ESSURE
Report
- Report Number
- 2951250-2023-02281
- Event Type
- Injury
- Date Received
- May 23, 2023
- Date of Event
- February 25, 2009
- 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
- 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 EXPULSION ("APPROXIMATELY 50% OF INNER COIL SEEN EXTENDING FROM EXTREME LATERAL ASPECT OF CORNUA") AND DEVICE DISLOCATION ("ESSURE COIL OCCUPYING THE ENDOMETRIAL CAVITY") IN A 52 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 627307) FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF SNEEZING, COUGHING, MORBID OBESITY, MYOFASCIAL PAIN SYNDROME, PELVIC PAIN, ENDOMETRIOSIS, FIBROMYALGIA, PARITY 2, GRAVIDA II, MORBID OBESITY, HYPOTHYROIDISM, HEADACHE AND CHEST PAIN. THE PATIENT HAD A FAMILY HISTORY OF BREAST CANCER, KNEE OPERATION, BREAST CANCER, OVARIAN CANCER AND COLON CANCER. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2009, 55 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ON (B)(6) 2020 SHE EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY - UTERUS). ESSURE WAS REMOVED ON (B)(6) 2021. THE REPORTER CONSIDERED DEVICE DISLOCATION TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [HYSTEROSALPINGOGRAM] (DATE UNKNOWN): MIDPORTION OF THE INNER COIL IS AT THE EXTREME LATERAL MARGIN OF THE CORNUA WITH APPROXIMATELY 50% OF THE INNER COIL NOTED LATERAL TO THE CORNUA ON THE RIGHT. LEFT COIL DEMONSTRATES NORMAL POSITIONING. NO CONTRAST BEYOND THE COILS NOTED WITHIN THE TUBES. NO ENDOMETRIAL ABNORMALITIES. IMPRESSION: 1. LEFT TUBAL OCCLUSION WITH ACCEPTABLE COIL PLACEMENT. 2. APPROXIMATELY 50% OF INNER COIL SEEN EXTENDING FROM EXTREME LATERAL ASPECT OF CORNUA. SURGEONS CORRELATION RECOMMENDED [PATHOLOGY TEST] (DATE UNKNOWN): ADENOMYOMA ESSURE DEVICE. PATIENT REPORTS HER PELVIC PAIN IS WELL CONTROLLED. [ULTRASOUND SCAN] ON (B)(6) 2020: ESSURE DEVICE IS DISPLACED AND IS WITHIN THE ENDOMETRIAL CAVITY COMPLETELY THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 13-OCT-2023: MR RECEIVED : LOT NUMBER ADDED, REPORTERS INFORMATION PATIENT MEDICAL HISTORY AND SURGICAL PATHOLOGY REPORTS WERE ADDED. EVENT IS UPDATED TO "PARTIAL EXPULSION OF DEVICE". 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 AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 52 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2021, 4383 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 (HYSTERECTOMY - UTERUS). 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: 15-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 (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF SEVERAL EPISODES OF DEVICE EXPULSION ("APPROXIMATELY 50% OF INNER COIL SEEN EXTENDING FROM EXTREME LATERAL ASPECT OF CORNUA" AND "ESSURE COIL OCCUPYING THE ENDOMETRIAL CAVITY") IN A 52 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 627307) FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF SNEEZING, COUGHING, MORBID OBESITY, MYOFASCIAL PAIN SYNDROME, PELVIC PAIN, ENDOMETRIOSIS, FIBROMYALGIA, PARITY 2, GRAVIDA II, MORBID OBESITY, HYPOTHYROIDISM, HEADACHE AND CHEST PAIN. THE PATIENT HAD A FAMILY HISTORY OF BREAST CANCER, KNEE OPERATION, BREAST CANCER, OVARIAN CANCER AND COLON CANCER. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2009, 55 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED A FIRST EPISODE OF DEVICE EXPULSION (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ON (B)(6) 2020 SHE EXPERIENCED A SECOND EPISODE OF DEVICE EXPULSION (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED ON (B)(6) 2021. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY - UTERUS). THE REPORTER CONSIDERED THE FIRST EPISODE OF DEVICE EXPULSION AND THE SECOND EPISODE OF DEVICE EXPULSION TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [HYSTEROSALPINGOGRAM] (DATE UNKNOWN): MIDPORTION OF THE INNER COIL IS AT THE EXTREME LATERAL MARGIN OF THE CORNUA WITH APPROXIMATELY 50% OF THE INNER COIL NOTED LATERAL TO THE CORNUA ON THE RIGHT. LEFT COIL DEMONSTRATES NORMAL POSITIONING. NO CONTRAST BEYOND THE COILS NOTED WITHIN THE TUBES. NO ENDOMETRIAL ABNORMALITIES. IMPRESSION: 1. LEFT TUBAL OCCLUSION WITH ACCEPTABLE COIL PLACEMENT. 2. APPROXIMATELY 50% OF INNER COIL SEEN EXTENDING FROM EXTREME LATERAL ASPECT OF CORNUA. SURGEONS CORRELATION RECOMMENDED [PATHOLOGY TEST] (DATE UNKNOWN): ADENOMYOMA ESSURE DEVICE. PATIENT REPORTS HER PELVIC PAIN IS WELL CONTROLLED. [ULTRASOUND SCAN] ON (B)(6) 2020: ESSURE DEVICE IS DISPLACED AND IS WITHIN THE ENDOMETRIAL CAVITY COMPLETELY LOT NUMBER: 627307, MANUFACTURE DATE: 2008-05, EXPIRATION DATE: 2011-05. 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: 25-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 52 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2021, 4383 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 (HYSTERECTOMY - UTERUS). 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 WAS 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 |
|---|---|---|---|---|---|---|---|
| 218654 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 627307 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Female | Required Intervention |