ESSURE
Report
- Report Number
- 2951250-2023-01244
- Event Type
- Injury
- Date Received
- March 14, 2023
- Date of Event
- May 12, 2017
- Report Date
- January 26, 2024
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 37 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2017, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2017, 88 DAYS AFTER ESSURE INSERTION, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL SURGERY). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: MORE THAN ONE ESSURE RELATED SURGERY-NO. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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 AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 10-APR-2023: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ("METALLIC COILS EMBEDDED INTO THE MYOMETRIUM") IN A 37 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO: D19664) FOR FEMALE STERILISATION. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR ("MEDICAL DEVICE MONITORING ERROR" ON 13-FEB-2017). THE PATIENT HAD A MEDICAL HISTORY OF MENORRHAGIA, ANEMIA AND OVARIAN CYST. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: FERROUS SULFATE, ENOXAPARIN, IBUPROFEN AND ACETAMINOPHEN. ON (B)(6) 2017, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2017, 88 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC ASSISTED HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND OVARIAN CYSTECTOMY). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED EMBEDDED DEVICE TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: MORE THAN ONE ESSURE RELATED SURGERY-NO. FAILED ABLATION FOR MENORRHAGIA AND CHRONIC ANEMIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 88 KG. [PATHOLOGY TEST] (DATE UNKNOWN): FINAL PATHOLOGIC DIAGNOSES A. RIGHT OVARIAN CYST WALL: BENIGN FUNCTIONAL FOLLICLE CYST B. UTERUS, CERVIX, BILATERAL FALLOPIAN TUBES: 180 G UTERUS CERVIX, NABOTHIAN CYSTS, OTHERWISE, UNREMARKABLE ADENOMYOSIS OF UTERUS, EXTENSIVE ENDOMETRIUM, FOCAL RESIDUAL INACTIVE ENDOMETRIUM, FIBROUS SCARRING BILATERAL FIMBRIATED FALLOPIAN TUBES WITH ATTACHED TO BENIGN SIMPLE PARATUBAL CYSTS 0.3 AND 0.8 CM OTHERWISE, NEGATIVE FOR DIAGNOSTIC ABNORMALITY. SPECIMEN (S) A: RIGHT OVARIAN CYST WALL B: UTERUS, CERVIX AND BILATERAL FALLOPIAN TUBES. PROCEDURE ROBOTIC ASSISTED HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND CYSTOSCOPY PREOPERATIVE DIAGNOSIS ANEMIA AND MENORRHAGIA. GROSS DESCRIPTION: BOTH CORNUS' ARE REMARKABLE FOR METALLIC COILS EMBEDDED INTO THE MYOMETRIUM, AT THE ATTACHMENT SITE OF THE FALLOPIAN TUBES. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS EMBEDDED DEVICE (10074498) AND MEDICAL DEVICE MONITORING ERROR (10077672). THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 31-OCT-2023: MEDICAL RECORD RECEIVED. MEDICAL HISTORY & LAB DATA ADDED INCLUDING PATHOLOGY TEST .REPORTER INFORMATION ADDED .LOT NUMBER AND EXPIRY DATE ADDED .NON DRUG TREATMENT UPDATED. EVENTS EMBEDDED DEVICE AND MEDICAL DEVICE MONITORING ERROR ADDED. 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 ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ("METALLIC COILS EMBEDDED INTO THE MYOMETRIUM") IN A 37 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. D19664) FOR FEMALE STERILISATION. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR ("MEDICAL DEVICE MONITORING ERROR" ON (B)(6) 2017). THE PATIENT HAD A MEDICAL HISTORY OF MENORRHAGIA, ANEMIA AND OVARIAN CYST. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: FERROUS SULFATE, ENOXAPARIN, IBUPROFEN AND ACETAMINOPHEN. ON (B)(6) 2017, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2017, 88 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (ROBOTIC ASSISTED HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND OVARIAN CYSTECTOMY.). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED EMBEDDED DEVICE TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: MORE THAN ONE ESSURE RELATED SURGERY-NO. FAILED ABLATION FOR MENORRHAGIA AND CHRONIC ANEMIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY WEIGHT WAS REPORTED TO BE 88 KG. [PATHOLOGY TEST] (DATE UNKNOWN): FINAL PATHOLOGIC DIAGNOSES A. RIGHT OVARIAN CYST WALL: BENIGN FUNCTIONAL FOLLICLE CYST B. UTERUS, CERVIX, BILATERAL FALLOPIAN TUBES: -180 G UTERUS CERVIX, NABOTHIAN CYSTS, OTHERWISE, UNREMARKABLE ADENOMYOSIS OF UTERUS, EXTENSIVE - ENDOMETRIUM, FOCAL RESIDUAL INACTIVE ENDOMETRIUM, FIBROUS SCARRING BILATERAL FIMBRIATED FALLOPIAN TUBES WITH ATTACHED TO BENIGN SIMPLE PARATUBAL CYSTS 0.3 AND 0.8 CM OTHERWISE, NEGATIVE FOR DIAGNOSTIC ABNORMALITY. SPECIMEN (S) A: RIGHT OVARIAN CYST WALL B: UTERUS, CERVIX AND BILATERAL FALLOPIAN TUBES. PROCEDURE ROBOTIC ASSISTED HYSTERECTOMY WITH BILATERAL SALPINGECTOMY AND CYSTOSCOPY PREOPERATIVE DIAGNOSIS ANEMIA AND MENORRHAGIA GROSS DESCRIPTION: BOTH CORNUS' ARE REMARKABLE FOR METALLIC COILS EMBEDDED INTO THE MYOMETRIUM, AT THE ATTACHMENT SITE OF THE FALLOPIAN TUBES. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS EMBEDDED DEVICE (10074498) AND MEDICAL DEVICE MONITORING ERROR (10077672). 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 MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 26-JAN-2024: UPDATED 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 ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 37 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2017, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2017, 88 DAYS AFTER ESSURE INSERTION, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL SURGERY). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: MORE THAN ONE ESSURE RELATED SURGERY-NO. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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 AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1114836 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | D19664 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Female | Other| R |