ESSURE
Report
- Report Number
- 2951250-2019-03558
- Event Type
- Malfunction
- Date Received
- July 10, 2019
- Date of Event
- January 1, 2014
- Report Date
- July 15, 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
- US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ('MALPOSITION OF ESSURE DEVICE TYPE: LOCATION OF DEVICE: UNKNOWN/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT COILS MIGRATED OUT OF PLACE/ LEFT COILS MIGRATED INTO THE MYOMETRIUM/THE ESSURE MICROFILAMENT DEVICE WAS VISIBLE WITHIN THE MYOMETRIUM'), DEVICE BREAKAGE ('DEVICE BREAKAGE') AND PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY (WITH COMPLICATIONS)/ ), SHE BECAME PREGNANT WITH ESSURE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B82472-VALID,882472-NOT VALID) 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/FAILURE TO OCCLUDE FALLOPIAN TUBE" IN 2014. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERTENSION, CERVICAL DYSPLASIA, ARTHRITIS, PAIN, SEASONAL ALLERGY, FEVER, CHILLS, FATIGUE, SWELLING NOS, NIGHT SWEATS, SORE THROAT, COUGH, SHORTNESS OF BREATH, CHEST PAIN, DIARRHEA, CONSTIPATION, DIARRHEA, VOMITING, BLOOD IN STOOL, HEMATURIA AND JOINT STIFFNESS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVE NOS. CONCOMITANT PRODUCTS INCLUDED INTRAUTERINE CONTRACEPTIVE DEVICE (PARAGARD) SINCE (B)(6) 2018. IN 2014, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2017, THE PATIENT EXPERIENCED HYPERTENSION ("BLOOD OR HEART DISORDER/CONDITION TYPE: HIGH BLOOD PRESSURE"). IN (B)(6) 2018, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA)/ HEAVY IRREGULAR BLEEDING"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/ PAIN AFTER INTERCOURSE"), PELVIC PAIN ("PAIN") AND ABDOMINAL PAIN LOWER ("RIGHT AND LEFT LOWER QUADRANT PAIN") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES DESCRIBE: OUT OF WACK"). THE PATIENT WAS TREATED WITH SURGERY. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, DEVICE BREAKAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, HEADACHE, HYPERTENSION, DYSPAREUNIA, PELVIC PAIN, ABDOMINAL PAIN LOWER AND HORMONE LEVEL ABNORMAL OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: PROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DEVICE BREAKAGE, DYSPAREUNIA, EMBEDDED DEVICE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERTENSION, MENORRHAGIA, MIGRAINE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED). LOT NUMBERS REPORTED (B82472 IS VALID, 882472 IS INVALID). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-JUL-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 EMBEDDED DEVICE ('MALPOSITION OF ESSURE DEVICE TYPE: LOCATION OF DEVICE: UNKNOWN/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT COILS MIGRATED OUT OF PLACE/ LEFT COILS MIGRATED INTO THE MYOMETRIUM/THE ESSURE MICROFILAMENT DEVICE WAS VISIBLE WITHIN THE MYOMETRIUM'), DEVICE BREAKAGE ('DEVICE BREAKAGE') AND PREGNANCY WITH CONTRACEPTIVE DEVICE ('PREGNANCY (WITH COMPLICATIONS)/ ), SHE BECAME PREGNANT WITH ESSURE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B82472/ 882472) 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/FAILURE TO OCCLUDE FALLOPIAN TUBE" IN 2014. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERTENSION, CERVICAL DYSPLASIA, ARTHRITIS, PAIN, SEASONAL ALLERGY, FEVER, CHILLS, FATIGUE, SWELLING, NIGHT SWEATS, SORE THROAT, COUGH, SHORTNESS OF BREATH, CHEST PAIN, DIARRHEA, CONSTIPATION, DIARRHEA, VOMITING, BLOOD IN STOOL, HEMATURIA AND JOINT STIFFNESS. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVE NOS. CONCOMITANT PRODUCTS INCLUDED INTRAUTERINE CONTRACEPTIVE DEVICE (PARAGARD) SINCE (B)(6) 2018. IN 2014, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN 2017, THE PATIENT EXPERIENCED HYPERTENSION ("BLOOD OR HEART DISORDER/CONDITION TYPE: HIGH BLOOD PRESSURE"). IN (B)(6) 2018, THE PATIENT WAS FOUND TO HAVE A PREGNANCY WITH CONTRACEPTIVE DEVICE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), MENORRHAGIA ("ABNORMAL BLEEDING ( MENORRHAGIA)/ HEAVY IRREGULAR BLEEDING"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)/ PAIN AFTER INTERCOURSE"), PELVIC PAIN ("PAIN") AND ABDOMINAL PAIN LOWER ("RIGHT AND LEFT LOWER QUADRANT PAIN") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES DESCRIBE: OUT OF WACK"). THE PATIENT WAS TREATED WITH SURGERY. ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, DEVICE BREAKAGE, PREGNANCY WITH CONTRACEPTIVE DEVICE, VAGINAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, HEADACHE, HYPERTENSION, DYSPAREUNIA, PELVIC PAIN, ABDOMINAL PAIN LOWER AND HORMONE LEVEL ABNORMAL OUTCOME WAS UNKNOWN. PREGNANCY RELATED INFORMATION: PROSPECTIVE REPORT. LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. POTENTIAL FETAL EXPOSURE TO ESSURE OCCURRED DURING THE FIRST TRIMESTER. THE PREGNANCY OUTCOME WAS NOT REPORTED. THE REPORTER CONSIDERED ABDOMINAL PAIN LOWER, DEVICE BREAKAGE, DYSPAREUNIA, EMBEDDED DEVICE, HEADACHE, HORMONE LEVEL ABNORMAL, HYPERTENSION, MENORRHAGIA, MIGRAINE, PELVIC PAIN, PREGNANCY WITH CONTRACEPTIVE DEVICE AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2014: UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED). QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 1-JUL-2019: REPORTER AND PATIENT DEMOGRAPHICS, MEDICAL HISTORY AND HISTORICAL DRUG AND LABORATORY DATA WERE ADDED. SUSPECT DRUG INDICATION AND LOT NUMBER ADDED. ON (B)(6) 2014, SHE IMPLANTED ESSURE (PREVIOUSLY REPORTED AS 2014). ADDED EVENTS HORMONAL CHANGES DESCRIBE: OUT OF WACK, PREGNANCY (WITH COMPLICATIONS)/ SHE BECAME PREGNANT WITH ESSURE,ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA, MIGRAINES / HEADACHES, BLOOD OR HEART DISORDER/CONDITION TYPE: HIGH BLOOD PRESSURE, MALPOSITION OF ESSURE DEVICE TYPE: LOCATION OF DEVICE: UNKNOWN/ MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT COILS MIGRATED OUT OF PLACE/ LEFT COILS MIGRATED INTO THE MYOMETRIUM , DEVICE BREAKAGE, DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), PAIN, RIGHT AND LEFT LOWER QUADRANT PAIN. EVENT INJURY WAS DELETED. 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 |
|---|---|---|---|---|---|---|---|
| 568150 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | B82472-VALID,882472-NOT VALID | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Other | PARAGARD| PARAGARD |