ESSURE
Report
- Report Number
- 2951250-2020-15751
- Event Type
- Injury
- Date Received
- December 2, 2020
- Report Date
- February 10, 2021
- 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
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('REMOVAL') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-DEC-2020: 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 REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ('THREE ESSURE COILS DOWN IN THE SPECIMEN., 2 COILS ON ONE SIDE OF THE UTERUS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 508835, 822308) INSERTED FOR FEMALE STERILISATION. THE PATIENT'S MEDICAL HISTORY INCLUDED CERVICITIS, NABOTHIAN CYST, MENOMETRORRHAGIA AND PELVIC PAIN. ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY.). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE EXPULSION TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: ON THE LEFT TUBAL OSTIA, THERE WAS NOTED TO HAVE FOUR COILS PRESENT IN THE UTERINE SIDE OF THE TUBAL OSTIA AND ON THE RIGHT SIDE, SHE HAS FIVE COILS PRESENT AT THE OPENING OF THE TUBAL OSTIA. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021: FU 2 &3 PROCESS TOGETHER. MEDICAL RECORD RECEIVED EVENT " THREE ESSURE COILS DOWN IN THE SPECIMEN. 2 COILS ON ONE SIDE OF THE UTERUS" WAS ADDED. REPORTER INFORMATION AND MEDICAL HISTORY WERE ADDED ON (B)(6) 2021: FU 2 &3 PROCESS TOGETHER. MEDICAL RECORD RECEIVED LOT NUMBER WAS ADDED. REPORTER INFORMATION WAS 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 REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 822308-NOT VALID,508835) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED CERVICITIS, NABOTHIAN CYST, MENOMETRORRHAGIA AND PELVIC PAIN. ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENOMETRORRHAGIA ("MENOMETRORRHAGIA"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY.). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND MENOMETRORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MENOMETRORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: ON THE LEFT TUBAL OSTIA, THERE WAS NOTED TO HAVE FOUR COILS PRESENT IN THE UTERINE SIDE OF THE TUBAL OSTIA AND ON THE RIGHT SIDE, SHE HAS FIVE COILS PRESENT AT THE OPENING OF THE TUBAL OSTIA. THE PATIENT HAD AN ARCUATE UTERUS MARCH 8TH. SHE HAD 2 COILS ON ONE SIDE OF THE UTERUS AND ONE ON THE OTHER THAT WAS DETERMINED PRIOR TO THE SURGERY AS WELL AS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PATHOLOGY TEST - ON (B)(6) 2020: FINAL DIAGNOSIS UTERUS CERVIX, UTERUS, BILATERAL FALLOPIAN TUBES UTERUS AND BILATERAL FALLOPIAN TUBES, DA VINCI TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY: CERVIX: FOCAL EROSION, CHRONIC CERVICITIS AND NABOTHIAN CYSTS. ENDOMETRIUM: BENIGN, EARLY SECRETORY PHASE ENDOMETRIUM. MYOMETRIUM: UNREMARKABLE. SEROSA: ENDOMETRIOSIS, SMALL SUBSEROSAL LEIOMYOMA, AND ADHESIONS. FALLOPIAN TUBE #1: SMALL, BENIGN HYDATID CYST OF MORGAGNI; ESSURE COIL. FALLOPIAN TUBE #2: CYSTIC WALTHARD REST; ESSURE COIL.. LOT NUMBER REPORTED (822308) IS INV. LOT NUMBER: 508835, MANUFACTURING DATE: 2005/08, EXPIRATION DATE: 2007/07 . QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-FEB-2021: 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 REPORTED BY A LAWYER, AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN'). IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 822308-NOT VALID,508835), INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED: CERVICITIS, NABOTHIAN CYST, MENOMETRORRHAGIA AND PELVIC PAIN. ON (B)(6) 2007, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND MENOMETRORRHAGIA ("MENOMETRORRHAGIA"). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY). ESSURE (ESS205) WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND MENOMETRORRHAGIA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MENOMETRORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: ON THE LEFT TUBAL OSTIA, THERE WAS NOTED, TO HAVE FOUR COILS PRESENT IN THE UTERINE SIDE OF THE TUBAL OSTIA. AND ON THE RIGHT SIDE, SHE HAS FIVE COILS PRESENT AT THE OPENING OF THE TUBAL OSTIA. THE PATIENT HAD AN ARCUATE UTERUS (B)(6). SHE HAD 2 COILS ON ONE SIDE OF THE UTERUS. AND ONE ON THE OTHER THAT WAS DETERMINED, PRIOR TO THE SURGERY AS WELL AS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PATHOLOGY TEST: ON (B)(6) 2020, FINAL DIAGNOSIS: UTERUS CERVIX, UTERUS, BILATERAL FALLOPIAN TUBES UTERUS AND BILATERAL FALLOPIAN TUBES, DA VINCI TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY; CERVIX: FOCAL EROSION, CHRONIC CERVICITIS AND NABOTHIAN CYSTS; ENDOMETRIUM: BENIGN, EARLY SECRETORY PHASE ENDOMETRIUM; MYOMETRIUM: UNREMARKABLE; SEROSA: ENDOMETRIOSIS, SMALL SUBSEROSAL LEIOMYOMA, AND ADHESIONS; FALLOPIAN TUBE #1: SMALL, BENIGN HYDATID CYST OF MORGAGNI, ESSURE COIL. FALLOPIAN TUBE #2: CYSTIC WALTHARD REST, ESSURE COIL. LOT NUMBER REPORTED (822308) IS NOT VALID. QUALITY SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021, UPDATE OF INFORMATION (BATCH IS NOT VALID). EVENT DEVICE EXPULSION DELETED. AS PER SOURCE DOCUMENT DATED. ON (B)(6) 2021, DEVICE EXPULSION IS NOT REPORTED. NEW EVENTS: CHRONIC PELVIC PAIN, MENOMETRORRHAGIA AND LAB DATA ADDED. FROM SD DATED: (B)(6) 2021. 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 REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('REMOVAL') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. 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 |
|---|---|---|---|---|---|---|---|
| 1398364 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS205 | 822308-NOT VALID,508835 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |