ESSURE
Report
- Report Number
- 2951250-2017-00599
- Event Type
- Injury
- Date Received
- February 20, 2017
- Date of Event
- January 4, 2017
- Report Date
- October 4, 2018
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A GYNECOLOGIST AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ("ESSURE WAS INTRAMYOMETRIAL AND SUB-SEROUS ON THE LEFT SIDE AT THE 3-MONTHS CONFIRMATION / SEROUS POSITION WITHOUT REAL PERFORATION") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. HE011F4) INSERTED. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1, SPONTANEOUS ABORTION, UTERINE DILATION AND CURETTAGE, CHOLECYSTECTOMY IN 2009, INCISIONAL HERNIA REPAIR IN 2013 AND CUSHING'S SYNDROME. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: HYDROCORTISONE 40MG QD AND PILLS. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2017, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY ON (B)(6) 2017). ESSURE WAS REMOVED ON (B)(6) 2017. IN 2017, THE EMBEDDED DEVICE HAD RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR EMBEDDED DEVICE WITH ESSURE. THE REPORTER COMMENTED: INSERTION PROCEDURE WAS PERFORMED WITH GENERAL ANAESTHESIA, POZZI PLACED WITHOUT MECHANICAL DILATION. THE INSERTION WAS EASY WITH VISUALIZATION OF TUBAL OSTIA. NO FLUID LOSS DURING HYSTEROSCOPY MORE THAN 1500CC. PROCEDURE DID NOT TAKE MORE THAN 20 MIN. NO COMPLAINT FROM PATIENT AFTER INSERTION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 22.7 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2017: UNILATERAL LEFT PERFORATION, SEROUS POSITION LAPAROSCOPY - ON (B)(6) 2017: LEFT COIL INTRAMYOMETRIAL AND VISIBLE IN SUBSEROUS ULTRASOUND SCAN - ON (B)(6) -2017: UNILATERAL LEFT PERFORATION, SEROUS POSITION (B)(6) 2017 - ECHOGRAPHY 3D, TRANSVAGINAL ECHOGRAPHY: OBSTRUCTION NOT CONFIRMED (BECAUSE OF ANOMALY OF POSITION OF LEFT ESSURE), CORRECT POSITION OF RIGHT ESSURE . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-OCT-2018: QUALITY SAFETY EVALUATION OF PTC. INCIDENT: 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 IN A SUPPLEMENTAL REPORT.
THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1, SPONTANEOUS ABORTION, UTERINE DILATION AND CURETTAGE, CHOLECYSTECTOMY IN 2009, HERNIA REPAIR IN 2013 AND CUSHING'S SYNDROME. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: HYDROCORTISONE 40MG QD AND PILLS. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2017, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY ON (B)(6) 2017). ESSURE WAS REMOVED ON (B)(6) 2017. IN 2017, THE EMBEDDED DEVICE HAD RESOLVED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS(B)(6). HYSTEROSALPINGOGRAM - ON (B)(6) 2017: UNILATERAL LEFT PERFORATION, SEROUS POSITION. LAPAROSCOPY - ON (B)(6) 2017: LEFT COIL INTRAMYOMETRIAL AND VISIBLE IN SUBSEROUS. ULTRASOUND SCAN - ON (B)(6) 2017: UNILATERAL LEFT PERFORATION, SEROUS POSITION. ON (B)(6) 2017 - ECHOGRAPHY 3D, TRANSVAGINAL ECHOGRAPHY: OBSTRUCTION NOT CONFIRMED. (BECAUSE OF ANOMALY OF POSITION OF LEFT ESSURE), CORRECT POSITION OF RIGHT ESSURE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2017: EVENT UPDATED. REMOVAL OF ESSURE PERFORMED. PATIENT INFORMATION, LAB DATA AND START / STOP DATE OF ESSURE ADDED. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS MEDICALLY CONFIRMED CASE REPORT REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND POOR POSITIONING ON THE LEFT SIDE WAS DIAGNOSED AT THE 3-MONTHS VERIFICATION. UPON FOLLOW-UP RECEIPT, IT WAS REPORTED THAT ESSURE WAS INTRAMYOMETRIAL AND SUB-SEROUS ON THE LEFT SIDE AT THE 3-MONTHS CONFIRMATION / SEROUS POSITION WITHOUT REAL PERFORATION, THUS EVENTS WAS REASSESSED AS EMBEDDED DEVICE. A LAPAROSCOPIC BILATERAL SALPINGECTOMY WAS PERFORMED. PATIENT IS RECOVERED. EMBEDDED DEVICE IS ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. IN THE PRESENT CASE THE EXACT TIME POINT AND MECHANISM OF THE EVENT IS UNKNOWN. THE INSERTION WAS EASY AND WITH NO COMPLAINTS FROM PATIENT. THE INCORRECT POSITIONING WAS DIAGNOSED APPROXIMATELY 3 MONTHS AFTER INSERTION. GIVEN THE NATURE OF THE REPORTED EVENT, CAUSALITY WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT DUE TO REQUIRED SURGICAL INTERVENTION. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENT CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENT IS A KNOWN POSSIBLE UNDESIRABLE EVENT AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO SIMILAR ADVERSE EVENT CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO THE REPORTED BATCH. NO FURTHER INFORMATION IS EXPECTED.
THE REPORTER COMMENTED: IMPLANT REMOVAL WAS PLANNED ON (B)(6) 2017. QUALITY-SAFETY EVALUATION OF PTC: BATCH NUMBER - HE011F4 - MANUFACTURING DATE: 11-NOV-2015 - EXPIRATION DATE: 28-NOV-2018. AS OF 06-MAR-2017, THE RQU HAS NOT RECEIVED RETURNED PRODUCT FOR THIS CASE. THIS CASE IS BEING PROCESSED AS IF NO PRODUCT WILL BE RETURNED. IF PRODUCT IS RECEIVED BY THE RQU IN THE FUTURE, A CHILD CASE WILL BE OPENED AND AN INVESTIGATION WILL BE COMPLETED ON THE RETURNED DEVICE. 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 OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENT CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENT IS A KNOWN POSSIBLE UNDESIRABLE EVENT AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO SIMILAR AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO THE REPORTED BATCH. NO SPECIFIC QUALITY ISSUE WAS DEFINED, THEREFORE NO MEDDRA LLT CAN BE PROVIDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-MAR-2017: QUALITY SAFETY EVALUATION OF PTC. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS MEDICALLY CONFIRMED CASE REPORT REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND POOR POSITIONING ON THE LEFT SIDE WAS DIAGNOSED AT THE 3-MONTHS VERIFICATION. ESSURE REMOVAL AND TUBAL LIGATION HAS BEEN SCHEDULED. THIS EVENT IS ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. IN THE PRESENT CASE THE EXACT TIME POINT AND MECHANISM OF THE EVENT IS UNKNOWN. NO DETAILS WERE PROVIDED ON THE INSERTION PROCEDURE. POOR POSITIONING WAS DIAGNOSED 3 MONTHS AFTER INSERTION. GIVEN THE NATURE OF THE REPORTED EVENT, CAUSALITY WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE DEVICE REMOVAL IS PLANNED. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENT CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENT IS A KNOWN POSSIBLE UNDESIRABLE EVENT AND NOT INDICATIVE OF A QUALITY DEFICIT PER SE. NO SIMILAR ADVERSE EVENT CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO THE REPORTED BATCH. FURTHER INFORMATION HAS BEEN REQUESTED.
THIS SPONTANEOUS CASE WAS REPORTED BY A GYNECOLOGIST/OBSTETRICIAN AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ("ESSURE WAS INTRAMYOMETRIAL AND SUB-SEROUS ON THE LEFT SIDE AT THE 3-MONTHS CONFIRMATION / SEROUS POSITION WITHOUT REAL PERFORATION") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. HE011F4) INSERTED. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA I, PARITY 1, SPONTANEOUS ABORTION, UTERINE DILATION AND CURETTAGE, CHOLECYSTECTOMY IN 2009, INCISIONAL HERNIA REPAIR IN 2013 AND CUSHING'S SYNDROME. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: HYDROCORTISONE 40MG QD AND PILLS. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2017, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL SALPINGECTOMY ON (B)(6) 2017). ESSURE WAS REMOVED ON (B)(6) 2017. IN 2017, THE EMBEDDED DEVICE HAD RESOLVED. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR EMBEDDED DEVICE WITH ESSURE. THE REPORTER COMMENTED: INSERTION PROCEDURE WAS PERFORMED WITH GENERAL ANAESTHESIA, (B)(6) PLACED WITHOUT MECHANICAL DILATION. THE INSERTION WAS EASY WITH VISUALIZATION OF TUBAL OSTIA. NO FLUID LOSS DURING HYSTEROSCOPY MORE THAN 1500CC. PROCEDURE DID NOT TAKE MORE THAN 20 MIN. NO COMPLAINT FROM PATIENT AFTER INSERTION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS (B)(6). HYSTEROSALPINGOGRAM - ON (B)(6) 2017: UNILATERAL LEFT PERFORATION, SEROUS POSITION LAPAROSCOPY - ON (B)(6) 2017: LEFT COIL INTRAMYOMETRIAL AND VISIBLE IN SUBSEROUS ULTRASOUND SCAN - ON (B)(6) 2017: UNILATERAL LEFT PERFORATION, SEROUS POSITION (B)(6) 2017 - ECHOGRAPHY 3D, TRANSVAGINAL ECHOGRAPHY: OBSTRUCTION NOT CONFIRMED (BECAUSE OF ANOMALY OF POSITION OF LEFT ESSURE), CORRECT POSITION OF RIGHT ESSURE THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS CODED WITH THE SAME MEDDRA PREFERRED TERM. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 05-APR-2017 FOR THE FOLLOWING MEDDRA PREFERRED TERMS: EMBEDDED DEVICE. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 325 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: BATCH NUMBER - HE011F4 - MANUFACTURING DATE: 11-NOV-2015 - EXPIRATION DATE: 28-NOV-2018 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 OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. THE REPORTED MEDICAL EVENT IS NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. THE REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT REVEAL ANY RELEVANT DEFICIENCIES OR ANY REASON TO SUSPECT A QUALITY DEFECT. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER INVESTIGATION THEREFORE THE COMPLAINT COULD NOT BE EVALUATED IN GREATER DETAIL. NO SIMILAR AE CASE REPORTS WERE IDENTIFIED FOR THE REPORTED BATCH. THE TECHNICAL ASSESSMENT CONCLUDED A QUALITY DEFECT WAS NOT CONFIRMED BUT CONSIDERED PLAUSIBLE. AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENT CANNOT BE TOTALLY EXCLUDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-MAY-2017: UPDATED QUALITY SAFETY EVALUATION OF PTC. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS MEDICALLY CONFIRMED CASE REPORT REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND POOR POSITIONING ON THE LEFT SIDE WAS DIAGNOSED AT THE 3-MONTHS VERIFICATION. UPON FOLLOW-UP RECEIPT, IT WAS REPORTED THAT ESSURE WAS INTRAMYOMETRIAL AND SUB-SEROUS ON THE LEFT SIDE AT THE 3-MONTHS CONFIRMATION / SEROUS POSITION WITHOUT REAL PERFORATION, THUS EVENTS WAS REASSESSED AS EMBEDDED DEVICE. A LAPAROSCOPIC BILATERAL SALPINGECTOMY WAS PERFORMED. PATIENT IS RECOVERED. EMBEDDED DEVICE IS ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. IN THE PRESENT CASE THE EXACT TIME POINT AND MECHANISM OF THE EVENT IS UNKNOWN. THE INSERTION WAS EASY AND WITH NO COMPLAINTS FROM PATIENT. THE INCORRECT POSITIONING WAS DIAGNOSED APPROXIMATELY 3 MONTHS AFTER INSERTION. GIVEN THE NATURE OF THE REPORTED EVENT, CAUSALITY WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT DUE TO REQUIRED SURGICAL INTERVENTION. ACCORDING TO THE UPDATED PRODUCT TECHNICAL ANALYSIS, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. NO FURTHER INFORMATION IS EXPECTED.
THIS SPONTANEOUS CASE WAS REPORTED BY A PHYSICIAN AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("POOR POSITIONING ON THE LEFT SIDE AT THE 3-MONTHS VERIFICATION") IN A (B)(6) FEMALE PATIENT WHO RECEIVED ESSURE. IN (B)(6) 2016, THE PATIENT STARTED ESSURE. IN (B)(6) 2017, THE PATIENT WAS DIAGNOSED WITH DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND CLINICALLY SIGNIFICANT/INTERVENTION REQUIRED). ESSURE REMOVAL WAS SCHEDULED/ TUBAL LIGATION HAS BEEN SCHEDULED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR DEVICE DISLOCATION WITH ESSURE. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS MEDICALLY CONFIRMED CASE REPORT REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND POOR POSITIONING ON THE LEFT SIDE WAS DIAGNOSED AT THE 3-MONTHS VERIFICATION. ESSURE REMOVAL AND TUBAL LIGATION HAS BEEN SCHEDULED. THIS EVENT IS ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. IN THE PRESENT CASE THE EXACT TIME POINT AND MECHANISM OF THE EVENT IS UNKNOWN. NO DETAILS WERE PROVIDED ON THE INSERTION PROCEDURE. POOR POSITIONING WAS DIAGNOSED 3 MONTHS AFTER INSERTION. GIVEN THE NATURE OF THE REPORTED EVENT, CAUSALITY WITH ESSURE CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE DEVICE REMOVAL IS PLANNED. A PRODUCT TECHNICAL ANALYSIS IS EXPECTED, AND FURTHER INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 125308 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | HE011F4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Other| R |