ESSURE
Report
- Report Number
- 2951250-2019-08570
- Event Type
- Injury
- Date Received
- September 26, 2019
- Report Date
- August 25, 2021
- 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 ('MIGRATION') AND PREMATURE LABOUR ('PRETERM LABOR') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863570) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIPAROUS, ASTHMA, MIGRAINE HEADACHE, UTI, MULTIGRAVIDA, VAGINAL DELIVERY, HERNIA REPAIR, BLEEDING MENSTRUAL HEAVY, ANEMIA, ASTHMA, BACTERIAL VAGINOSIS, COUGH, GESTATIONAL DIABETES, FIBROIDS, FLU-LIKE SYMPTOMS, MENORRHAGIA, OBESITY, VAGINITIS, TRICHOMONIASIS, YEAST INFECTION, SEASONAL ALLERGY, DEPRESSIVE DISORDER, HERPES ZOSTER, TINEA CORPORIS, VAGINAL ABSCESS, UTERINE DILATION AND CURETTAGE, CONSTIPATION, SLEEP DISORDER, ANXIETY, DYSURIA, URINARY FREQUENCY, URINARY HESITANCY AND DYSMENORRHEA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO-PROVERA. 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), PREMATURE LABOUR (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN/ CHRONIC PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN/CHRONIC PAIN") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY WITH CONTRACEPTIVE DEVICE"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY ROBOTIC UMBILICAL HERNIORRHAPHY). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PREMATURE LABOUR, PELVIC PAIN, ABDOMINAL PAIN AND PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 11, PARA 10. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE VAGINAL DELIVERY OCCURRED ON (B)(6) 2020. 3174.5G WAS THE REPORTED BIRTH WEIGHT. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE DISLOCATION, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND PREMATURE LABOUR TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: FIVE COILS WERE OBSERVED OUTSIDE LEFT OSTIUM, FIVE COILS WERE ALSO SEEN IN RIGHT OSTIUM. LOT NUMBER: 863570, MANUFACTURING DATE: 2011/05, AND EXPIRATION DATE: 2014/05. QUALITY-SAFETY EVALUATION OF PTC: 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-AUG-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 DEVICE DISLOCATION ('MIGRATION') AND PREMATURE LABOUR ('PRETERM LABOR') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863570) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE "DEVICE INEFFECTIVE" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIPAROUS, ASTHMA, MIGRAINE HEADACHE, UTI, MULTIGRAVIDA, VAGINAL DELIVERY, HERNIA REPAIR, BLEEDING MENSTRUAL HEAVY, ANEMIA, ASTHMA, BACTERIAL VAGINOSIS, COUGH, GESTATIONAL DIABETES, FIBROIDS, FLU-LIKE SYMPTOMS, MENORRHAGIA, OBESITY, VAGINITIS, TRICHOMONIASIS, YEAST INFECTION, SEASONAL ALLERGY, DEPRESSIVE DISORDER, HERPES ZOSTER, TINEA CORPORIS, VAGINAL ABSCESS, UTERINE DILATION AND CURETTAGE, CONSTIPATION, SLEEP DISORDER, ANXIETY, DYSURIA, URINARY FREQUENCY, URINARY HESITANCY AND DYSMENORRHEA. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPO-PROVERA. 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), PREMATURE LABOUR (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN/ CHRONIC PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN/CHRONIC PAIN") AND WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY WITH CONTRACEPTIVE DEVICE"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY ROBOTIC UMBILICAL HERNIORRHAPHY). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PREMATURE LABOUR, PELVIC PAIN, ABDOMINAL PAIN AND PREGNANCY WITH CONTRACEPTIVE DEVICE OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. THE PATIENT'S OBSTETRIC STATUS WAS GRAVIDA 11, PARA 10. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST, SECOND AND THIRD TRIMESTERS. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH. IT WAS UNKNOWN WHETHER THE CHILD WAS HEALTHY. THE VAGINAL DELIVERY OCCURRED ON (B)(6) 2020. 3174.5G WAS THE REPORTED BIRTH WEIGHT. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE DISLOCATION, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND PREMATURE LABOUR TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: FIVE COILS WERE OBSERVED OUTSIDE LEFT OSTIUM, FIVE COILS WERE ALSO SEEN IN RIGHT OSTIUM. LOT NUMBER: 863570, MANUFACTURING DATE: 2011/05, AND EXPIRATION DATE: 2014/05. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 19-AUG-2021: MR RECEIVED: EVENT PRETERM LABOR ADDED AND MADE MEDIALLY SIGNIFICANT AND INTERVENTION REQUIRED DUE TO SURGERY. OTHER EVENT PREGNANCY WITH CONTRACEPTIVE DEVICE AND DEVICE INEFFECTIVE ADDED. REPORTER, MEDICAL HISTORY , HISTORICAL DRUG AND ESSURE REMOVAL DATE ADDED. 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 ('MIGRATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863570) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIPAROUS, ASTHMA AND MIGRAINE HEADACHE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN/ CHRONIC PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN/CHRONIC PAIN"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE DISLOCATION AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: FIVE COILS WERE OBSERVED OUTSIDE LEFT OSTIUM, FIVE COILS WERE ALSO SEEN IN RIGHT OSTIUM. LOT NUMBER:863570 MANUFACTURING DATE: 2011/05 EXPIRATION DATE: 2014/05. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-DEC-2020: 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 DEVICE DISLOCATION ('MIGRATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 863570) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO AN ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIPAROUS, ASTHMA AND MIGRAINE HEADACHE. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN/ CHRONIC PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN/CHRONIC PAIN"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE DISLOCATION AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: FIVE COILS WERE OBSERVED OUTSIDE LEFT OSTIUM, FIVE COILS WERE ALSO SEEN IN RIGHT OSTIUM. LOT NUMBER: 863570. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-DEC-2020: MEDICAL RECORDS RECEIVED. REPORTER INFORMATION, LOT NUMBER 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 DEVICE DISLOCATION ('MIGRATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERWENT FOR AN ESSURE CONFORMATION TEST". ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("PELVIC PAIN/ CHRONIC PAIN") AND ABDOMINAL PAIN ("ABDOMINAL PAIN/CHRONIC PAIN"). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN AND ABDOMINAL PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, DEVICE DISLOCATION AND PELVIC PAIN TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 11-SEP-2019: PFS RECEIVED- INJURY NOS WAS REPLACED WITH PELVIC PAIN, ABDOMINAL PAIN, MIGRATION WERE ADDED. LAWYER WAS ADDED. NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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 |
|---|---|---|---|---|---|---|---|
| 916468 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 863570 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |