UTERINE PERFORATION, PELVIC PAIN AND WHITE BLOOD CELL COUNT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, PELVIC PAIN, UTERINE PERFORATION AND WHITE BLOOD CELL COUNT INCREASED TO BE RELATED TO ESSURE. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS SOCIAL MEDIA RECORD: ESSURE MIGRATION, INCREASED WHITE BLOOD CELL COUNT, UTERINE PERFORATION, FALLOPIAN TUBE PERFORATION, PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 20-MAR-2020: SOCIAL MEDIA RECEIVED: EVENTS ADDED- PERFORATED TUBES, PERFORATED UTERUS AND LOT OF PAIN. REPORTER INFORMATION ADDED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND WAS FOUND TO HAVE WHITE BLOOD CELL COUNT INCREASED ("INFECTION/ INCREASE WHITE BLOOD CELL"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION AND WHITE BLOOD CELL COUNT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION AND WHITE BLOOD CELL COUNT INCREASED TO BE RELATED TO ESSURE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS SOCIAL MEDIA RECORD: ESSURE MIGRATION" AND INCREASED WHITE BLOOD CELL COUNT. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-FEB-2020: QUALITY-SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. IN (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND WAS FOUND TO HAVE WHITE BLOOD CELL COUNT INCREASED ("INFECTION/INCREASE WHITE BLOOD CELL"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY). AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION AND WHITE BLOOD CELL COUNT INCREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION AND WHITE BLOOD CELL COUNT INCREASED TO BE RELATED TO ESSURE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE WAS DESCRIBED IN PATIENTS SOCIAL MEDIA RECORD: ESSURE MIGRATION" AND INCREASED WHITE BLOOD CELL COUNT QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 150583 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 904753 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |