ESSURE
Report
- Report Number
- 2951250-2023-01953
- Event Type
- Injury
- Date Received
- May 11, 2023
- Date of Event
- January 1, 2021
- Report Date
- November 18, 2023
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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 34 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2019, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2021, 731 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 (SURGICAL REMOVAL OF COILS). 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. 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: 09-JUN-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 34 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF MENSES PAINFUL, PELVIC PAIN, ABDOMINAL PAIN AND OVERWEIGHT. ON (B)(6) 2019, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2021, 731 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 (LAPAROSCOPIC BILATERAL SALPINGECTOMY,INCLUDING REMOVAL OF ESSURE COIL). 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: SHE HAD ESSURE PLACED IN 2016 A MARYLAND GRASPER REMAINING PIECE OF THE ESSURE COIL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX: 25.781 KG/SQM. [PATHOLOGY TEST] ON (B)(6) 2020: CLINICAL HISTORY DESIRED STERILIZATION. FINAL PATHOLOGIC DIAGNOSIS: FALLOPIAN TUBES, BILATERAL SALPINGECTOMY: BENIGN TUBES WITH COMPLETE CROSS SECTION. GROSS DESCRIPTION: RECEIVED IN FORMALIN LABELED WITH THE PATIENT'S NAME, DOB AND BILATERAL FALLOPIAN TUBES, CONSISTS OF BILATERAL SALPINGECTOMY SPECIMEN FEATURING 7.0 X 0.5 OM PORTIONS OF FIMBRIATED FALLOPIAN TUBE AND ONE METALLIC COILED PROSTHETIC DEVICE (3.0 CAM). 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: 31-OCT-2023: REPORTER AND PATIENT INFORMATION, MEDICAL HISTORY, LAB DATA, INDICATION, AND NON DRUG TREATMNET ADDED. 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 34 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2019, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2021, (B)(6) 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 (SURGICAL REMOVAL OF COILS). 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. 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: 19-MAY-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 34 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2019, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2021, 731 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 (SURGICAL REMOVAL OF COILS). 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. 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 |
|---|---|---|---|---|---|---|---|
| 915936 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Female | Required Intervention |