ESSURE
Report
- Report Number
- 2951250-2018-03830
- Event Type
- Injury
- Date Received
- August 30, 2018
- Date of Event
- May 1, 2014
- Report Date
- March 20, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ("HEAVY MENSTRUAL BLEEDING/HEAVY BLEEDING") IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872572-INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ENDOMETRIAL ABLATION PERFORMED WITH ESSURE BILATERAL TUBAL STERILIZATIONS" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED TACHYCARDIA, PELVIC PAIN FEMALE, DYSFUNCTIONAL UTERINE BLEEDING, UTERINE BLEEDING, PNEUMONIA AND KIDNEY INFECTION. CONCURRENT CONDITIONS INCLUDED BACK PAIN, LEG PAIN, PELVIC PERITONEAL ADHESIONS, FLANK PAIN, DYSURIA, VOMITING, CHILLS, FEVER, PYELONEPHRITIS AND UTI. CONCOMITANT PRODUCTS INCLUDED OXYCOCET (PERCOCET). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER ("CRAMPING/LOWER ABDOMEN PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN/PAIN"), BACK PAIN ("BACK PAIN") AND DYSPAREUNIA ("PAIN DURING INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION DONE ON (B)(6) 2015). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN, BACK PAIN AND DYSPAREUNIA HAD NOT RESOLVED AND THE MIGRAINE, HEADACHE AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, MENORRHAGIA AND MIGRAINE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE ESSURE DEVICES WERE PLACED IN STANDARD FASHION AND DEPLOYED AND EACH HAD ABOUT 5 COILS IN ENDOMETRIAL CAVITY. SHE IS CURRENTLY PLANNING FOR ESSURE REMOVAL. SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST (DISCREPANCY NOTED). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: COILS WERE PROPERLY PLACED CT ABDOMEN: IMPRESSION: MILD COLONIC WALL THICKENING, INCOMPLETE DISTENSION VERSUS NONSPECIFIC COLITIS. CLINICAL CORRELATION RECOMMENDED. SUBACUTE FRACTURE OF A RIGHT ANTERIOR RIB. BILATERAL TUBAL OCCLUSION. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD: MEDICAL DEVICE MONITORING ERROR. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-SEP-2018: UPDATE OF INFORMATION (BATCH IS INVALID). INCIDENT: NO VALID LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. THERE IS NO EVIDENCE THAT A DEVICE RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ("HEAVY MENSTRUAL BLEEDING/HEAVY BLEEDING") AND ADHESION ("LYSIS OF ADHESIONS") IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872572-NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ENDOMETRIAL ABLATION PERFORMED WITH ESSURE BILATERAL TUBAL STERILIZATIONS" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S MEDICAL HISTORY INCLUDED TACHYCARDIA, PELVIC PAIN FEMALE, DYSFUNCTIONAL UTERINE BLEEDING, UTERINE BLEEDING, PNEUMONIA AND KIDNEY INFECTION. CONCURRENT CONDITIONS INCLUDED BACK PAIN, LEG PAIN, PELVIC PERITONEAL ADHESIONS, FLANK PAIN, DYSURIA, VOMITING, CHILLS, FEVER, PYELONEPHRITIS AND UTI. CONCOMITANT PRODUCTS INCLUDED OXYCODONE HYDROCHLORIDE;PARACETAMOL (PERCOCET). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN"). IN (B)(6) 2014, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER ("CRAMPING/LOWER ABDOMEN PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN/PAIN"), BACK PAIN ("BACK PAIN") AND DYSPAREUNIA ("PAIN DURING INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ADHESION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH SURGERY (ABLATION DONE ON (B)(6) 2015/ LAPROSCOPY- LYSIS OF ADHESION AND LYSIS OF ADHESIONS). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN, BACK PAIN AND DYSPAREUNIA HAD NOT RESOLVED AND THE MIGRAINE, HEADACHE, DYSMENORRHOEA AND PELVIC PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, ADHESION, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, MENORRHAGIA, MIGRAINE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE ESSURE DEVICES WERE PLACED IN STANDARD FASHION AND DEPLOYED AND EACH HAD ABOUT 5 COILS IN ENDOMETRIAL CAVITY. SHE IS CURRENTLY PLANNING FOR ESSURE REMOVAL. SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST (DISCREPANCY NOTED) DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: RESULTS: COILS WERE PROPERLY PLACED. DIAGNOSTIC RESULTS: CT ABDOMEN: IMPRESSION: 1. MILD COLONIC WALL THICKENING, INCOMPLETE DISTENSION VERSUS NONSPECIFIC COLITIS. CLINICAL CORRELATION RECOMMENDED. 2. SUBACUTE FRACTURE OF A RIGHT ANTERIOR RIB. 3. BILATERAL TUBAL OCCLUSION ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD: MEDICAL DEVICE MONITORING ERROR. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-MAR-2019: PLAINTIFF FACT SHEET RECEIVED. REPORTER INFORMATION UPDATED. EVENT: PELVIC PAIN NEWLY ADDED. INCIDENT 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.
SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MENORRHAGIA ("HEAVY MENSTRUAL BLEEDING/HEAVY BLEEDING") IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 872572) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: MEDICAL DEVICE MONITORING ERROR "ENDOMETRIAL ABLATION PERFORMED WITH ESSURE BILATERAL TUBAL STERILIZATIONS" AND DEVICE MONITORING PROCEDURE NOT PERFORMED "SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED TACHYCARDIA, PELVIC PAIN FEMALE, DYSFUNCTIONAL UTERINE BLEEDING, UTERINE BLEEDING, PNEUMONIA AND KIDNEY INFECTION. CONCURRENT CONDITIONS INCLUDED BACK PAIN, LEG PAIN, PELVIC PERITONEAL ADHESIONS, FLANK PAIN, DYSURIA, VOMITING, CHILLS, FEVER, PYELONEPHRITIS AND UTI. CONCOMITANT PRODUCTS INCLUDED OXYCOCET (PERCOCET). ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2014, THE PATIENT EXPERIENCED MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN LOWER ("CRAMPING/LOWER ABDOMEN PAIN"), ABDOMINAL PAIN ("ABDOMINAL PAIN/PAIN"), BACK PAIN ("BACK PAIN") AND DYSPAREUNIA ("PAIN DURING INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2014, THE PATIENT EXPERIENCED MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION DONE ON (B)(6) 2015). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE MENORRHAGIA, ABDOMINAL PAIN LOWER, ABDOMINAL PAIN, BACK PAIN AND DYSPAREUNIA HAD NOT RESOLVED AND THE MIGRAINE, HEADACHE AND DYSMENORRHOEA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ABDOMINAL PAIN LOWER, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, HEADACHE, MENORRHAGIA AND MIGRAINE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE ESSURE DEVICES WERE PLACED IN STANDARD FASHION AND DEPLOYED AND EACH HAD ABOUT 5 COILS IN ENDOMETRIAL CAVITY. SHE IS CURRENTLY PLANNING FOR ESSURE REMOVAL. SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST (DISCREPANCY NOTED). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: COILS WERE PROPERLY PLACED. CT ABDOMEN: IMPRESSION: MILD COLONIC WALL THICKENING, INCOMPLETE DISTENSION VERSUS NONSPECIFIC COLITIS. CLINICAL CORRELATION: RECOMMENDED. SUBACUTE FRACTURE OF A RIGHT ANTERIOR RIB. BILATERAL TUBAL OCCLUSION CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORD: MEDICAL DEVICE MONITORING ERROR. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-AUG-2018: PFS RECEIVED: FOLLOWING EVENTS WERE ADDED: MIGRAINES, HEADACHES AND DYSMENORRHEA(CRAMPING) AND SHE DID NOT UNDERGO ESSURE CONFIRMATION TEST. EVENT TERM UPDATED: CRAMPING/LOWER ABDOMEN PAIN AND PAIN DURING INTERCOURSE/DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE). LOT NO. ADDED. INCIDENT: AT THE TIME OF REPORTING, THERE IS NO EVIDENCE THAT A DEVICE-RELATED DEFECT OR MALFUNCTION CAUSED A DEATH OR SERIOUS INJURY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 675063 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 872572-NOT VALID | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other| R | PERCOCET| PERCOCET| PERCOCET [OXYCODONE HYDROCHLORIDE,PARACETAMOL]| PERCOCET |