ESSURE
Report
- Report Number
- 2951250-2023-02449
- Event Type
- Injury
- Date Received
- May 24, 2023
- Date of Event
- March 8, 2016
- Report Date
- January 29, 2024
- 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
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("THE LEFT FALLOPIAN TUBE IA PATENT AND THE PRESSURE DEVICE IS LOCATED IN THE ENDOMETRIAL CANAL (ESSURE SLIPPED INTO ENDOMETRIUM)") IN A 26 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. C06520) FOR FEMALE STERILISATION. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE ("THE LEFT FALLOPIAN TUBE IA PATENT AND THE PRESSURE DEVICE IS LOCATED IN THE ENDOMETRIAL CANAL (ESSURE SLIPPED INTO ENDOMETRIUM)" ON (B)(6) 2016). THE PATIENT HAD A MEDICAL HISTORY OF MENORRHAGIA, SURGERY (COLONOSCOPY SCREENING (B)(6) 2021, EGD (B)(6) 2021, EXTRACTION, ERUPTED TOOTH OR EXPOSED ROOT (ELEVATION AND/OR FORCEPS REMOVAL) (B)(6) 2015, S SLING BLADDER (B)(6) 2016, TONSILLECTOMY HX (B)(6) 2015, TUBAL LIGATION HX (B)(6) 2016.), TEMPOROMANDIBULAR JOINT DISORDER, IRRITABLE BOWEL SYNDROME, FIBROMYALGIA, MIGRAINE WITHOUT AURA, ANEMIA, ATTENTION DEFICIT HYPERACTIVITY DISORDER, HEAVY MENSTRUAL BLEEDING, DIFFICULTY SLEEPING, PREGNANCY TEST NEGATIVE, ALLERGY (VICODIN: GI UPSET: SIDE EFFECTS), PAST TOBACCO SMOKING, HERPES SIMPLEX AND SEXUALLY TRANSMITTED DISEASE. THE PATIENT HAD A FAMILY HISTORY OF GRAVES' DISEASE AND BREAST CANCER. ON (B)(6) 2015, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 111 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED). ESSURE WAS REMOVED ON (B)(6) 2016. THE PATIENT WAS TREATED WITH SURGERY (ESSURE WITHIN THE UTERUS WAS REMOVED AND LAPAROSCOPIC BILATERAL TUBAL LIGATION & NOVASURE ABELATION). THE REPORTER COMMENTED: DISCREPANCY NOTED: SURGICAL PATHOLOGY REPORT DATE IS RECORDED AS 05-SEP-2023 AND PATIENT HAD SURGICAL PROCEDURE ON (B)(6) 2016. INSERTION DATE - AS PER ARGUS - (B)(6) 2015 AND AS PER MR - (B)(6) 2015. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [HYSTEROSALPINGOGRAM] ON (B)(6) 2016: HYSTEROSALPINGOGRAM. REASON FOR EXAM: ENCOUNTER FOR ESSURE IMPLANTATION. CLINICAL HISTORY: POST TUBAL OCCLUSION DEVICE PLACEMENT. POST ESSURE. FINDINGS: INITIAL IMAGES SHOW A TUBAL OEELUSION DEVICE IN THE RIGHT PELVIS AND A TUBAL OCCLUSION DEVICE LOCATED IN THE CENTRAL PELVIS. THE RIGHT FALLOPIAN TUBE IS OCCLUDED. THE LEFT FALLOPIAN TUBE IA PATENT AND THE PRESSURE DEVICE IS LOCATED IN THE ENDOMETRIAL CANAL. THERE IS FREE SPILL OF CONTRAST FROM THE LEFT FALLOPIAN TUBE. PATIENT TOLERATED THE PROCEDURE WELL WITH NO BILIARY COMPLICATIONS. IMPRESSION: 1. LEFT FALLOPIAN TUBE IS PATENT AND THE LEFT ESSURE DEVICE IS LOCATED IN THE ENDOMETRIAL CANAL. THA PATIENT WAS INSTRUCTED TO CONTINUE WITH BIRTH CONTROL PILLS. 2. RIGHT FALLOPIAN TUBA IS OCCLUDED WITH SATISFACTORY PLACEMENT OF THE ASHER DEVICE IN THE RIGHT FALLOPIAN TUBE [PATHOLOGY TEST] ON (B)(6) 2023: SURGICAL PATHOLOGY REPORT: SPECIMENS A FALLOPIAN TUBE RESECTION LEFT AND RIGHT, WITH ONE ESSURE DEVICE. FINAL DIAGNOSIS: A. FALLOPIAN TUBES, BILATERAL SALPINGECTOMY: - BILATERAL FALLOPIAN TUBES WITH NO SIGNIFICANT HISTOPATHOLOGIC ABNORMALITY. GROSS DESCRIPTION: THE SECOND FALLOPIAN TUBE MEASURING 5.5 IN LENGTH X 0.6 CM IN DIAMETER. ALSO RECEIVED IN THE SAME CONTAINER IS A PROXIMAL PORTION OF FALLOPIAN TUBE MEASURING 2.2 X 0.5 X 0.3 CM. AN ESSURE DEVICE IS IDENTIFIED WITHIN THE LUMEN. CLINICAL HISTORY PRE-OP DIAGNOSIS: ENCOUNTER FOR REMOVAL OF ESSURE. [ULTRASOUND SCAN] ON (B)(6) 2016: COMMENTS UTERUS HAS A HYPERECHOIC STRUCTURE WITHIN THE ENDOMETRIUM PROBABLE ESSURE SLIPPED INTO ENDOMERTRIUM. UTERUS ITSELF APPEARS WNL. BOTH OVARIES APPEAR WNL. NO FREE FLUID IS SEEN. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: DEVICE DISLOCATION. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 17-NOV-2023: MEDICAL RECORD RECEIVED. REPORTERS INFORMATION ADDED. PATIENT MEDICAL HISTORY AND LAB DATA ADDED INCLUDING PATHOLOGY TEST. LOT NUMBER ADDED .NON DRUG TREATMENT UPDATED. EVENT DEVICE MIGRATION ADDED. 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.
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 27 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2017 SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY - UTERUS). THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: IMPLANT STATE: OH REMOVAL STATE: OH. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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 AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: (B)(6) 2023: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF DEVICE EXPULSION ("THE LEFT FALLOPIAN TUBE IA PATENT AND THE PRESSURE DEVICE IS LOCATED IN THE ENDOMETRIAL CANAL (ESSURE SLIPPED INTO ENDOMETRIUM)") IN A 26 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. C06520) FOR FEMALE STERILISATION. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE ("THE LEFT FALLOPIAN TUBE IA PATENT AND THE PRESSURE DEVICE IS LOCATED IN THE ENDOMETRIAL CANAL (ESSURE SLIPPED INTO ENDOMETRIUM)" ON 08-MAR-2016). THE PATIENT HAD A MEDICAL HISTORY OF MENORRHAGIA, SURGERY (COLONOSCOPY SCREENING 29NOV2021, EGD JAN2021, EXTRACTION, ERUPTED TOOTH OR EXPOSED ROOT (ELEVATION AND/OR FORCEPS REMOVAL) 01JAN2015, S SLING BLADDER 01JAN2016, TONSILLECTOMY HX 01JAN2015, TUBAL LIGATION HX 01JAN2016.), TEMPOROMANDIBULAR JOINT DISORDER, IRRITABLE BOWEL SYNDROME, FIBROMYALGIA, MIGRAINE WITHOUT AURA, ANEMIA, ATTENTION DEFICIT HYPERACTIVITY DISORDER, HEAVY MENSTRUAL BLEEDING, DIFFICULTY SLEEPING, PREGNANCY TEST NEGATIVE, ALLERGY (VICODIN: GI UPSET: SIDE EFFECTS), PAST TOBACCO SMOKING, HERPES SIMPLEX AND SEXUALLY TRANSMITTED DISEASE. THE PATIENT HAD A FAMILY HISTORY OF GRAVES' DISEASE AND BREAST CANCER. ON 18-NOV-2015, THE PATIENT HAD ESSURE INSERTED. ON 08-MAR-2016, 111 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED). ESSURE WAS REMOVED ON 19-APR-2016. THE PATIENT WAS TREATED WITH SURGERY (ESSURE WITHIN THE UTERUS WAS REMOVED AND LAPAROSCOPIC BILATERAL TUBAL LIGATION & NOVASURE ABELATION). THE REPORTER CONSIDERED DEVICE EXPULSION TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: DISCREPANCY NOTED: SURGICAL PATHOLOGY REPORT DATE IS RECORDED AS 05-SEP-2023 AND PATIENT HAD SURGICAL PROCEDURE ON 19APR2016. INSERTION DATE - AS PER ARGUS - 01JAN2015 AND AS PER MR - 8-NOV-2015. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [HYSTEROSALPINGOGRAM] ON 08-MAR-2016: HYSTEROSALPINGOGRAM REASON FOR EXAM: ENCOUNTER FOR ESSURE IMPLANTATION CLINICAL HISTORY: POST TUBAL OCCLUSION DEVICE PLACEMENT. POST ESSURE. FINDINGS: INITIAL IMAGES SHOW A TUBAL OEELUSION DEVICE IN THE RIGHT PELVIS AND A TUBAL OCCLUSION DEVICE LOCATED IN THE CENTRAL PELVIS. THE RIGHT FALLOPIAN TUBE IS OCCLUDED. THE LEFT FALLOPIAN TUBE IA PATENT AND THE PRESSURE DEVICE IS LOCATED IN THE ENDOMETRIAL CANAL. THERE IS FREE SPILL OF CONTRAST FROM THE LEFT FALLOPIAN TUBE. PATIENT TOLERATED THE PROCEDURE WELL WITH NO BILIARY COMPLICATIONS. IMPRESSION: 1. LEFT FALLOPIAN TUBE IS PATENT AND THE LEFT ESSURE DEVICE IS LOCATED IN THE ENDOMETRIAL CANAL. THA PATIANT WAS INSTRUCTED TO CONTINUE WITH BIRTH CONTROL PILLS. 2. RIGHT FALLOPIAN TUBA IS OCELUDED WITH SATISFACTORY PLACEMENT OF THE ASHER DEVICE IN THE RIGHT FALLOPIAN TUBE [PATHOLOGY TEST] ON 05-SEP-2023: SURGICAL PATHOLOGY REPORT: SPECIMENS A FALLOPIAN TUBE RESECTION LEFT AND RIGHT, WITH ONE ESSURE DEVICE. FINAL DIAGNOSIS A. FALLOPIAN TUBES, BILATERAL SALPINGECTOMY: - BILATERAL FALLOPIAN TUBES WITH NO SIGNIFICANT HISTOPATHOLOGIC ABNORMALITY. GROSS DESCRIPTION: THE SECOND FALLOPIAN TUBE MEASURING 5.5 IN LENGTH X 0.6 CM IN DIAMETER. ALSO RECEIVED IN THE SAME CONTAINER IS A PROXIMAL PORTION OF FALLOPIAN TUBE MEASURING 2.2 X 0.5 X 0.3 CM. AN ESSURE DEVICE IS IDENTIFIED WITHIN THE LUMEN. CLINICAL HISTORY PRE-OP DIAGNOSIS: ENCOUNTER FOR REMOVAL OF ESSURE [ULTRASOUND SCAN] ON 08-MAR-2016: COMMENTS UTERUS HAS A HYPERECHOIC STRUCTURE WITHIN THE ENDOMETRIUM PROBABLE ESURE SLIPPED INTO ENDOMERTRIUM. UTERUS ITSELF APPEARS WNL. BOTH OVARIES APPEAR WNL. NO FREE FLUID IS SEEN. LOT NUMBER:C06520 MANUFACTURE DATE: 2013-12 EXPIRATION DATE: 2016-12. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: 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. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 29-JAN-2024: 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 ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 27 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2017 SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY - UTERUS). THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: IMPLANT STATE: (B)(6). REMOVAL STATE: (B)(6). QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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 AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 948459 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | C06520 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Female | Other| R |