ESSURE
Report
- Report Number
- 2951250-2023-01585
- Event Type
- Injury
- Date Received
- March 21, 2023
- Date of Event
- August 1, 2023
- Report Date
- November 2, 2023
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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 FALLOPIAN TUBE PERFORATION ("MEDICAL DEVICE REMOVAL / POSSIBLE PERFORATION OF ESSURE COIL ON LEFT POSTERIOR UTERUS") IN A 44 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 801328-INVALID) FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF ADENOMYOSIS, APPENDECTOMY, ENDOMETRIAL ABLATION, CHOLECYSTECTOMY, MIGRAINE, DIARRHEA, VAGINAL BLEEDING, GERD, CHOLELITHIASIS, PREVIOUS CAESAREAN SECTION, RIGHT LOWER QUADRANT PAIN, DYSMENORRHOEA, MENORRHAGIA AND PELVIC PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: MIRENA. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2023, 4206 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY TOTAL ABDOMINAL LAPAROSCOPY BILATERAL SALPINGECTOMY, CYSTOSCOPY). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED FALLOPIAN TUBE PERFORATION TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: MORE THAN ONE ESSURE RELATED SURGERY: NO REMOVAL DATE AS REPORTED : (B)(6) 2023 DISCREPANCY NOTED : INSERTION DATE AS PER ARGUS (B)(6) 2012 AS PER MR : (B)(6) 2012 DISCREPANCY NOTED : REMOVAL DATE AS PER ARGUS (B)(6) 2023 AS PER MR : :(B)(6) 2023. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [PATHOLOGY TEST] ON (B)(6) 2023: UTERUS AND CERVIX, BILATERAL FALLOPIAN TUBES, HYSTERECTOMY WITH BILATERAL SALPINGECTOMY: - UTERINE SEROSAL FIBROVASCULAR ADHESIONS. - CERVIX WITH NO SIGNIFICANT HISTOPATHOLOGIC ABNORMALITY. - ENDOMETRIAL CAVITY LINED BY FIBROSIS WITH PATCHES OF BENIGN SECRETORY PATTERN ENDOMETRIUM, CONSISTENT WITH HISTORY OF PREVIOUS ABLATION. - ADENOMYOSIS WITH FOCAL CYSTIC CHANGE. - BENIGN FALLOPIAN TUBES WITH NO SIGNIFICANT HISTOPATHOLOGIC ABNORMALITY. PRE-OPERATIVE DIAGNOSIS: IRREGULAR CYCLES, PRIOR ABLATION POST-OPERATIVE DIAGNOSIS: : IRREGULAR CYCLES, PRIOR ABLATION UTERUS, CERVIX, BILATERAL FALLOPIAN TUBES ADDITIONAL FEATURES/COMMENTS: IDENTIFIED WITHIN BOTH CORNUA OF THE UTERUS ARE COILED PORTIONS OF METAL POSSIBLY CONSISTENT WITH MIRENA.(AS WRITTEN) ACCORDING TO BAYER QA BATCH. NO - 801328 IS INVALID. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 30-OCT-2023: UPDATE OF INFORMATION (BATCH IS INVALID). AN INVALID LOT NUMBER WAS RECEIVED IN THIS CASE. 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 FALLOPIAN TUBE PERFORATION ("MEDICAL DEVICE REMOVAL / POSSIBLE PERFORATION OF ESSURE COIL ON LEFT POSTERIOR UTERUS") IN A 44 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 801328) FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF ADENOMYOSIS, APPENDECTOMY, ENDOMETRIAL ABLATION, CHOLECYSTECTOMY, MIGRAINE, DIARRHEA, VAGINAL BLEEDING, GERD, CHOLELITHIASIS, PREVIOUS CAESAREAN SECTION, RIGHT LOWER QUADRANT PAIN, DYSMENORRHOEA, MENORRHAGIA AND PELVIC PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: MIRENA. ON 25-JAN-2012, THE PATIENT HAD ESSURE INSERTED. ON 01-AUG-2023, 4206 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY TOTAL ABDOMINAL LAPAROSCOPY BILATERAL SALPINGECTOMY, CYSTOSCOPY). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED FALLOPIAN TUBE PERFORATION TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: MORE THAN ONE ESSURE RELATED SURGERY: NO REMOVAL DATE AS REPORTED : 01-APR-2023 DISCREPANCY NOTED : INSERTION DATE AS PER ARGUS 01-JAN-2012 AS PER MR : 25JAN2012 DISCREPANCY NOTED : REMOVAL DATE AS PER ARGUS 28-APR-2023 AS PER MR : :01AUG2023. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [PATHOLOGY TEST] ON 01-AUG-2023: UTERUS AND CERVIX, BILATERAL FALLOPIAN TUBES, HYSTERECTOMY WITH BILATERAL SALPINGECTOMY: - UTERINE SEROSAL FIBROVASCULAR ADHESIONS. - CERVIX WITH NO SIGNIFICANT HISTOPATHOLOGIC ABNORMALITY. - ENDOMETRIAL CAVITY LINED BY FIBROSIS WITH PATCHES OF BENIGN SECRETORY PATTERN ENDOMETRIUM, CONSISTENT WITH HISTORY OF PREVIOUS ABLATION. - ADENOMYOSIS WITH FOCAL CYSTIC CHANGE. - BENIGN FALLOPIAN TUBES WITH NO SIGNIFICANT HISTOPATHOLOGIC ABNORMALITY. PRE-OPERATIVE DIAGNOSIS: IRREGULAR CYCLES, PRIOR ABLATION POST-OPERATIVE DIAGNOSIS: : IRREGULAR CYCLES, PRIOR ABLATION UTERUS, CERVIX, BILATERAL FALLOPIAN TUBES ADDITIONAL FEATURES/COMMENTS: IDENTIFIED WITHIN BOTH CORNUA OF THE UTERUS ARE COILED PORTIONS OF METAL POSSIBLY CONSISTENT WITH MIRENA.(AS WRITTEN) THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 29-SEP-2023: MR RECEIVED :EVENT "MEDICAL DEVICE REMOVAL UPDATED TO FALLOPIAN TUBE PERFORATION" LOT NUMBER ADDED, REPORTERS INFORMATION PATIENT MEDICAL HISTORY AND SURGICAL PATHOLOGY REPORTS WERE ADDED. PRODUCT INSERTION REMOVAL DATE AND RCC UPDATED. 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 44 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. AN UNKNOWN TIME LATER SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: MORE THAN ONE ESSURE RELATED SURGERY: NO. REMOVAL DATE AS REPORTED: (B)(6) 2023. 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: 18-APR-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 AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 44 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. AN UNKNOWN TIME LATER SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: MORE THAN ONE ESSURE RELATED SURGERY: NO. REMOVAL DATE AS REPORTED: (B)(6) 2023. 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 WILL BE 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 |
|---|---|---|---|---|---|---|---|
| 356231 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 801328-INVALID | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Female | Required Intervention |