ESSURE
Report
- Report Number
- 2951250-2019-02676
- Event Type
- Injury
- Date Received
- June 10, 2019
- Report Date
- June 17, 2019
- 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
- FL, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERINE CAVITY/EXPULSION OF ESSURE DEVICE') AND DEVICE BREAKAGE ('DEVICE BREAKAGE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 904750) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERLIPIDEMIA, MULTIGRAVIDA, PARITY 3, D & C AND ADENOMYOSIS. SERUM PREGNANCY TEST: NEGATIVE. CONCURRENT CONDITIONS INCLUDED OBESITY, UTERINE FIBROIDS, POLYCYSTIC OVARIES, DIABETES AND HYPERTENSION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY TRACT DISORDER"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), MENOMETRORRHAGIA ("MENOMETRORRHAGIA") AND ENDOMETRIOSIS ("LASER VAPORIZATION OF ENDOMETRIOSIS"), WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND UNDERWENT OVARIAN DRILLING ("OVARIAN SUSPENSION, AND OVARIAN DRILLING"). THE PATIENT WAS TREATED WITH SURGERY (UNILATERAL SALPINGECTOMY/TOTAL HYSTERECTOMY/BILATERAL SALPINGECTOMY/OPERATIVE HYSTEROSCOPY/). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, DEVICE BREAKAGE, PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, NAUSEA, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, ALOPECIA, MENOMETRORRHAGIA, ENDOMETRIOSIS AND OVARIAN DRILLING OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, BLADDER DISORDER, DEVICE BREAKAGE, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FATIGUE, HEADACHE, MENOMETRORRHAGIA, MENORRHAGIA, MIGRAINE, NAUSEA, OVARIAN DRILLING, PELVIC PAIN, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF REMOVAL: (B)(6) 2013, (B)(6) 2017. THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY FROM THE RIGHT FALLOPIAN TUBE WERE 3. THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY FROM LEFT WAS 8. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 37.8 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULT: BILATERAL TUBAL OCCLUSION.. PATHOLOGY TEST - ON AN UNKNOWN DATE: RESULT: GROSS DESCRIPTION: THE SPECIMEN IS LABELED WITH THE PATIENT'S NAME, MEDICAL RECORD NUMBER, AND CLINICALLY IDENTIFIED AS ¿EXTENDED ESSURE ". IT¿S RECEIVED WITHOUT FORMALIN FOR GROSS EXAMINATION. IT CONSISTS OF A THREADLIKE, GRAY METALLIC DEVICE MEASURING 2 CM IN LENGTH AND LESS THAN 0.1 CM IN DIAMETER. DIAGNOSIS: ESSURE HARDWARE.. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JUN-2019: QUALITY SAFETY EVALUATION OF PTC. INCIDENT: 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERINE CAVITY/EXPULSION OF ESSURE DEVICE') AND DEVICE BREAKAGE ('DEVICE BREAKAGE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 904750) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERLIPIDEMIA, MULTIGRAVIDA, PARITY 3, D & C AND ADENOMYOSIS. SERUM PREGNANCY TEST: NEGATIVE. CONCURRENT CONDITIONS INCLUDED OBESITY, UTERINE FIBROIDS, POLYCYSTIC OVARIES, DIABETES AND HYPERTENSION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("MENORRHAGIA"), BLADDER DISORDER ("BLADDER OR URINARY PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY TRACT DISORDER"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), NAUSEA ("NAUSEA"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE "), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), MENOMETRORRHAGIA ("MENOMETRORRHAGIA") AND ENDOMETRIOSIS ("LASER VAPORIZATION OF ENDOMETRIOSIS"), WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN") AND UNDERWENT OVARIAN DRILLING ("OVARIAN SUSPENSION, AND OVARIAN DRILLING"). THE PATIENT WAS TREATED WITH SURGERY (UNILATERAL SALPINGECTOMY/TOTAL HYSTERECTOMY/BILATERAL SALPINGECTOMY/OPERATIVE HYSTEROSCOPY/). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE EXPULSION, DEVICE BREAKAGE, PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, BLADDER DISORDER, URINARY TRACT DISORDER, MIGRAINE, HEADACHE, NAUSEA, DYSMENORRHOEA, DYSPAREUNIA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED, ALOPECIA, MENOMETRORRHAGIA, ENDOMETRIOSIS AND OVARIAN DRILLING OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ALOPECIA, BLADDER DISORDER, DEVICE BREAKAGE, DEVICE EXPULSION, DYSMENORRHOEA, DYSPAREUNIA, ENDOMETRIOSIS, FATIGUE, HEADACHE, MENOMETRORRHAGIA, MENORRHAGIA, MIGRAINE, NAUSEA, OVARIAN DRILLING, PELVIC PAIN, URINARY TRACT DISORDER, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DATE(S) OF REMOVAL: (B)(6) 2013, (B)(6) 2017. THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY FROM THE RIGHT FALLOPIAN TUBE WERE 3. THE NUMBER OF EXPANDED COILS THAT APPEARED TRAILING INTO THE UTERINE CAVITY FROM LEFT WAS 8. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 37.8 KG/SQM. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULT: BILATERAL TUBAL OCCLUSION.. PATHOLOGY TEST - ON AN UNKNOWN DATE: RESULT: GROSS DESCRIPTION: THE SPECIMEN IS LABELED WITH THE PATIENT'S NAME, MEDICAL RECORD NUMBER, AND CLINICALLY IDENTIFIED AS ¿EXTENDED ESSURE ". IT¿S RECEIVED WITHOUT FORMALIN FOR GROSS EXAMINATION. IT CONSISTS OF A THREADLIKE, GRAY METALLIC DEVICE MEASURING 2 CM IN LENGTH AND LESS THAN 0.1 CM IN DIAMETER. DIAGNOSIS: ESSURE HARDWARE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-JUN-2019: PFS RECEIVED. ESSURE LOT NUMBER ADDED. PRODUCT INDICATION AND ESSURE IMPLANT DATE UPDATED. RACE INFORMATION AND ESSURE EXPLANT DATE ADDED. FOLLOWING EVENTS WERE ADDED: MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UTERINE CAVITY/EXPULSION OF ESSURE DEVICE, DEVICE BREAKAGE, ABNORMAL BLEEDING (VAGINAL), MENORRHAGIA, MENOMETRORRHAGIA,BLADDER OR URINARY PROBLEMS OR CHANGES, URINARY TRACT DISORDER, MIGRAINES, HEADACHES, NAUSEA, DYSMENORRHEA (CRAMPING), OVARIAN SUSPENSION, OVARIAN DRILLING, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), VAGINAL DISCHARGE, FATIGUE, WEIGHT GAIN, HAIR LOSS, LASER VAPORIZATION OF ENDOMETRIOSIS AND OVARIAN SUSPENSION, AND OVARIAN DRILLING. PREVIOUSLY REPORTED EVENT INJURY WAS UPDATED TO PELVIC PAIN. MEDICAL HISTORY AND LAB DATA WERE ADDED. REPORTERS ADDED. INCIDENT: 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 NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 477995 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 904750 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |