ESSURE
Report
- Report Number
- 2951250-2016-00550
- Event Type
- Injury
- Date Received
- May 11, 2016
- Report Date
- November 22, 2017
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
QUALITY-SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT (PTC): RECEIVED ON 26-MAY-2016: GLOBAL PTC NUMBER: (B)(4). FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. FOR CASES WHERE AN INSERT IS REMOVED AT A LATER TIME AFTER INSERTION, WE TYPICALLY DO NOT CONDUCT AN INSPECTION OF THE INSERT. IN THIS CASE, NO PRODUCT WAS RETURNED. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. THE PTC INVESTIGATION WAS INITIATED AND THE OUTCOME OF THE ASSESSMENT RESULTED IN AN UNCONFIRMED QUALITY DEFECT. COMPANY CAUSALITY COMMENT: THIS CASE REPORT WAS RECEIVED FROM A LAWYER ON BEHALF OF A FEMALE PLAINTIFF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) REMOVED DUE TO COMPLICATIONS. THIS EVENT IS LISTED ACCORDING TO ESSURE'S REFERENCE SAFETY INFORMATION. THIS CASE WAS RECEIVED THROUGH A LEGAL CLAIM WHICH INCLUDED SEVERAL PLAINTIFFS AND THE ADVERSE EVENTS/COMPLICATIONS EACH INDIVIDUAL PLAINTIFF EXPERIENCED WERE NOT SPECIFIED. DESPITE OF THE LACK OF DETAILS FOR A COMPREHENSIVE CAUSALITY ASSESSMENT; CONSIDERING ESSURE REMOVAL WAS REQUIRED, CAUSALITY WITH THE SUSPECT DEVICE CANNOT BE EXCLUDED. THEREFORE, THIS CASE WAS REGARDED AS INCIDENT. THE PRODUCT TECHNICAL COMPLAINT ANALYSIS RESULTED IN AN UNCONFIRMED QUALITY DEFECT. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("DEVICE REMOVED") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B93674) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTI GRAVIDA, PARITY 1 AND ABORTION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: TORADOL, LIDOCAINE AND ATIVAN. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND COMPLICATION ASSOCIATED WITH DEVICE ("DEVICE COMPLICATION"). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE DEVICE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL AND COMPLICATION ASSOCIATED WITH DEVICE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED COMPLICATION ASSOCIATED WITH DEVICE AND MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BOTH TUBAL OSTIA WERE SEEN CLEARLY, GIVING THE EXPECTATION OF SUCCESSFUL BILATERAL PLACEMENT OF THE ESSURE MICRO-INSERTS. THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 1. SHE TOLERATED THE PROCEDURE: WELL, STATING SHE HAD ONLY MILD CRAMPS AT MOST. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST URINE - ON (B)(6) 2015: NEGATIVE. QUALITY-SAFETY EVALUATION OF PTC: FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. FOR CASES WHERE AN INSERT IS REMOVED AT A LATER TIME AFTER INSERTION, WE TYPICALLY DO NOT CONDUCT AN INSPECTION OF THE INSERT. IN THIS CASE, NO PRODUCT WAS RETURNED. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. THE PTC INVESTIGATION WAS INITIATED AND THE OUTCOME OF THE ASSESSMENT RESULTED IN AN UNCONFIRMED QUALITY DEFECT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-MAY-2017: LOT NUMBER, MEDICAL HISTORY AND INSERTION INFORMATION ADDED. COMPANY CAUSALITY COMMENT: THIS CASE REPORT WAS RECEIVED FROM A LAWYER ON BEHALF OF A FEMALE PLAINTIFF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) REMOVED DUE TO COMPLICATIONS. THIS EVENT IS LISTED ACCORDING TO ESSURE'S REFERENCE SAFETY INFORMATION. THIS CASE WAS RECEIVED THROUGH A LEGAL CLAIM WHICH INCLUDED SEVERAL PLAINTIFFS AND THE ADVERSE EVENTS/COMPLICATIONS EACH INDIVIDUAL PLAINTIFF EXPERIENCED WERE NOT SPECIFIED. DESPITE OF THE LACK OF DETAILS FOR A COMPREHENSIVE CAUSALITY ASSESSMENT; CONSIDERING ESSURE REMOVAL WAS REQUIRED, CAUSALITY WITH THE SUSPECT DEVICE CANNOT BE EXCLUDED. THEREFORE, THIS CASE WAS REGARDED AS INCIDENT. THE PRODUCT TECHNICAL COMPLAINT ANALYSIS RESULTED IN AN UNCONFIRMED QUALITY DEFECT. A PRODUCT TECHNICAL ANALYSIS UPDATE IS EXPECTED. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("DEVICE REMOVED") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTI GRAVIDA, PARITY 1 AND RECURRENT ABORTION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: TORADOL, LIDOCAINE AND ATIVAN. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND COMPLICATION ASSOCIATED WITH DEVICE ("DEVICE COMPLICATION"). THE PATIENT WAS TREATED WITH SURGERY (SURGERY TO REMOVE DEVICE). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL AND COMPLICATION ASSOCIATED WITH DEVICE OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED COMPLICATION ASSOCIATED WITH DEVICE AND MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BOTH TUBAL OSTIA WERE SEEN CLEARLY, GIVING THE EXPECTATION OF SUCCESSFUL BILATERAL PLACEMENT OF THE ESSURE MICRO-INSERTS. THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 1. SHE TOLERATED THE PROCEDURE: WELL, STATING SHE HAD ONLY MILD CRAMPS AT MOST. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST URINE - ON (B)(6) 2015: NEGATIVE. QUALITY-SAFETY EVALUATION OF PTC: FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. FOR CASES WHERE AN INSERT IS REMOVED AT A LATER TIME AFTER INSERTION, WE TYPICALLY DO NOT CONDUCT AN INSPECTION OF THE INSERT. IN THIS CASE, NO PRODUCT WAS RETURNED. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. THE PTC INVESTIGATION WAS INITIATED AND THE OUTCOME OF THE ASSESSMENT RESULTED IN AN UNCONFIRMED QUALITY DEFECT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2017: THE LOT NUMBER REPORTED FOR THIS CASE IS INVALID. COMPANY CAUSALITY COMMENT: 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 DEVICE DISLOCATION ("MIGRATION") AND GENITAL HAEMORRHAGE ("ABNORMAL BLEEDING") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B93674 (INVALID)) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED MULTI GRAVIDA, PARITY 1 AND RECURRENT ABORTION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: TORADOL, LIDOCAINE AND ATIVAN. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT) AND DYSPAREUNIA ("PAINFUL INTERCOURSE"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE DEVICE). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE AND DYSPAREUNIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, DYSPAREUNIA AND GENITAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: BOTH TUBAL OSTIA WERE SEEN CLEARLY, GIVING THE EXPECTATION OF SUCCESSFUL BILATERAL PLACEMENT OF THE ESSURE MICRO-INSERTS. THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY WAS 1. SHE TOLERATED THE PROCEDURE: WELL, STATING SHE HAD ONLY MILD CRAMPS AT MOST. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PREGNANCY TEST URINE ON (B)(6) 2015: NEGATIVE. FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. FOR CASES WHERE AN INSERT IS REMOVED AT A LATER TIME AFTER INSERTION, WE TYPICALLY DO NOT CONDUCT AN INSPECTION OF THE INSERT. IN THIS CASE, NO PRODUCT WAS RETURNED. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. THE PTC INVESTIGATION WAS INITIATED AND THE OUTCOME OF THE ASSESSMENT RESULTED IN AN UNCONFIRMED QUALITY DEFECT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-OCT-2017: LEGAL CLAIM RECEIVED, LAWYER ADDED. EVENTS DELETED: DEVICE REMOVED, DEVICE COMPLICATIONS. EVENTS ADDED: ABNORMAL BLEEDING, PAINFUL INTERCOURSE, MIGRATION, PAIN. ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF REPORTING, 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.
DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.
THIS IS A SPONTANEOUS CASE REPORT RECEIVED ON 15-APR-2016 FROM A LAWYER IN THE UNITED STATES, ON BEHALF OF A FEMALE PLAINTIFF OF UNSPECIFIED AGE IN UNITED STATES WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED FOR PERMANENT STERILIZATION. THE PLAINTIFF WAS IMPLANTED WITH ESSURE AND SUBSEQUENTLY HAD THE DEVICE REMOVED DUE TO COMPLICATIONS. COMPANY CAUSALITY COMMENT: THIS CASE REPORT WAS RECEIVED FROM A LAWYER ON BEHALF OF A FEMALE PLAINTIFF WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) REMOVED DUE TO COMPLICATIONS. THIS EVENT IS LISTED ACCORDING TO ESSURE'S REFERENCE SAFETY INFORMATION. THIS CASE WAS RECEIVED THROUGH A LEGAL CLAIM WHICH INCLUDED SEVERAL PLAINTIFFS AND THE ADVERSE EVENTS/COMPLICATIONS EACH INDIVIDUAL PLAINTIFF EXPERIENCED WERE NOT SPECIFIED. DESPITE OF THE LACK OF DETAILS FOR A COMPREHENSIVE CAUSALITY ASSESSMENT; CONSIDERING ESSURE REMOVAL WAS REQUIRED, CAUSALITY WITH THE SUSPECT DEVICE CANNOT BE EXCLUDED. THEREFORE, THIS CASE WAS REGARDED AS INCIDENT. A PRODUCT TECHNICAL ANALYSIS IS BEING SOUGHT. FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301933 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | B93674 (INVALID) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |