ESSURE
Report
- Report Number
- 2951250-2019-09172
- Event Type
- Injury
- Date Received
- October 1, 2019
- Report Date
- August 27, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') AND UTERINE PERFORATION ('APPARENT UTERINE PERFORATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841533) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "NOVA SURE ATTEMPTED--CAVITY CHECK FAILED, PROCEDURE ABORTED" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO CONFIRMATION TEST". ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND POST PROCEDURAL COMPLICATION ("REMOVAL CAUSED SMALL DIVOT IN MYOMETRIUM"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY USING DA VINCI ROBOT). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, UTERINE PERFORATION AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR UTERINE PERFORATION WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, PELVIC PAIN AND POST PROCEDURAL COMPLICATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION DATE- (B)(6) 2012 AND (B)(6) 2011. PLAINTIFFS RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN. PER MR: (B)(6) 2011: ESSURE INSERTION DETAILS: HYSTEROSCOPY DONE AND TUBAL OS LOCATED. ESSURE DEVICE INSERTED THROUGH PORT AND DEPLOYED IN TUBE WITHOUT INCIDENT. 3 COILS VISUALIZED. OPPOSITE AS LOCATED, ESSURE DEVICE INSERTED AND WOULD NOT DEPLOY APPROPRIATELY REMOVAL CAUSED A SMALL DIVOT IN MYOMETRIUM. THE OSTIA COULD NOT THEN BE CANNULATED-· PT TOLERATED WELL. PER MR: (B)(6) 2011 (RIGHT SIDE ESSURE INSERTION DETAILS): HYSTEROSCOPY DONE AND TUBAL OS LOCATED. ESSURE DEVICE INSERTED THROUGH PORT AND DEPLOYED IN TUBE WITHOUT INCIDENT 1 COILS VISUALIZED. NOVA SURE ATTEMPTED--CAVITY CHECK FAILED, PROCEDURE ABORTED. FINDINGS: APPARENT UTERINE PERFORATION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORD: "PERFORATION, MEDICAL DEVICE MONITORING ERROR AND POST PROCEDURAL COMPLICATION". MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-AUG-2020: MEDICAL RECORDS RECEIVED. EVENTS "UTERINE PERFORATION, MEDICAL DEVICE MONITORING ERROR AND POST PROCEDURAL COMPLICATION WERE ADDED. ESSURE LOT NUMBER WAS ADDED. THIS CASE IS MEDICALLY CONFIRMED. REPORTERS WERE ADDED. SURGERY UPDATED. 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 PELVIC PAIN ('PELVIC PAIN') AND UTERINE PERFORATION ('APPARENT UTERINE PERFORATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841533) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "NOVA SURE ATTEMPTED--CAVITY CHECK FAILED, PROCEDURE ABORTED" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO CONFIRMATION TEST". ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND POST PROCEDURAL COMPLICATION ("REMOVAL CAUSED SMALL DIVOT IN MYOMETRIUM"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY USING DA VINCI ROBOT). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN, UTERINE PERFORATION AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR UTERINE PERFORATION WITH ESSURE. THE REPORTER CONSIDERED ABDOMINAL PAIN, PELVIC PAIN AND POST PROCEDURAL COMPLICATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION DATE-(B)(6) 2012 AND (B)(6) 2011. PLAINTIFFS RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN. PER MR: (B)(6) 2011: ESSURE INSERTION DETAILS: HYSTEROSCOPY DONE AND TUBAL OS LOCATED. ESSURE DEVICE INSERTED THROUGH PORT AND DEPLOYED IN TUBE WITHOUT INCIDENT. 3 COILS VISUALIZED. OPPOSITE AS LOCATED, ESSURE DEVICE INSERTED AND WOULD NOT DEPLOY APPROPRIATELY REMOVAL CAUSED A SMALL DIVOT IN MYOMETRIUM. THE OSTIA COULD NOT THEN BE CANNULATED-· PT TOLERATED WELL. PER MR: (B)(6) 2011 (RIGHT SIDE ESSURE INSERTION DETAILS): HYSTEROSCOPY DONE AND TUBAL OS LOCATED. ESSURE DEVICE INSERTED THROUGH PORT AND DEPLOYED IN TUBE WITHOUT INCIDENT 1 COILS VISUALIZED. NOVA SURE ATTEMPTED--CAVITY CHECK FAILED, PROCEDURE ABORTED. FINDINGS: APPARENT UTERINE PERFORATION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORD: "PERFORATION, MEDICAL DEVICE MONITORING ERROR AND POST PROCEDURAL COMPLICATION". QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-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 PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO CONFIRMATION TEST". ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABDOMINAL PAIN ("ABDOMINAL PAIN"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (PARTIAL)). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY NOTED IN ESSURE INSERTION DATE-(B)(6) 2012 AND (B)(6)2011. PLAINTIFFS RECEIVED TREATMENT FOR PELVIC PAIN, ABDOMINAL PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-SEP-2019: PLAINTIFF FACT SHEET WAS RECEIVED. PREVIOUSLY REPORTED EVENT INJURY WAS REPLACED WITH NEW EVENTS: PELVIC PAIN, ABDOMINAL PAIN, SHE DID NOT UNDERGO CONFIRMATION TEST. REPORTER INFORMATION, DATE OF BIRTH, ESSURE REMOVAL DATE WERE ADDED. ESSURE INSERTION DATE WERE UPDATED. DEVICE CATEGORY CHANGED FROM DEVICE OTHER EVENT TO INCIDENT. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 935027 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841533 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |