ESSURE
Report
- Report Number
- 2951250-2020-15006
- Event Type
- Injury
- Date Received
- October 20, 2020
- Report Date
- October 27, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('PROBABLE MALPOSITIONING OF THE ESSURE DEVICE') AND ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ('ECTOPIC PREGNANCY') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841528, 653903) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED ABDOMINAL PAIN, VOMITING, HYPERTHYROIDISM, DYSMENORRHEA, MENORRHAGIA, CERVICITIS, THYROIDECTOMY AND RECURRENT ABORTION. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPS") AND MENOMETRORRHAGIA ("HEAVY IRREGULAR BLEEDING") AND WAS FOUND TO HAVE AN ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY, BILATERAL SALPINGECTOMY.). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, PELVIC PAIN, ABDOMINAL PAIN LOWER AND MENOMETRORRHAGIA OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DEVICE DISLOCATION, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, MENOMETRORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TRAILING COILS: LEFT 1 RIGHT 6 (LOT NUMBER: 841528 (LEFT), 653903 (RIGHT)). PATIENT EXPERIENCE ANOTHER THREE PREGNANCY ( MISCARRIAGE) EPISODE WHICH WAS CAPTURED UNDER CASE (B)(4). LOT NUMBER: 653903, MANUFACTURING DATE: 2009-06, EXPIRATION DATE: 2012-06. LOT NUMBER: 841528, MANUFACTURING DATE: 2011-03, EXPIRATION DATE: 2014-03. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINTS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-OCT-2020: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). 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 DEVICE DISLOCATION ('PROBABLE MALPOSITIONING OF THE ESSURE DEVICE') AND ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE ('ECTOPIC PREGNANCY') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841528, 653903) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED ABDOMINAL PAIN, VOMITING, HYPERTHYROIDISM, DYSMENORRHEA, MENORRHAGIA, CERVICITIS, THYROIDECTOMY AND RECURRENT ABORTION. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN"), ABDOMINAL PAIN LOWER ("SEVERE CRAMPS") AND MENOMETRORRHAGIA ("HEAVY IRREGULAR BLEEDING") AND WAS FOUND TO HAVE AN ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY, BILATERAL SALPINGECTOMY.). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, PELVIC PAIN, ABDOMINAL PAIN LOWER AND MENOMETRORRHAGIA OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DEVICE DISLOCATION, ECTOPIC PREGNANCY WITH CONTRACEPTIVE DEVICE, MENOMETRORRHAGIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TRAILING COILS: LEFT 1 RIGHT 6 (LOT NUMBER: 841528 (LEFT), 653903 (RIGHT)). PATIENT EXPERIENCE ANOTHER THREE PREGNANCY ( MISCARRIAGE) EPISODE WHICH WAS CAPTURED UNDER CASE (B)(4). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINTS. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-OCT-2020: PIF RECEIVED: THE EVENTS "PELVIC PAIN, SEVERE CRAMPS AND HEAVY IRREGULAR BLEEDING" WERE ADDED, AND PREGNANCY WAS UPDATED TO ECTOPIC PREGNANCY. THE EVENT MISSED ABORTION WAS DELETED. 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 DEVICE DISLOCATION ('PROBABLE MALPOSITIONING OF THE ESSURE DEVICE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (305) (BATCH NO. 841528, 653903) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE". THE PATIENT'S MEDICAL HISTORY INCLUDED ABDOMINAL PAIN, VOMITING, HYPERTHYROIDISM, DYSMENORRHEA, MENORRHAGIA, CERVICITIS, THYROIDECTOMY, ECTOPIC PREGNANCY AND RECURRENT ABORTION. ON (B)(6) 2011, THE PATIENT HAD ESSURE (305) INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND ABORTION MISSED ("MISSED ABORTION") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PATIENT HAS HAD AN ECTOPIC PREGNANCY AND AT LEAST 3 MISCARRIAGES"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY, BILATERAL SALPINGECTOMY.). ESSURE (305) WAS REMOVED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PREGNANCY WITH CONTRACEPTIVE DEVICE AND ABORTION MISSED OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: PROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED ABORTION MISSED, DEVICE DISLOCATION AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE (305). THE REPORTER COMMENTED: TRAILING COILS: LEFT 1 RIGHT 6. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINTS. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1167464 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841528, 653903 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |