ESSURE
Report
- Report Number
- 2951250-2021-01064
- Event Type
- Injury
- Date Received
- March 31, 2021
- Report Date
- April 7, 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
- US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('RECEIVED IN FORMALIN ARE THREE PIECES OF SILVER METAL COIL DEVICES CONSISTENT WITH ESSURE COILS'), PELVIC PAIN ('SEVERE PAIN/ CHRONIC PELVIC PAIN') AND GENITAL HAEMORRHAGE ('EXCESSIVE BLEEDING') IN A 36-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802745) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: DEPO PROVERA FROM (B)(6) 2010 TO (B)(6) 2012. CONCURRENT CONDITIONS INCLUDED PELVIC ADHESIONS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA ("HEAVY MENSTRUAL BLEEDING"), PELVIC DISCOMFORT ("DISCOMFORT"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), BACK PAIN ("CHRONIC BACK PAIN"), HEADACHE ("FREQUENT HEADACHES"), MIGRAINE ("MIGRAINES"), ABNORMAL WEIGHT GAIN ("EXCESSIVE WEIGHT GAIN"), FATIGUE ("CHRONIC FATIGUE"), URINARY TRACT INFECTION ("FREQUENT URINARY TRACT INFECTIONS") AND TOOTH DISORDER ("EXCESSIVE DENTAL PROBLEMS"). THE PATIENT WAS TREATED WITH SURGERY (DIAGNOSTIC LAPAROSCOPY, BILATERAL SALPINGECTOMY, REMOVAL OF ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, GENITAL HAEMORRHAGE AND ABDOMINAL PAIN LOWER OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, MENORRHAGIA, PELVIC DISCOMFORT, ABDOMINAL PAIN, DYSPAREUNIA, BACK PAIN, HEADACHE, MIGRAINE, ABNORMAL WEIGHT GAIN, FATIGUE, URINARY TRACT INFECTION AND TOOTH DISORDER HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABNORMAL WEIGHT GAIN, BACK PAIN, DEVICE BREAKAGE, DYSPAREUNIA, FATIGUE, GENITAL HAEMORRHAGE, HEADACHE, MENORRHAGIA, MIGRAINE, PELVIC DISCOMFORT, PELVIC PAIN, TOOTH DISORDER AND URINARY TRACT INFECTION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. LAPAROSCOPY - ON (B)(6) 2020: PREOPERATIVE DIAGNOSIS: CHRONIC PELVIC PAIN, DYSPAREUNIA, DESIRES REMOVAL OF FOREIGN BODY WITH ESSURE COILS. POSTOPERATIVE DIAGNOSIS: CHRONIC PELVIC PAIN, DYSPAREUNIA, DESIRES REMOVAL OF FOREIGN BODY WITH ESSURE COILS, WITH THE ADDITION OF PELVIC ADHESIVE DISEASE. PROCEDURE: DIAGNOSTIC LAPAROSCOPY, BILATERAL SALPINGECTOMY, REMOVAL OF ESSURE COILS, LYSIS OF ADHESIONS. FINDINGS: THE PATIENT HAD PELVIC ADHESIVE DISEASE WITH AN OMENTAL ADHESION FROM THE UMBILICUS ALL THE WAY TO THE PELVIS, MORE SO ON THE PATIENT'S LEFT-HAND SIDE. THE PATIENT HAD A NORMAL-APPEARING UTERUS, TUBES, AND OVARIES, NORMAL-APPEARING OVARY, NORMAL APPEARING UPPER ABDOMINAL CONTENTS. PROCEDURE: THE CORNU, WE ISOLATED THE PATIENT'S ESSURE COILS. THEY WERE GRASPED AND PULLED OUT OF THE UTERUS AND DELIVERED THROUGH THE PORT. PATHOLOGY TEST - ON (B)(6) 2020: SURGICAL PATHOLOGY REPORT FINAL DIAGNOSIS: BILATERAL FALLOPIAN TUBES, ESSURE COILS: TWO SEGMENTS OF COMPLETELY TRANSECTED FALLOPIAN TUBES. SEE ALSO GROSS DESCRIPTION. PRE-OPERATIVE AND POST-OPERATIVE DIAGNOSIS: FOREIGN BODY IN UTERUS, DYSPAREUNIA. CLINICAL NOTES: NONE GIVEN. TISSUE: B FALLOPIAN TUBES, ESSURE COILS. GROSS DESCRIPTION: THE SPECIMEN IS IDENTIFIED ON THE REQUISITION AS B FALLOPIAN TUBES, ESSURE COILS AND ON THE CONTAINER AS BILATERAL FALLOPIAN TUBES. RECEIVED IN FORMALIN ARE THREE PIECES OF SILVER METAL COIL DEVICES CONSISTENT WITH ESSURE COILS. ALSO IN THE SPECIMEN CONTAINER ARE TWO CYLINDRICAL SEGMENTS OF PINK-PURPLE FALLOPIAN TUBE WITH ATTACHED FIMBRIATED END, 4.0 X 1.0 X 0.2 CM. NOTED ON THE FALLOPIAN TUBE ARE NUMEROUS SMALL CLEAR FLUID FILLED CYSTS, UP TO 0.1 CM IN DIAMETER. THE SECOND SEGMENT OF FALLOPIAN TUBE HAS AN ATTACHED FIMBRIATED END AND IS PINK-PURPLE, 4.5 X 0.5 X 0.3 CM. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENT¿S MEDICAL RECORDS: PELVIC PAIN, DYSPAREUNIA, DEVICE EXPULSION, DEVICE BREAKAGE LOT NUMBER: 802745 MANUFACTURING DATE: 2010/11 EXPIRATION DATE: 2013/11. 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 6-APR-2021: QUALITY SAFETY EVALUATION OF PTC. EVENT FOREIGN BODY IN UTERUS DELETED (ENTERED AS SURGERY DESCRIPTION IN LAB DATA). LAB DATA 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 BREAKAGE ('RECEIVED IN FORMALIN ARE THREE PIECES OF SILVER METAL COIL DEVICES CONSISTENT WITH ESSURE COILS'), PELVIC PAIN ('SEVERE PAIN/ CHRONIC PELVIC PAIN') AND GENITAL HAEMORRHAGE ('EXCESSIVE BLEEDING') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 802745) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: DEPO PROVERA FROM (B)(6) 2010 TO (B)(6) 2012. CONCURRENT CONDITIONS INCLUDED PELVIC ADHESIONS. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC DISCOMFORT ("DISCOMFORT"), MENORRHAGIA ("HEAVY MENSTRUAL BLEEDING"), ABNORMAL WEIGHT GAIN ("EXCESSIVE WEIGHT GAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("CHRONIC BACK PAIN"), FATIGUE ("CHRONIC FATIGUE"), MIGRAINE ("MIGRAINES") WITH HEADACHE, URINARY TRACT INFECTION ("FREQUENT URINARY TRACT INFECTIONS"), TOOTH DISORDER ("EXCESSIVE DENTAL PROBLEMS"), DYSPAREUNIA ("PAIN DURING INTERCOURSE"), ABDOMINAL PAIN LOWER ("LOWER ABDOMINAL PAIN") AND FOREIGN BODY IN REPRODUCTIVE TRACT ("FOREIGN BODY IN UTERUS"). THE PATIENT WAS TREATED WITH SURGERY (DIAGNOSTIC LAPAROSCOPY, BILATERAL SALPINGECTOMY, REMOVAL OF ESSURE COILS). ESSURE WAS REMOVED ON (B)(6) 2020. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, GENITAL HAEMORRHAGE, ABDOMINAL PAIN LOWER AND FOREIGN BODY IN REPRODUCTIVE TRACT OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, PELVIC DISCOMFORT, MENORRHAGIA, ABNORMAL WEIGHT GAIN, ABDOMINAL PAIN, BACK PAIN, FATIGUE, MIGRAINE, URINARY TRACT INFECTION, TOOTH DISORDER AND DYSPAREUNIA HAD NOT RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ABNORMAL WEIGHT GAIN, BACK PAIN, DEVICE BREAKAGE, DYSPAREUNIA, FATIGUE, FOREIGN BODY IN REPRODUCTIVE TRACT, GENITAL HAEMORRHAGE, MENORRHAGIA, MIGRAINE, PELVIC DISCOMFORT, PELVIC PAIN, TOOTH DISORDER AND URINARY TRACT INFECTION TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: RESULTS: TOTAL BILATERAL OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE CONFIRMED IN PATIENTS MEDICAL RECORDS: PELVIC PAIN, DYSPAREUNIA, DEVICE EXPULSION, DEVICE BREAKAGE QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-MAR-2021: THIS CASE BECOME SERIOUS INCIDENT. MR RECEIVED. REPORTER INFORMATION, PATIENT'S MEDICAL HISTORY, DATE EXPLANTED, EVENT : RECEIVED IN FORMALIN ARE THREE PIECES OF SILVER METAL COIL DEVICES CONSISTENT WITH ESSURE COILS, AND FOREIGN BODY IN REPRODUCTIVE TRACT ADDED.AUTO NARRATIVE SUPPLEMENT WERE 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 494031 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 802745 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other| R |