ESSURE
Report
- Report Number
- 2951250-2023-02288
- Event Type
- Injury
- Date Received
- May 23, 2023
- Date of Event
- March 10, 2016
- Report Date
- January 4, 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 AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 32 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. 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) 2016 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. 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: 12-JUN-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 32 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 841528) FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF ABNORMAL UTERINE BLEEDING, INTERMENSTRUAL BLEEDING, MENSES PAINFUL, PELVIC PAIN, UTERINE FIBROID, PARITY 2, GRAVIDA II, UTERUS ENLARGED AND OBESITY. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY - UTERUS,BILATERAL SALPINGECTOMY). THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: NO. OF COILS: LEFT = 6, RIGHT = 2. THE UTERUS DISPLACED TO THE PATIENT'S RIGHT SIDE, THE FALLOPIAN TUBE WAS COAGULATED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX: 41.593 KG/SQM. [PATHOLOGY TEST] ON (B)(6) 2016: BOTH MEASURE 2.5 CM IN LENGTH X 0.6 CM IN DIAMETER AND CONTAIN SILVER METALLIC COIL RESEMBLING AN ESSURE DEVICE. ONE FALLOPIAN TUBE WITH PARA TUBAL CYST; T, THE OTHER FALLOPIAN TUBE WITH LARGER PARA TUBAL CYST. [ULTRASOUND PELVIS] ON (B)(6) 2015: UTERUS HETEROGENEOUSLY ENLARGED MEASURING 13.9 X 7.3 X 7.1 CM WITH AT LEAST 2 DISCRETE FIBROIDS, LARGEST MEASURING 5.6 CM WITHIN THE POSTERIOR FUNDUS. ENDOMETRIAL COMPLEX WAS 5 MM. RIGHT OVARY MEASURED 3.1X2.5X2.1 CM. LEFT OVARY MEASURED 3.4X 26 X 2.0 CM. [ULTRASOUND SCAN VAGINA] ON (B)(6) 2011: UTERUS - ANTEVERTED, ENLARGED W/ONE 1.5CM FIBROID, BILATERAL ESSURE. COILS ARE CONFIRMED IN PLACE ON THE 3D CORONAL VIEW. ENDOMETRIUM: 5.7MM, NO FOCAL MASS. RT OVARY: NORMAL. LT OVARY: NORMAL. ADNEXAE: NO MASS. CUL DE SAC: NO FREE FLUID. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 07-NOV-2023: REPORTERS, PATIENT INFORMATION, MEDICAL HISTORY, LAB DATA, INDICATION, LOT NO., REMOVAL DATE, EVNT ONSET DATE, AND NON DRUG TREATMENT 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 (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 32 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 841528) FOR PERMANENT CONTRACEPTIVE TUBAL IMPLANT. THE PATIENT HAD A MEDICAL HISTORY OF ABNORMAL UTERINE BLEEDING, INTERMENSTRUAL BLEEDING, MENSES PAINFUL, PELVIC PAIN, UTERINE FIBROID, PARITY 2, GRAVIDA II, UTERUS ENLARGED AND OBESITY. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016 SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY - UTERUS,BILATERAL SALPINGECTOMY). THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: NO. OF COILS: LEFT = 6, RIGHT = 2 THE UTERUS DISPLACED TO THE PATIENT'S RIGHT SIDE, THE FALLOPIAN TUBE WAS COAGULATED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX: 41.593 KG/SQM. [PATHOLOGY TEST] ON (B)(6) 2016: BOTH MEASURE 2.5 CM IN LENGTH X 0.6 CM IN DIAMETER AND CONTAIN SILVER METALLIC COIL RESEMBLING AN ESSURE DEVICE. ONE FALLOPIAN TUBE WITH PARA TUBAL CYST; T, THE OTHER FALLOPIAN TUBE WITH LARGER PARA TUBAL CYST [ULTRASOUND PELVIS] ON (B)(6) 2015: UTERUS HETEROGENEOUSLY ENLARGED MEASURING 13.9 X 7.3 X 7.1 CM WITH AT LEAST 2 DISCRETE FIBROIDS, LARGEST MEASURING 5.6 CM WITHIN THE POSTERIOR FUNDUS. ENDOMETRIAL COMPLEX WAS 5 MM. RIGHT OVARY MEASURED 3.1X2.5X2.1 CM. LEFT OVARY MEASURED 3.4X 26 X 2.0 CM [ULTRASOUND SCAN VAGINA] ON (B)(6) 2011: UTERUS - ANTEVERTED, ENLARGED W/ONE 1.5CM FIBROID, BILATERAL ESSURE COILS ARE CONFIRMED IN PLACE ON THE 3D CORONAL VIEW. ENDOMETRIUM - 5.7MM, NO FOCAL MASS. RT OVARY - NORMAL. LT OVARY - NORMAL. ADNEXAE - NO MASS. CUL DE SAC - NO FREE FLUID LOT NUMBER: 841528 MANUFACTURE DATE: 2011-11 EXPIRATION DATE: 2014-11. 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: 04-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 32 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. 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) 2016 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 |
|---|---|---|---|---|---|---|---|
| 257802 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841528 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Female | Required Intervention |