ESSURE
Report
- Report Number
- 2951250-2023-01388
- Event Type
- Injury
- Date Received
- March 19, 2023
- Date of Event
- November 17, 2017
- Report Date
- December 28, 2023
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, 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 MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 34 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 880433) FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF COLONOSCOPY, CHOLECYSTECTOMY, BACK PAIN, DYSPAREUNIA, LEFT LOWER QUADRANT PAIN, HEAVY PERIODS, ABORTION, PERINEAL PAIN, BLOATING, PELVIC PAIN FEMALE, PARITY 2, MULTIGRAVIDA, TOBACCO USER, CHOLECYSTECTOMY AND HEADACHE. THE PATIENT HAD A FAMILY HISTORY OF BREAST CANCER, CERVICAL CANCER AND OVARIAN CANCER. CONCURRENT CONDITIONS WERE LISTED AS VAGINAL BLEEDING AND ABNORMAL UTERINE BLEEDING. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2017, 2200 DAYS AFTER ESSURE INSERTION, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). 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. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [HYSTEROSALPINGOGRAM] ON (B)(6) 2012: IMPRESSION: 1. BILATERAL FALLOPIAN TUBES ARE OCCLUDED AND DEMONSTRATE NO CONTRAST FLOW PAST THE ESSURE DEVICES. 2. NORMAL UTERINE CAVITY CONTOURS. FINDINGS: THE ENDOMETRIAL CAVITY FILLS NORMALLY AND DEMONSTRATES NORMAL SMOOTH CONTOURS WITHOUT EVIDENCE OF POLYP OR OTHER PERSISTENT FOCAL ABNORMALITY OR FILLING DEFECT. UNDER LOW PRESSURE FILLING, THE FALLOPIAN TUBES DEMONSTRATE NO SPILLAGE OF CONTRAST PAST THE ESSURE DEVICES. THE CLOSEST AND AS THE ESSURE DEVICES ARE WITHIN 1.5 CM AT THE UTERINE CORNUA. BILATERAL FALLOPIAN TUBES ARE OCCLUDED. REAL-TIME IMAGING DEMONSTRATES NO CONTRAST SPILLAGE FROM BILATERAL FALLOPIAN TUBES. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO IMMEDIATE COMPLICATIONS [ULTRASOUND PELVIS] ON (B)(6) 2017: FINDINGS: FALLOPIAN OCCLUSIVE (ESSURE) DEVICES ARE PARTIALLY VISUALIZED. IMPRESSION: SMALL RESOLVING HEMORRHAGIC FOLLICLE MEASURING 2.3 CM AT THE LEFT OVARY, OTHERWISE UNREMARKABLE PELVIC ULTRASOUND. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 31-OCT-2023: MEDICAL RECORD RECEIVED. LOT NUMBER , LAB DATA, MEDICAL HISTORY , CONCOMITANT CONDITIONS & REPORTER INFORMATION 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 34 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) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2017, 2200 DAYS AFTER ESSURE INSERTION, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL SURGERY). 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. 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: 14-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 (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 34 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 880433) FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF COLONOSCOPY, CHOLECYSTECTOMY, BACK PAIN, DYSPAREUNIA, LEFT LOWER QUADRANT PAIN, HEAVY PERIODS, ABORTION, PERINEAL PAIN, BLOATING, PELVIC PAIN FEMALE, PARITY 2, MULTIGRAVIDA, TOBACCO USER, CHOLECYSTECTOMY AND HEADACHE. THE PATIENT HAD A FAMILY HISTORY OF BREAST CANCER, CERVICAL CANCER AND OVARIAN CANCER. CONCURRENT CONDITIONS WERE LISTED AS VAGINAL BLEEDING AND ABNORMAL UTERINE BLEEDING. ON (B)(6)2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2017, 2200 DAYS AFTER ESSURE INSERTION, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). 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. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [HYSTEROSALPINGOGRAM] ON (B)(6) 2012: IMPRESSION: 1. BILATERAL FALLOPIAN TUBES ARE OCCLUDED AND DEMONSTRATE NO CONTRAST FLOW PAST THE ESSURE DEVICES. 2. NORMAL UTERINE CAVITY CONTOURS. FINDINGS: THE ENDOMETRIAL CAVITY FILLS NORMALLY AND DEMONSTRATES NORMAL SMOOTH CONTOURS WITHOUT EVIDENCE OF POLYP OR OTHER PERSISTENT FOCAL ABNORMALITY OR FILLING DEFECT. UNDER LOW PRESSURE FILLING, THE FALLOPIAN TUBES DEMONSTRATE NO SPILLAGE OF CONTRAST PAST THE ESSURE DEVICES. THE CLOSEST AND AS THE ESSURE DEVICES ARE WITHIN 1.5 CM AT THE UTERINE CORNUA. BILATERAL FALLOPIAN TUBES ARE OCCLUDED. REAL-TIME IMAGING DEMONSTRATES NO CONTRAST SPILLAGE FROM BILATERAL FALLOPIAN TUBES. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO IMMEDIATE COMPLICATIONS [ULTRASOUND PELVIS] ON (B)(6) 2017: FINDINGS: FALLOPIAN OCCLUSIVE (ESSURE) DEVICES ARE PARTIALLY VISUALIZED. IMPRESSION: SMALL RESOLVING HEMORRHAGIC FOLLICLE MEASURING 2.3 CM AT THE LEFT OVARY, OTHERWISE UNREMARKABLE PELVIC ULTRASOUND. 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: 28-DEC-2023: 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 34 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)2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2017, 2200 DAYS AFTER ESSURE INSERTION, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL SURGERY). 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. 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 |
|---|---|---|---|---|---|---|---|
| 362011 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 880433 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Female | Required Intervention |