ESSURE
Report
- Report Number
- 2951250-2018-02899
- Event Type
- Injury
- Date Received
- June 29, 2018
- Report Date
- July 31, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('ESSURE DISLOCATION / MIGRATION'), GASTROINTESTINAL INJURY ('THE RIGHT ESSURE WAS NOTED TO BE PERFORATED THROUGH THE CORNUA INTO THE ABDOMINAL CAVITY') AND ENDOMETRIAL ABLATION ('ENDOMETRIAL ABLATION / NOVASURE ABLATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 678820 (R), 20222097 (L)) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GASTROINTESTINAL INJURY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL DISTENSION ("I STILL GET BLOATED LIKE BEFORE") AND PELVIC PAIN ("PELVIC PAIN ") AND UNDERWENT ENDOMETRIAL ABLATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY AND ENDO ABLATION FROM 9-15). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GASTROINTESTINAL INJURY, ENDOMETRIAL ABLATION AND PELVIC PAIN OUTCOME WAS UNKNOWN AND THE ABDOMINAL DISTENSION HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, DEVICE DISLOCATION, ENDOMETRIAL ABLATION, GASTROINTESTINAL INJURY AND PELVIC PAIN TO BE RELATED TO ESSURE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN SOCIAL MEDIA: MEDICAL DEVICE REMOVAL AND ABDOMINAL DISTENSION. LOT NUMBER: 20222097. MANUFACTURE DATE: 2009-10. EXPIRATION DATE: 2012-10. LOT NUMBER: 678820. MANUFACTURE DATE: 2009-10. EXPIRATION DATE: 2012-10. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-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 DEVICE DISLOCATION ('ESSURE DISLOCATION / MIGRATION'), GASTROINTESTINAL INJURY ('THE RIGHT ESSURE WAS NOTED TO BE PERFORATED THROUGH THE CORNUA INTO THE ABDOMINAL CAVITY') AND ENDOMETRIAL ABLATION ('ENDOMETRIAL ABLATION / NOVASURE ABLATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 678820 (R), 20222097 (L)) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GASTROINTESTINAL INJURY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL DISTENSION ("I STILL GET BLOATED LIKE BEFORE") AND PELVIC PAIN ("PELVIC PAIN ") AND UNDERWENT ENDOMETRIAL ABLATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY AND ENDO ABLATION FROM 9-15). ESSURE WAS REMOVED ON (B)(6) 2016. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GASTROINTESTINAL INJURY, ENDOMETRIAL ABLATION AND PELVIC PAIN OUTCOME WAS UNKNOWN AND THE ABDOMINAL DISTENSION HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, DEVICE DISLOCATION, ENDOMETRIAL ABLATION, GASTROINTESTINAL INJURY AND PELVIC PAIN TO BE RELATED TO ESSURE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN SOCIAL MEDIA: MEDICAL DEVICE REMOVAL AND ABDOMINAL DISTENSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-JAN-2020: FUP 3 AND FUP 4 PROCESSED TOGETHER. FUP 4 - PIF RECEIVED. REPORTER INFORMATION WERE ADDED. DATE OF INSERTION WERE ADDED. FUP 3 - MEDICAL RECORDS RECEIVED. LOT NUMBER ADDED. EVENT MEDICAL DEVICE REMOVAL UPDATED TO DEVICE DISLOCATION, THE RIGHT ESSURE WAS NOTED TO BE PERFORATED THROUGH THE CORNUA INTO THE ABDOMINAL CAVITY. EVENTS ADDED FROM PFS- PELVIC PAIN. DATE OF REMOVAL WERE ADDED. REPORTER INFORMATION WERE 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 MEDICAL DEVICE REMOVAL ("I HAD A BILATERAL SALPINGECTOMY") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN SOCIAL MEDIA: MEDICAL DEVICE REMOVAL. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 2-NOV-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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('I HAD A BILATERAL SALPINGECTOMY') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED ABDOMINAL DISTENSION ("I STILL GET BLOATED LIKE BEFORE"). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN AND THE ABDOMINAL DISTENSION HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION AND MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN SOCIAL MEDIA: MEDICAL DEVICE REMOVAL AND ABDOMINAL DISTENSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-OCT-2019: SOCIAL MEDIA RECEIVED : FOLLOWING EVENT WAS ADDED - I STILL GET BLOATED LIKE BEFORE. REPORTER INFORMATION ADDED. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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 ("I HAD A BILATERAL SALPINGECTOMY") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN SOCIAL MEDIA: MEDICAL DEVICE REMOVAL 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 |
|---|---|---|---|---|---|---|---|
| 493496 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 678820 (R), 20222097 (L) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |