ESSURE
Report
- Report Number
- 2951250-2017-00523
- Event Type
- Malfunction
- Date Received
- February 16, 2017
- Report Date
- May 8, 2017
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- NURSE
Narratives
A (B)(6) FEMALE PATIENT WHO RECEIVED ESSURE (BATCH NO. HE011E3). ON (B)(6)2017, THE PATIENT STARTED ESSURE. FU QUESTIONNAIRE COMMENTS: PHYSICIAN STATED THERE WAS NO BREAKAGE, ON THE TIP OF THE IMPLANT THERE WAS A FUR. HE DID NOT KNOW WHAT IT WAS, SO THE IMPLANTATION WAS NOT MADE. PATIENT DID NOT HAVE ANY INJURY. NO DEVIATION OF INSERTION PROCEDURE OCCURRED. THE INSTRUCTIONS FOR USE WERE FOLLOWED. ACTION TAKEN WITH DEVICE: UNKNOWN. DIAGNOSTIC RESULTS: (B)(6) 2017 - HYSTEROSCOPY: EVENT DIAGNOSED ON (B)(6) 2017 (IMPLANTATION DATE). THERE WAS A FUR ON THE TIP OF IMPLANT. THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS CODED WITH THE SAME MEDRA PREFERRED TERM. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON (B)(6) 2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: DEVICE BREAKAGE. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 1532 CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THIS MEDDRA PT. QUALITY-SAFETY EVALUATION OF PTC: LOT NUMBER HE011E3 (EXPIRATION DATE 28-NOV-2018; PRODUCTION DATE 07-NOV-2015) SAMPLE NOT AVAILABLE. WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OR HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. BASED ON THE AVAILABLE INFORMATION A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. BASED ON THE PROVIDED INFORMATION THE DEFECT TYPE CORRESPONDS TO THE FOLLOWING MEDDRA LLT: DEVICE BREAKAGE. SINCE NO MEDICAL EVENTS WERE REPORTED AT THIS POINT IN TIME, THE ASSESSMENT OF A RELATIONSHIP WITH A QUALITY DEFECT, AS WELL AS, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES ARE NOT APPLICABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2017: QUALITY-SAFETY EVALUATION OF PTC WAS RECEIVED. ON (B)(6) 2017: FU BREAKAGE QUESTIONNAIRE. COMPANY CAUSALITY COMMENT: A FEMALE PATIENT HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND DURING THE INSERTION THEY NOTICED SOME KIND OF FIBER ON THE TOP OF THE CATHETER. WHEN UNLOADED CATHETER WAS TAKEN AWAY, THERE WAS NO FIBER ANYMORE. IN THIS PARTICULAR CASE, THE PHYSICIAN STATED UPON FOLLOW-UP THAT NO BREAKAGE OCCURRED (THERE WAS A FIBER/FUR ON THE TIP OF THE IMPLANT). HOWEVER, CONSIDERING THE NATURE OF THE REPORTED FIBER WAS UNKNOWN AND SINCE NO SAMPLE WAS RETURNED FOR ANALYSIS, COMPANY CONSIDERS A POSSIBLE DEVICE BREAKAGE (ANTICIPATED EVENT ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE) CANNOT BE RULED OUT. AS THIS EVENT OCCURRED AT TIME OF ESSURE INSERTION PROCEDURE, A CAUSAL RELATIONSHIP WITH THE SUSPECT DEVICE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS OTHER REPORTABLE INCIDENT DUE TO SUSPICION OF DEVICE BREAKAGE, AS ALTHOUGH IT DID NOT LEAD TO DEATH OR SERIOUS HEALTH DETERIORATION THIS MIGHT HAVE OCCURRED UNDER LESS FORTUNATE CIRCUMSTANCES. BASED ON THE AVAILABLE INFORMATION A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE.
THIS SPONTANEOUS CASE WAS REPORTED BY A NURSE AND DESCRIBES THE OCCURRENCE OF COMPLICATION OF DEVICE INSERTION ("COMPLICATION OF DEVICE INSERTION") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. HE011E3) INSERTED. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS "WRONG TECHNIQUE IN PRODUCT USAGE PROCESS" ON (B)(6) 2017. ON (B)(6) 2017, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED COMPLICATION OF DEVICE INSERTION. IT WAS UNKNOWN WHETHER ANY ACTION WAS TAKEN WITH ESSURE. AT THE TIME OF THE REPORT, THE COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR COMPLICATION OF DEVICE INSERTION WITH ESSURE. THE REPORTER COMMENTED: DURING THE INSERTION THEY NOTICED SOME KIND OF FIBER ON THE TOP OF THE CATHETER (LESS THAN 1 CM). THEY DECIDED NOT TO PUT THE CATHETER IN THE FALLOPIAN TUBE. WHEN UNLOADED CATHETER WAS TAKEN AWAY, THERE WAS NO FIBER ANYMORE. THE NURSE SAID THAT IT IS ALSO POSSIBLE THAT THE FIBER WAS IN THE UTERUS AND IT WAS STUCK FROM THERE TO THE CATHETER. THE OTHER IMPLANT´S INSERTION WAS SUCCESSFUL. FU QUESTIONNAIRE COMMENTS: PHYSICIAN STATED THERE WAS NO BREAKAGE, ON THE TIP OF THE IMPLANT THERE WAS A FUR. HE DID NOT KNOW WHAT IT WAS, SO THE IMPLANTATION WAS NOT MADE. PATIENT DID NOT HAVE ANY INJURY. NO DEVIATION OF INSERTION PROCEDURE OCCURRED. THE INSTRUCTIONS FOR USE WERE FOLLOWED. ACTION TAKEN WITH DEVICE: UNKNOWN. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS (B)(6). ON (B)(6) 2017 - HYSTEROSCOPY: EVENT DIAGNOSED ON (B)(6) 2017 (IMPLANTATION DATE). THERE WAS A FUR ON THE TIP OF IMPLANT. QUALITY-SAFETY EVALUATION OF PTC: LOT NUMBER HE011E3 (EXPIRATION DATE 28-NOV-2018; PRODUCTION DATE 07-NOV-2015) SINCE PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE ABLE TO CONDUCT AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. VISUAL INSPECTION WAS PERFORMED AND IT WAS CONFIRMED THAT ALL COMPONENTS ARE PRESENT, IFU STEPS WERE NOT INITIATED BY PHYSICIAN. THE MICRO-INSERT WAS STILL ATTACHED AND UNDEPLOYED FROM THE SYSTEM. BASED ON COMPLAINT AS REPORTED, WE DID NOT OBSERVE ANY DAMAGE ON THE MICRO INSERT (FIBERS), IN FACT AS PART OF THE INVESTIGATION PROCESS, IFU STEPS WERE COMPLETED BY RQU AND IT WAS CONFIRMED THAT MICRO-INSERT DEPLOYED AND DETACHED WITHOUT ANY INCONVENIENCE. WE WERE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. WE ALSO CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW FAILURE MODE FOR THE DEVICE. THE PTC INVESTIGATION WAS INITIATED AND THE OUTCOME OF THE INVESTIGATION RESULTED IN AN UNCONFIRMED QUALITY DEFECT. HOWEVER, A HANDLING ERROR WAS CONCLUDED AND THERE IS LIKELY A RELATIONSHIP BETWEEN THE COMPLAINT AND THE HANDLING ERROR. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 21-APR-2017: UPDATED QUALITY-SAFETY EVALUATION OF PTC WAS RECEIVED (SAMPLE WAS RETURNED FOR INVESTIGATION). EVENT WRONG TECHNIC IN PRODUCT USAGE PROCESS HAS BEEN ADDED. COMPANY CAUSALITY COMMENT: A FEMALE PATIENT HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND DURING THE INSERTION THEY NOTICED SOME KIND OF FIBER ON THE TOP OF THE CATHETER. DOCTOR DECIDED NOT TO PUT THE CATHETER IN THE FALLOPIAN TUBE, AND WHEN UNLOADED CATHETER WAS TAKEN AWAY, THERE WAS NO FIBER ANYMORE. THIS EVENT HAD INITIALLY BEEN INTERPRETED AS A SUSPICION OF DEVICE BREAKAGE. HOWEVER, UPON RECEIPT OF THE COMPLAINT SAMPLE, NO BREAKAGE OR DAMAGE WAS OBSERVED. THEREFORE, THE DEVICE BREAKAGE WAS RULED OUT AND THE CASE IS NO LONGER CONSIDERED TO BE A REPORTABLE INCIDENT. THE OUTCOME OF THE PRODUCT TECHNICAL INVESTIGATION RESULTED IN AN UNCONFIRMED QUALITY DEFECT.
THIS SPONTANEOUS CASE WAS REPORTED BY AN OTHER HEALTH PROFESSIONAL AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("SOME KIND OF FIBER ON THE TOP OF THE CATHETER. WHEN UNLOADED CATHETER WAS TAKEN AWAY, THERE WAS NO FIBER ANYMORE.") AND COMPLICATION OF DEVICE INSERTION ("COMPLICATION OF DEVICE INSERTION") IN A FEMALE PATIENT WHO RECEIVED ESSURE. ON AN UNKNOWN DATE, THE PATIENT STARTED ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE AND COMPLICATION OF DEVICE INSERTION. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE HAD RESOLVED AND THE COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEVICE BREAKAGE AND COMPLICATION OF DEVICE INSERTION WITH ESSURE. THE REPORTER COMMENTED: DURING THE INSERTION THEY NOTICED SOME KIND OF FIBER ON THE TOP OF THE CATHETER (LESS THAN 1 CM). THEY DECIDED NOT TO PUT THE CATHETER IN THE FALLOPIAN TUBE. WHEN UNLOADED CATHETER WAS TAKEN AWAY, THERE WAS NO FIBER ANYMORE. THE NURSE SAID THAT IT IS ALSO POSSIBLE THAT THE FIBER WAS IN THE UTERUS AND IT WAS STUCK FROM THERE TO THE CATHETER. THE OTHER IMPLANT´S INSERTION WAS SUCCESSFUL. COMPANY CAUSALITY COMMENT: A FEMALE PATIENT HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND DURING THE INSERTION THEY NOTICED SOME KIND OF FIBER ON THE TOP OF THE CATHETER. WHEN UNLOADED CATHETER WAS TAKEN AWAY, THERE WAS NO FIBER ANYMORE (SEEN AS SUSPICION OF DEVICE BREAKAGE). THE EVENT IS REGARDED AS ANTICIPATED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. IN THIS PARTICULAR CASE, THE SUSPICION OF BREAKAGE OCCURRED AT TIME OF ESSURE INSERTION PROCEDURE. THEREFORE, A CAUSAL RELATIONSHIP WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS OTHER REPORTABLE INCIDENT DUE TO THE DEVICE BREAKAGE, AS ALTHOUGH IT DID NOT LEAD TO DEATH OR SERIOUS HEALTH DETERIORATION THIS MIGHT HAVE OCCURRED UNDER LESS FORTUNATE CIRCUMSTANCES. FURTHER INFORMATION AND PRODUCT TECHNICAL ANALYSIS ARE BEING SOUGHT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 120596 | ESSURE | INSERT, TUBAL OCCLUSION | HHS | BAYER PHARMA AG | ESS305 | HE011E3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |