ESSURE
Report
- Report Number
- 2951250-2022-00090
- Event Type
- Injury
- Date Received
- February 4, 2022
- Date of Event
- June 3, 2021
- Report Date
- January 17, 2024
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE BELOW REPORT WAS RECEIVED BY HEALTH AUTHORITY ANSM (REFERENCE NUMBER: (B)(4)) ON 02-FEB-2022. THE MOST RECENT INFORMATION WAS RECEIVED ON 18-FEB-2022. THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ("MIGRATION IN UTERUS"), BLADDER PERFORATION ("BLADDER TEARING, MULTIPLE BLADDER PERFORATIONS DUE TO BLADDER AND UTERUS ADHESIONS") AND PROCEDURAL HAEMORRHAGE ("HAEMORRHAGES DURING REMOVAL WITH BLOOD TRANSFUSIONS") IN A 51 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 810885). ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: COMPLICATION OF DEVICE REMOVAL ("COMPLICATION OF DEVICE REMOVAL" ON (B)(6) 2021) AND URETERAL STENT OCCLUSION ("URGENT REPEAT SURGERY DUE TO OCCLUDED DOUBLE-J URETER STENT ENDANGERING KIDNEY" ON (B)(6) 2021). THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. AN UNKNOWN TIME LATER SHE EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERION INTERVENTION REQUIRED), UTERINE ADHESIONS ("UTERUS ADHESIONS") AND PELVIC PAIN ("PELVIC PAIN"). THE PATIENT WAS TREATED WITH SURGERY (UTERUS REMOVAL VIA LAPAROTOMY ON (B)(6) 2021). ON (B)(6) 2021, 3616 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED BLADDER PERFORATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED), PROCEDURAL HAEMORRHAGE (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH BLOOD TRANSFUSION, AUXILIARY PRODUCTS AS WELL AS SURGERY (6HRS LAPAROTOMY, URINARY CATHETER 6 WEEKS, DOUBLE-J STENT 3 MONTHS, REPEAT SURGERY FOR BLOCKED STENT). NO CAUSALITY ASSESSMENT WAS RECEIVED FOR ESSURE WITH REGARD TO BLADDER PERFORATION, UTERINE ADHESIONS, PROCEDURAL HAEMORRHAGE, DEVICE EXPULSION OR PELVIC PAIN. THE REPORTER COMMENTED: UTERUS REMOVAL VIA LAPAROTOMY WITH SIGNIFICANT SURGICAL COMPLICATIONS: BLADDER TEARING, REIMPLANTATION OF THE URETER AND MULTIPLE BLADDER PERFORATIONS DUE TO BLADDER AND UTERUS ADHESIONS. PLACEMENT OF DOUBLE-J STENTS. HAEMORRHAGES DURING REMOVAL WITH BLOOD TRANSFUSIONS 6 HOURS OF SURGERY. A URINARY CATHETER FOR 6 WEEKS AND DOUBLE-J STENT FOR 3 MONTHS. URGENT REPEAT SURGERY DUE TO OCCLUDED DOUBLE-J URETER STENT ENDANGERING KIDNEY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 68 KG. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. THE FOLLOWING AMENDMENT WAS MADE: UPON INTERNAL REVIEW EVENTS MIGRATION IN UTERUS AND PELVIC PAIN WERE ADDED. EVENTS DELETED: URETERAL STENT INSERTION AND URGENT REPEAT SURGERY BECAUSE THEY WERE SURGERY SPECIFICATIONS FOR EVENT BLADDER PERFORATIONS, EVENT BLADDER INJURY REMOVED SINCE SPECIFIED BY EVENT BLADDER PERFORATION, EVENT RENAL INJURY REMOVED SINCE NOT REPORTED AS EVENT (REPORTED THAT ACTION TAKEN TO PREVENT RENAL INJURY), EVENT NUMEROUS POST-OPERATIVE COMPLICATIONS WAS REMOVED, AS THOSE HAVE BEEN SPECIFIED. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (ANSM, REFERENCE NUMBER: (B)(4)) ON 02-FEB-2022. THE MOST RECENT INFORMATION WAS RECEIVED ON 18-FEB-2022. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BLADDER PERFORATION ('MULTIPLE BLADDER PERFORATIONS DUE TO BLADDER AND UTERUS ADHESIONS'), PROCEDURAL HAEMORRHAGE ('HAEMORRHAGES DURING REMOVAL WITH BLOOD TRANSFUSIONS'), URETERAL STENT INSERTION ('A URINARY CATHETER FOR 6 WEEKS AND DOUBLE-J STENT FOR 3 MONTHS') AND VESICOURETERAL REFLUX SURGERY ('URGENT REPEAT SURGERY DUE TO OCCLUDED DOUBLE-J URETER STENT ENDANGERING KIDNEY') IN A 51-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810885) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE OCCLUSION "URGENT REPEAT SURGERY DUE TO OCCLUDED DOUBLE-J URETER STENT ENDANGERING KIDNEY" ON (B)(6) 2021. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2021, THE PATIENT EXPERIENCED BLADDER PERFORATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED), PROCEDURAL HAEMORRHAGE (SERIOUSNESS CRITERION INTERVENTION REQUIRED), COMPLICATION OF DEVICE REMOVAL ("COMPLICATION OF DEVICE REMOVAL"), BLADDER INJURY ("BLADDER TEARING"), UTERINE ADHESIONS ("UTERUS ADHESIONS"), RENAL INJURY ("URGENT REPEAT SURGERY DUE TO OCCLUDED DOUBLE-J URETER STENT ENDANGERING KIDNEY") AND POST PROCEDURAL COMPLICATION ("NUMEROUS POST-OPERATIVE COMPLICATIONS") AND UNDERWENT URETERAL STENT INSERTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND VESICOURETERAL REFLUX SURGERY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 9 YEARS 10 MONTHS AFTER INSERTION AND 1 DAY AFTER REMOVAL OF ESSURE. THE PATIENT WAS TREATED WITH BLOOD TRANSFUSION, AUXILIARY PRODUCTS AND SURGERY (6 HOURS OF SURGERY, SURGERY AND UTERUS REMOVAL VIA LAPAROTOMY WITH SIGNIFICANT SURGICAL COMPLICATIONS). AT THE TIME OF THE REPORT, THE PROCEDURAL HAEMORRHAGE, URETERAL STENT INSERTION, VESICOURETERAL REFLUX SURGERY, COMPLICATION OF DEVICE REMOVAL, BLADDER INJURY, RENAL INJURY AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR BLADDER INJURY, BLADDER PERFORATION, COMPLICATION OF DEVICE REMOVAL, POST PROCEDURAL COMPLICATION, PROCEDURAL HAEMORRHAGE, RENAL INJURY, URETERAL STENT INSERTION, UTERINE ADHESIONS AND VESICOURETERAL REFLUX SURGERY WITH ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 68 KGS. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-FEB-2022: QUALITY SAFETY EVALUATION OF PTC. 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 CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY ((B)(6), REFERENCE NUMBER: (B)(4)) ON 02-FEB-2022. THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF BLADDER PERFORATION ('MULTIPLE BLADDER PERFORATIONS DUE TO BLADDER AND UTERUS ADHESIONS'), PROCEDURAL HAEMORRHAGE ('HAEMORRHAGES DURING REMOVAL WITH BLOOD TRANSFUSIONS'), URETERAL STENT INSERTION ('A URINARY CATHETER FOR 6 WEEKS AND DOUBLE-J STENT FOR 3 MONTHS') AND VESICOURETERAL REFLUX SURGERY ('URGENT REPEAT SURGERY DUE TO OCCLUDED DOUBLE-J URETER STENT ENDANGERING KIDNEY') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 810885) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2021, THE PATIENT EXPERIENCED BLADDER PERFORATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED), PROCEDURAL HAEMORRHAGE (SERIOUSNESS CRITERION INTERVENTION REQUIRED), COMPLICATION OF DEVICE REMOVAL ("COMPLICATION OF DEVICE REMOVAL"), PROCEDURAL COMPLICATION ("BLADDER TEARING"), UTERINE ADHESIONS ("UTERUS ADHESIONS"), COMPLICATION ASSOCIATED WITH DEVICE ("URGENT REPEAT SURGERY DUE TO OCCLUDED DOUBLE-J URETER STENT ENDANGERING KIDNEY"), RENAL INJURY ("URGENT REPEAT SURGERY DUE TO OCCLUDED DOUBLE-J URETER STENT ENDANGERING KIDNEY") AND POST PROCEDURAL COMPLICATION ("NUMEROUS POST-OPERATIVE COMPLICATIONS") AND UNDERWENT URETERAL STENT INSERTION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND VESICOURETERAL REFLUX SURGERY (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 9 YEARS 10 MONTHS AFTER INSERTION AND 1 DAY AFTER REMOVAL OF ESSURE. THE PATIENT WAS TREATED WITH BLOOD TRANSFUSION, AUXILIARY PRODUCTS AND SURGERY (6 HOURS OF SURGERY, SURGERY AND UTERUS REMOVAL VIA LAPAROTOMY WITH SIGNIFICANT SURGICAL COMPLICATIONS). AT THE TIME OF THE REPORT, THE PROCEDURAL HAEMORRHAGE, URETERAL STENT INSERTION, VESICOURETERAL REFLUX SURGERY, COMPLICATION OF DEVICE REMOVAL, PROCEDURAL COMPLICATION, COMPLICATION ASSOCIATED WITH DEVICE, RENAL INJURY AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR BLADDER PERFORATION, COMPLICATION ASSOCIATED WITH DEVICE, COMPLICATION OF DEVICE REMOVAL, POST PROCEDURAL COMPLICATION, PROCEDURAL COMPLICATION, PROCEDURAL HAEMORRHAGE, RENAL INJURY, URETERAL STENT INSERTION, UTERINE ADHESIONS AND VESICOURETERAL REFLUX SURGERY WITH ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE (B)(6). 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1594152 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 810885 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Female | Required Intervention |