ESSURE
Report
- Report Number
- 2951250-2019-09694
- Event Type
- Injury
- Date Received
- October 7, 2019
- Date of Event
- October 1, 2018
- Report Date
- January 16, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- 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 DISLOCATION ('MIGRATION OF ESSURE LOCATION OF DEVICE: COULD NOT BE FOUND') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 2222096) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GALLBLADDER REMOVAL, PARATUBAL CYST, CARPAL TUNNEL RELEASE, DIABETES, HYPERTENSION, HEART DISEASE, UNSPECIFIED, UTERINE BLEEDING, DYSFUNCTIONAL UTERINE BLEEDING, HYPERLIPIDEMIA AND GERD. CONCURRENT CONDITIONS INCLUDED MENOMETRORRHAGIA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND RANITIDINE HYDROCHLORIDE (ZANTAC). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2010, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2010, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("MENORRHAGIA"). IN (B)(6) 2018, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH UNILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION AND DYSMENORRHOEA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA AND DYSPAREUNIA HAD RESOLVED. THE REPORTER CONSIDERED DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE DEVICE WAS PLACED WITHOUT ANY DIFFICULTY, AT THIS TIME WITH APPROXIMATELY 3 OR 4 COILS NOTED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2010: FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBES; ON (B)(6)2010: TOTAL BILATERAL OCCLUSION. PATHOLOGY TEST - ON (B)(6) 2018: UTERUS, CERVIX AND RIGHT FALLOPIAN TUBE": A UTERINE BODY WITH ATTACHED CERVIX AND SEPARATE FALLOPIAN TUBE. THE FALLOPIAN TUBE IS 3.5 CM IN LENGTH BY UP TO 0.5 CM IN DIAMETER. THERE IS FIMBRIA PRESENT AT ONE END OF THE SPECIMEN ALONG WITH A 1 CM IN GREATEST DIMENSION SEROUS FLUID FILLED PARATUBAL CYST. IN THE CORNU OF THE UTERUS THERE ARE TWO SILVER COILS GROSSLY CONSISTENT WITH ESSURE DEVICES. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-DEC-2019: PFS RECEIVED LOT NUMBER WAS ADDED. MEDICAL HISTORY, REPORTER INFORMATION WERE ADDED. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH 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 OF ESSURE LOCATION OF DEVICE: COULD NOT BE FOUND') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO: 2222096- NOT VALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GALLBLADDER REMOVAL, PARATUBAL CYST, CARPAL TUNNEL RELEASE, DIABETES, HYPERTENSION, HEART DISEASE, UNSPECIFIED, UTERINE BLEEDING, DYSFUNCTIONAL UTERINE BLEEDING, HYPERLIPIDEMIA AND GERD. CONCURRENT CONDITIONS INCLUDED MENOMETRORRHAGIA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND RANITIDINE HYDROCHLORIDE (ZANTAC). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2010, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). ON (B)(6) 2010, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("MENORRHAGIA"). ON (B)(6) 2018, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH UNILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION AND DYSMENORRHOEA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA AND DYSPAREUNIA HAD RESOLVED. THE REPORTER CONSIDERED DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE DEVICE WAS PLACED WITHOUT ANY DIFFICULTY, AT THIS TIME WITH APPROXIMATELY 3 OR 4 COILS NOTED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM: ON (B)(6) 2010: FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBES; ON (B)(6)2010: TOTAL BILATERAL OCCLUSION. PATHOLOGY TEST: ON (B)(6) 2018: UTERUS, CERVIX AND RIGHT FALLOPIAN TUBE": A UTERINE BODY WITH ATTACHED CERVIX AND SEPARATE FALLOPIAN TUBE. THE FALLOPIAN TUBE IS 3.5 CM IN LENGTH BY UP TO 0.5 CM IN DIAMETER. THERE IS FIMBRIA PRESENT AT ONE END OF THE SPECIMEN ALONG WITH A 1 CM IN GREATEST DIMENSION SEROUS FLUID FILLED PARATUBAL CYST. IN THE CORNU OF THE UTERUS THERE ARE TWO SILVER COILS GROSSLY CONSISTENT WITH ESSURE DEVICES. LOT NUMBER REPORTED 2222096 IS INVALID. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JAN-2020: UPDATE OF INFORMATION (BATCH IS NOT VALID). 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 OF ESSURE LOCATION OF DEVICE: COULD NOT BE FOUND') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED GALLBLADDER REMOVAL AND PARATUBAL CYST. CONCURRENT CONDITIONS INCLUDED MENOMETRORRHAGIA. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) AND RANITIDINE HYDROCHLORIDE (ZANTAC). ON (B)(6) 2010, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2010, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING),") AND DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE)"). IN (B)(6) 2010, THE PATIENT EXPERIENCED PELVIC PAIN ("PELVIC PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("MENORRHAGIA"). IN (B)(6) 2018, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH UNILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION AND DYSMENORRHOEA OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA AND DYSPAREUNIA HAD RESOLVED. THE REPORTER CONSIDERED DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: ESSURE DEVICE WAS PLACED WITHOUT ANY DIFFICULTY, AT THIS TIME WITH APPROXIMATELY 3 OR 4 COILS NOTED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM ON (B)(6) 2010: FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBES; ON (B)(6) 2010: TOTAL BILATERAL OCCLUSION. PATHOLOGY TEST - ON (B)(6) 2018: UTERUS, CERVIX AND RIGHT FALLOPIAN TUBE": A UTERINE BODY WITH ATTACHED CERVIX AND SEPARATE FALLOPIAN TUBE. THE FALLOPIAN TUBE IS 3.5 CM IN LENGTH BY UP TO 0.5 CM IN DIAMETER. THERE IS FIMBRIA PRESENT AT ONE END OF THE SPECIMEN ALONG WITH A 1 CM IN GREATEST DIMENSION SEROUS FLUID FILLED PARATUBAL CYST. IN THE CORNU OF THE UTERUS THERE ARE TWO SILVER COILS GROSSLY CONSISTENT WITH ESSURE DEVICES. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-SEP-2019: PFS AND MR RECEIVED. REPORTERS INFORMATION UPDATED. EVENT: INJURY WERE UPDATED TO ABNORMAL BLEEDING (VAGINAL). NEW EVENT'S: MENORRHAGIA), DYSMENORRHEA (CRAMPING), DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE), MIGRATION OF ESSURE LOCATION OF DEVICE: COULD NOT BE FOUND, PAIN: PELVIC WERE ADDED. MEDICAL HISTORY, LAB DATA, CONCOMITANT DRUGS, WERE 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 INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 956758 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 2222096-NOTVALID | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Other| R | DEPO-PROVERA| DEPO-PROVERA| DEPO-PROVERA| ZANTAC| ZANTAC| ZANTAC |