ESSURE
Report
- Report Number
- 2951250-2023-02291
- Event Type
- Injury
- Date Received
- May 23, 2023
- Date of Event
- May 13, 2016
- Report Date
- January 25, 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 EMBEDDED DEVICE ("ESSURE+REMOVAL / SHINY SILVER MEDICAL DEVICE EMBEDDED ABOUT THE PROXIMAL TO MID LUMEN.") IN A 25 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. D06941) FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF SCOLIOSIS, PNEUMONIA, ABRUPTIO PLACENTAE, GASTROESOPHAGEAL REFLUX DISEASE, ECZEMA, CHICKENPOX, CHRONIC CERVICITIS, ENDOMETRIOSIS, MIGRAINE, BIPOLAR DISORDER, ANXIETY DISORDER, CESAREAN SECTION, PARITY 4, MULTI GRAVIDA, PERINEAL PAIN, DYSMENORRHEA, ABDOMINAL PAIN, MENORRHAGIA, MENSTRUATION ABNORMAL, PSYCHIATRIC DISORDER NOS, DEPRESSION, , ADENOMYOSIS AND PELVIC PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: DICLEGIS, TYLENOL, INDOMETHACIN AGILA AND ALPRAZOLAM. THE PATIENT HAD A FAMILY HISTORY OF OVARIAN CANCER. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) -2016, 143 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED EMBEDDED DEVICE (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 EMBEDDED DEVICE TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: DISCREPANCY NOTED : INSERTION DATE AS PER ARGUS (B)(6) 2015 AS PER MR (B)(6) 2015 DISCREPANCY NOTED : REMOVAL DATE AS PER ARGUS (B)(6) 2015 AS PER MR (B)(6) 2016. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [PATHOLOGY TEST] ON (B)(6) 2016: SPECIMEN RECEIVED: CERVIX, UTERUS, BILATERAL TUBES. CLINICAL HISTORY: ENDOMETRIOSIS, ADENOMYOSIS, PELVIC PAIN, STERILIZATION FINAL DIAGNOSIS: CERVIX, UTERUS, BILATERAL TUBES : SEROSA: FIBROUS ADHESIONS. CERVIX: MILD CHRONIC ENDOCERVICITIS, DEFINITIVE ECTOCERVICAL MUCOSA IS NOT IDENTIFIED. ENDOMETRIUM: DISORDERED PROLIFERATIVE TYPE. MYOMETRIUM: UNREMARKABLE. RIGHT FALLOPIAN TUBE: STATUS POST COIL PLACEMENT. LEFT FALLOPIAN TUBE: STATUS POST COIL PLACEMENT. [PREGNANCY TEST] ON (B)(6) 2015: NEGATIVE [ULTRASOUND SCAN VAGINA] ON (B)(6) 2016: ADMINISTERED A TRANSVAGINAL ULTRASOUND WAS PERFORMED UTERUS- 9.83 X 5.60 X 4.61CM LEFT OVARY - 2.92 X 2.28 X 2.20CM RIGHT OVARY - 3.08 X 2.21 X 2.62CM ENDOMETRIUM - 9.8MM ANTEVERTED UTERUS NORMAL, ENDOMETRIUM APPEARS IRREGULAR, POSSIBLE CLOTS VISUALIZED. ESSURE COILS APPEAR SATISFACTORY, BILATERAL OVARIES APPEAR NORMAL, NO FF SEEN. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 13-SEP-2023: MR RECEIVED: EVENT "MEDICAL DEVICE REMOVAL UPDATED TO IUD EMBEDDED" LOT NUMBER ADDED. REPORTERS INFORMATION, MEDICAL HISTORY AND SURGICAL PATHOLOGICAL REPORTS WERE ADDED. INSERTION AD REMOVAL DATE UPDATED RCC UPDATED. 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 ("ESSURE+REMOVAL / SHINY SILVER MEDICAL DEVICE EMBEDDED ABOUT THE PROXIMAL TO MID LUMEN.") IN A 25 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. D06941) FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF SCOLIOSIS, PNEUMONIA, ABRUPTIO PLACENTAE, GASTROESOPHAGEAL REFLUX DISEASE, ECZEMA, CHICKENPOX, CHRONIC CERVICITIS, ENDOMETRIOSIS, MIGRAINE, BIPOLAR DISORDER, ANXIETY DISORDER, MULTIPLE CAESAREAN SECTIONS, PARITY 4, MULTI GRAVIDA, PERINEAL PAIN, DYSMENORRHEA, ABDOMINAL PAIN, MENORRHAGIA, MENSTRUATION ABNORMAL, PSYCHIATRIC DISORDER NOS, DEPRESSION, PERITONEAL ADHESIONS, ADENOMYOSIS AND PELVIC PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: DICLEGIS, TYLENOL, INDOMETHACIN [INDOMETACIN] AND ALPRAZOLAM. THE PATIENT HAD A FAMILY HISTORY OF OVARIAN CANCER. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 143 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED EMBEDDED DEVICE (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 EMBEDDED DEVICE TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: DISCREPANCY NOTED : INSERTION DATE AS PER ARGUS (B)(6) 2015. AS PER MR (B)(6) 2015. DISCREPANCY NOTED : REMOVAL DATE AS PER ARGUS (B)(6) 2015 AS PER MR (B)(6) 2016. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [PATHOLOGY TEST] ON (B)(6) 2016: SPECIMEN RECEIVED: CERVIX, UTERUS, BILATERAL TUBES. CLINICAL HISTORY: ENDOMETRIOSIS, ADENOMYOSIS, PELVIC PAIN, STERILIZATION FINAL DIAGNOSIS: CERVIX, UTERUS, BILATERAL TUBES : SEROSA: FIBROUS ADHESIONS. CERVIX: MILD CHRONIC ENDOCERVICITIS, DEFINITIVE ECTOCERVICAL MUCOSA IS NOT IDENTIFIED. ENDOMETRIUM: DISORDERED PROLIFERATIVE TYPE. MYOMETRIUM: UNREMARKABLE. RIGHT FALLOPIAN TUBE: STATUS POST COIL PLACEMENT. LEFT FALLOPIAN TUBE: STATUS POST COIL PLACEMENT. [PREGNANCY TEST] ON 22-DEC-2015: NEGATIVE [ULTRASOUND SCAN VAGINA] ON (B)(6) 2016: ADMINISTERED A TRANSVAGINAL ULTRASOUND WAS PERFORMED. UTERUS- 9.83 X 5.60 X 4.61CM. LEFT OVARY - 2.92 X 2.28 X 2.20CM. RIGHT OVARY - 3.08 X 2.21 X 2.62CM. ENDOMETRIUM - 9.8MM. ANTEVERTED UTERUS NORMAL, ENDOMETRIUM APPEARS IRREGULAR, POSSIBLE CLOTS VISUALIZED. ESSURE COILS APPEAR SATISFACTORY, BILATERAL OVARIES APPEAR NORMAL, NO FF SEEN. LOT NUMBER: D06941 MANUFACTURE DATE: 2014-09 EXPIRATION DATE: 2017-09. 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 ("ESSURE+REMOVAL") IN A 25 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, 60 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 AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("ESSURE+REMOVAL") IN A 25 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, 60 DAYS AFTER ESSURE INSERTION, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED) BY 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 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 |
|---|---|---|---|---|---|---|---|
| 257807 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | D06941 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Female | Required Intervention |