ESSURE
Report
- Report Number
- 2951250-2021-01021
- Event Type
- Malfunction
- Date Received
- March 26, 2021
- Date of Event
- January 1, 2017
- Report Date
- March 30, 2021
- 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
- BR
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('DEVICE FRAGMENTED') AND DEVICE DISLOCATION ('LINEAR METALLIC MATERIAL IN THE PELVIS ON THE LEFT') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880437) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIGRAVIDA, MULTIGRAVIDA AND ABORTION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPOPROVERA. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. IN 2015, THE PATIENT EXPERIENCED UTERINE INFLAMMATION ("UTERINE INFLAMMATION (LACTOBACILLUS SP)"). IN 2017, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("STRONG AND SHARP PELVIC PAIN"), BREAST PAIN ("MASTALGIA"), ABDOMINAL DISTENSION ("DISTENSION"), OEDEMA ("EDEMA"), MENORRHAGIA ("HEAVY AND PRONLONGED MENSTRUATION WITH CLOTS"), HEADACHE ("INTENSE HEADACHES"), PAIN IN EXTREMITY ("LEG PAIN"), PERIPHERAL SWELLING ("LEG SWELLING"), HYPOAESTHESIA ("NUMBNESS"), TREMOR ("TREMOR"), BACK PAIN ("LUMBAR PAIN"), UTERINE PAIN ("UTERINE PERFORATION SENSATION/ SHARP PAIN"), FATIGUE ("FATIGUE"), LOSS OF LIBIDO ("LOSS OF LIBIDO"), DYSPAREUNIA ("PAIN DURING SEXUAL INTERCOURSE"), COITAL BLEEDING ("BLEEDING DURING SEXUAL INTERCOURSE"), ARTHRALGIA ("JOINT PAIN"), MOOD ALTERED ("MOOD CHANGES"), ALOPECIA ("HAIR LOSS"), ADENOMYOSIS ("SUSPICION OF ADENOMYOSIS"), INTRA-ABDOMINAL FLUID COLLECTION ("ABDOMINAL FLUID"), PAIN ("PAIN GENERALIZED"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE WITH ODOR"), ANXIETY ("ANXIETY"), NERVOUSNESS ("NERVOUSNESS"), STRESS ("STRESS"), DIZZINESS ("DIZZINESS"), DIARRHOEA ("DIARRHEA") AND DEPRESSION ("DEPRESSION"). THE PATIENT WAS TREATED WITH ANALGESICS AND ANTIINFLAMMATORY AGENTS. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE AND DEVICE DISLOCATION OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, BREAST PAIN, ABDOMINAL DISTENSION, OEDEMA, MENORRHAGIA, HEADACHE, PAIN IN EXTREMITY, PERIPHERAL SWELLING, HYPOAESTHESIA, TREMOR, BACK PAIN, UTERINE PAIN, FATIGUE, LOSS OF LIBIDO, DYSPAREUNIA, COITAL BLEEDING, UTERINE INFLAMMATION, ARTHRALGIA, MOOD ALTERED, ALOPECIA, ADENOMYOSIS, INTRA-ABDOMINAL FLUID COLLECTION, PAIN, VAGINAL DISCHARGE, ANXIETY, NERVOUSNESS, STRESS, DIZZINESS, DIARRHOEA AND DEPRESSION HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ADENOMYOSIS, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, BREAST PAIN, COITAL BLEEDING, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DIARRHOEA, DIZZINESS, DYSPAREUNIA, FATIGUE, HEADACHE, HYPOAESTHESIA, INTRA-ABDOMINAL FLUID COLLECTION, LOSS OF LIBIDO, MENORRHAGIA, MOOD ALTERED, NERVOUSNESS, OEDEMA, PAIN, PAIN IN EXTREMITY, PELVIC PAIN, PERIPHERAL SWELLING, STRESS, TREMOR, UTERINE INFLAMMATION, UTERINE PAIN AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HUMAN CHORIONIC GONADOTROPIN - ON (B)(6) 2014: PREGNANCY NEGATIVE. X-RAY - ON AN UNKNOWN DATE: LINEAR METALLIC MATERIAL IN THE PELVIS ON THE LEFT; ONE LEFT. PCTE REPORTS THAT THE RIGHT HORN HOLE WOULD NOT HAVE BEEN FOUND. 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 29-MAR-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 BREAKAGE ('DEVICE FRAGMENTED') AND DEVICE DISLOCATION ('LINEAR METALLIC MATERIAL IN THE PELVIS ON THE LEFT') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880437) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED PREGNANCY, VAGINAL DELIVERY AND ABORTION. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DEPOPROVERA. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. IN 2015, THE PATIENT EXPERIENCED UTERINE INFLAMMATION ("UTERINE INFLAMMATION (LACTOBACILLUS SP)"). IN 2017, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), PELVIC PAIN ("STRONG AND SHARP PELVIC PAIN"), BREAST PAIN ("MASTALGIA"), ABDOMINAL DISTENSION ("DISTENSION"), OEDEMA ("EDEMA"), MENORRHAGIA ("HEAVY AND PRONLONGED MENSTRUATION WITH CLOTS"), HEADACHE ("INTENSE HEADACHES"), PAIN IN EXTREMITY ("LEG PAIN"), PERIPHERAL SWELLING ("LEG SWELLING"), HYPOAESTHESIA ("NUMBNESS"), TREMOR ("TREMOR"), BACK PAIN ("LUMBAR PAIN"), UTERINE PAIN ("UTERINE PERFORATION SENSATION/ SHARP PAIN"), FATIGUE ("FATIGUE"), LOSS OF LIBIDO ("LOSS OF LIBIDO"), DYSPAREUNIA ("PAIN DURING SEXUAL INTERCOURSE"), COITAL BLEEDING ("BLEEDING DURING SEXUAL INTERCOURSE"), ARTHRALGIA ("JOINT PAIN"), MOOD ALTERED ("MOOD CHANGES"), ALOPECIA ("HAIR LOSS"), ADENOMYOSIS ("SUSPICION OF ADENOMYOSIS"), INTRA-ABDOMINAL FLUID COLLECTION ("ABDOMINAL FLUID"), PAIN ("PAIN GENERALIZED"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE WITH ODOR"), ANXIETY ("ANXIETY"), NERVOUSNESS ("NERVOUSNESS"), STRESS ("STRESS"), DIZZINESS ("DIZZINESS"), DIARRHOEA ("DIARRHEA") AND DEPRESSION ("DEPRESSION"). THE PATIENT WAS TREATED WITH ANALGESICS AND ANTIINFLAMMATORY AGENTS. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE AND DEVICE DISLOCATION OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, BREAST PAIN, ABDOMINAL DISTENSION, OEDEMA, MENORRHAGIA, HEADACHE, PAIN IN EXTREMITY, PERIPHERAL SWELLING, HYPOAESTHESIA, TREMOR, BACK PAIN, UTERINE PAIN, FATIGUE, LOSS OF LIBIDO, DYSPAREUNIA, COITAL BLEEDING, UTERINE INFLAMMATION, ARTHRALGIA, MOOD ALTERED, ALOPECIA, ADENOMYOSIS, INTRA-ABDOMINAL FLUID COLLECTION, PAIN, VAGINAL DISCHARGE, ANXIETY, NERVOUSNESS, STRESS, DIZZINESS, DIARRHOEA AND DEPRESSION HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ADENOMYOSIS, ALOPECIA, ANXIETY, ARTHRALGIA, BACK PAIN, BREAST PAIN, COITAL BLEEDING, DEPRESSION, DEVICE BREAKAGE, DEVICE DISLOCATION, DIARRHOEA, DIZZINESS, DYSPAREUNIA, FATIGUE, HEADACHE, HYPOAESTHESIA, INTRA-ABDOMINAL FLUID COLLECTION, LOSS OF LIBIDO, MENORRHAGIA, MOOD ALTERED, NERVOUSNESS, OEDEMA, PAIN, PAIN IN EXTREMITY, PELVIC PAIN, PERIPHERAL SWELLING, STRESS, TREMOR, UTERINE INFLAMMATION, UTERINE PAIN AND VAGINAL DISCHARGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HUMAN CHORIONIC GONADOTROPIN ON (B)(6) 2014: PREGNANCY NEGATIVE. X-RAY ON AN UNKNOWN DATE: LINEAR METALLIC MATERIAL IN THE PELVIS ON THE LEFT; ONE LEFT. PCTE REPORTS THAT THE RIGHT HORN HOLE WOULD NOT HAVE BEEN FOUND. 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 |
|---|---|---|---|---|---|---|---|
| 472037 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 880437 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Other |