ESSURE
Report
- Report Number
- 2951250-2023-01714
- Event Type
- Injury
- Date Received
- March 29, 2023
- Date of Event
- October 1, 2021
- Report Date
- January 4, 2024
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("DEVICE BREAKAGE") IN A 32 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 863570) FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF NICKEL ALLERGY IN 2021. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ESSURE WAS REMOVED ON (B)(6) 2021. AN UNKNOWN TIME LATER SHE EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE FROM THE UTERINE CORNUA. SALPINGECTOMY, HYSTEROSCOPY). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE BREAKAGE TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: AS A RESULT OF ESSURE, THIS PLAINTIFF SUFFERED FROM SEVERE AND PERMANENT INJURIES. 5 COILS SHOWING OUT OF THE RIGHT OSTIA; 4 COILS SHOWING IN THE LEFT OSTIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [PATHOLOGY TEST] ON (B)(6) 2021: SPECIMEN SUBMITTED: LEFT TUBE. RIGHT TUBE WITH PARTIAL ESSURE COIL. LEFT TUBE ESSURE COIL. RIGHT TUBE ESSURE COIL. PRE-DIAGNOSIS (HISTORY): BLEEDING, ALLERGY TO ESSURE COILS. FINAL DIAGNOSIS (MICROSCOPIC): LEFT TUBE: COMPLETE CROSS-SECTION, BENIGN FALLOPIAN TUBE. RIGHT TUBE WITH PARTIAL ESSURE COIL: COMPLETE CROSS-SECTION, BENIGN FALLOPIAN TUBE. LEFT TUBE ESSURE COIL: FOREIGN BODY (ESSURE COIL). RIGHT TUBE ESSURE COIL: FOREIGN BODY (ESSURE COIL). GROSS DESCRIPTION: RIGHT TUBE WITH PARTIAL ESSURE COIL. IT CONTAINS A 6.0 CM IN LENGTH BY 0.5 CM IN DIAMETER, TORTUOUS, RED-GRAY, FIMBRIATED FALLOPIAN TUBE SEGMENT. THERE IS A 0.6 X 0.5 CM DISRUPTED AREA. LEFT TUBE ESSURE COIL. IT CONTAINS A 12 CM IN LENGTH UNRAVELED ESSURE COIL. RIGHT TUBE ESSURE COIL. IT CONTAINS A 4.7 CM UNRAVELED ESSURE COIL. "CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: DEVICE BREAKAGE 10012575." THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 18-SEP-2023: MEDICAL DEVICE REMOVAL UPDATED TO DEVICE BREAKAGE EVENT REPORTER INFORMATION,PATIENT INFORMATION, MEDICAL HISTORY, LAB DATA, LOT NO, DRUG STOP DATE, NON DRUG TREATMENT 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 DEVICE BREAKAGE ("DEVICE BREAKAGE") IN A 32 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 863570) FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF NICKEL ALLERGY IN 2021. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ESSURE WAS REMOVED ON (B)(6) 2021. AN UNKNOWN TIME LATER SHE EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE FROM THE UTERINE CORNUA.SALPINGECTOMY,HYSTEROSCOPY.). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE BREAKAGE TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: AS A RESULT OF ESSURE, THIS PLAINTIFF SUFFERED FROM SEVERE AND PERMANENT INJURIES. 5 COILS SHOWING OUT OF THE RIGHT OSTIA 4 COILS SHOWING IN THE LEFT OSTIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [PATHOLOGY TEST] ON (B)(6) 2021: SPECIMEN SUBMITTED: 1.LEFT TUBE 2.RIGHT TUBE WITH PARTIAL ESSURE COIL 3. LEFT TUBE ESSURE COIL 4. RIGHT TUBE ESSURE COIL PRE-DAIGNOSIS (HISTORY): BLEEDING, ALLERGY TO ESSURE COILS. FINAL DIAGNOSIS (MICROSCOPIC): 1. LEFT TUBE: - COMPLETE CROSS-SECTION, BENIGN FALLOPIAN TUBE. 2. RIGHT TUBE WITH PARTIAL ESSURE COIL: - COMPLETE CROSS-SECTION, BENIGN FALLOPIAN TUBE. 3. LEFT TUBE ESSURE COIL: - FOREIGN BODY (ESSURE COIL). 4. RIGHT TUBE ESSURE COIL: - FOREIGN BODY (ESSURE COIL). GROSS DESCRIPTION: 1.RIGHT TUBE WITH PARTIAL ESSURE COIL. IT CONTAINS A 6.0 CM IN LENGTH BY 0.5 CM IN DIAMETER, TORTUOUS, RED-GRAY, FIMBRIATED FALLOPIAN TUBE SEGMENT. THERE IS A 0.6 X 0.5 CM DISRUPTED AREA. 2. LEFT TUBE ESSURE COIL. IT CONTAINS A 12 CM IN LENGTH UNRAVELED ESSURE COIL. 3.RIGHT TUBE ESSURE COIL. IT CONTAINS A 4.7 CM UNRAVELED ESSURE COIL. LOT NUMBER: 863570; MANUFACTURE DATE: 2011-11; EXPIRATION DATE: 2014-11. 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: 04-JAN-2024: 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 FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2021, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE). 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: AS A RESULT OF ESSURE, THIS PLAINTIFF SUFFERED FROM SEVERE AND PERMANENT INJURIES. 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: 24-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 AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. IN (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2021 SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED ON AN UNKNOWN DAY OF THE SAME MONTH. THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE). 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: AS A RESULT OF ESSURE, THIS PLAINTIFF SUFFERED FROM SEVERE AND PERMANENT INJURIES. 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 |
|---|---|---|---|---|---|---|---|
| 591854 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 863570 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Female | Required Intervention |