ESSURE
Report
- Report Number
- 2951250-2023-02485
- Event Type
- Injury
- Date Received
- May 25, 2023
- Date of Event
- September 17, 2021
- Report Date
- January 9, 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 MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 35 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 915884) FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF ANEMIA, DEPRESSION, ALCOHOL USE, PREMATURE DELIVERY, HYPOTHYROIDISM, BLOOD PRESSURE HIGH, VAGINAL PAIN, ANXIETY, ANEMIA, OVARIAN CYST, ENDOMETRIOSIS, ADENOMYOSIS, STRESS URINARY INCONTINENCE, ABORTION, SMOKER (SMOKES 5 CIGARETTES PER MONTH), ECTOPIC PREGNANCY, ENDOMETRITIS, MIGRAINE, VAGINAL ITCHING, DYSURIA, BACTERIAL VAGINOSIS, MIGRAINE, PARITY 4, MULTI GRAVIDA AND PELVIC PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: MIRENA, ORAL CONTRACEPTIVE NOS AND PARAGARD. THE PATIENT HAD A FAMILY HISTORY OF OVARIAN CANCER AND CERVICAL CANCER. CONCOMITANT PRODUCTS INCLUDED NALOXONE AND IBUPROFEN. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2021, 3349 DAYS AFTER ESSURE INSERTION AND 153 DAYS AFTER ITS MOST RECENT USE, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY AND A RIGHT SALPINGECTOMY AND CYSTOSCOPY). 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. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [PATHOLOGY TEST] ON (B)(6) 2020: FINAL MICROSCOPIC PATHOLOGIC DIAGNOSIS: FALLOPIAN TUBE, LEFT, SALPINGECTOMY: SURGICALLY TRANSECTED FALLOPIAN TUBE WITH INTRATUBAL FOREIGN BODY. CONTRACEPTIVE DEVICE; NEGATIVE FOR MALIGNANCY. GROSS DESCRIPTION: LEFT FALLOPIAN TUBE: AT THE SURGICAL MARGIN OF THE TUBE THERE IS A COILED WIRE DEVICE CONSISTENT WITH AN ESSURE DEVICE MEASURING 0.5 CM IN LENGTH. SEPARATE IN THE CONTAINER IS AN ADDITIONAL COILED WIRE CONSISTENT WITH ESSURE MEASURING 1.9 CM IN LENGTH. TWO CROSS SECTIONS ARE SUBMITTED ALONG WITH THE ENTIRE FIMBRIA; ON (B)(6) 2021: SPECIMEN RECEIVED: UTERUS, CERVIX AND RIGHT TUBE. FINAL MICROSCOPIC PATHOLOGY DIAGNOSIS: UTERUS, FALLOPIAN TUBE, HYSTERECTOMY AND RIGHT SALPINGECTOMY: UTERINE WEIGHT: 93 GRAMS. CERVIX / ENDOCERVIX: NO SIGNIFICANT HISTOPATHOLOGIC CHANGES. ENDOMETRIUM: SECRETORY PATTERN. MYOMETRIUM: NO SIGNIFICANT HISTOPATHOLOGIC CHANGES. RIGHT FALLOPIAN TUBE: NO SIGNIFICANT HISTOPATHOLOGIC CHANGES. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: ` THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 13-SEP-2023: MEDICAL RECORD RECEIVED. LOT NUMBER, SURGICAL PATHOLOGY REPORT ADDED, MEDICAL HISTORY , HISTORICAL DRUG ADDED. PATIENT & REPORTER 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 34 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6), 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6), 2021, 3090 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 - UTERUS). 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. 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 MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 35 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 915884) FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF ANEMIA, DEPRESSION, ALCOHOL USE, PREMATURE DELIVERY, HYPOTHYROIDISM, BLOOD PRESSURE HIGH, VAGINAL PAIN, ANXIETY, ANEMIA, OVARIAN CYST, ENDOMETRIOSIS, ADENOMYOSIS, STRESS URINARY INCONTINENCE, RECURRENT ABORTION, SMOKER (SMOKES 5 CIGARETTES PER MONTH), ECTOPIC PREGNANCY, ENDOMETRITIS, MIGRAINE, VAGINAL ITCHING, DYSURIA, BACTERIAL VAGINOSIS, MIGRAINE, PARITY 4, MULTI GRAVIDA AND PELVIC PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: MIRENA, ORAL CONTRACEPTIVE NOS AND PARAGARD. THE PATIENT HAD A FAMILY HISTORY OF OVARIAN CANCER AND CERVICAL CANCER. CONCOMITANT PRODUCTS INCLUDED NALOXONE AND IBUPROFEN. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2021, 3349 DAYS AFTER ESSURE INSERTION AND 153 DAYS AFTER ITS MOST RECENT USE, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (TOTAL LAPAROSCOPIC HYSTERECTOMY AND A RIGHT SALPINGECTOMY AND CYSTOSCOPY). 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. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [PATHOLOGY TEST] ON (B)(6) 2020: FINAL MICROSCOPIC PATHOLOGIC DIAGNOSIS: FALLOPIAN TUBE, LEFT, SALPINGECTOMY: SURGICALLY TRANSECTED FALLOPIAN TUBE WITH INTRATUBAL FOREIGN BODY CONTRACEPTIVE DEVICE; NEGATIVE FOR MALIGNANCY. GROSS DESCRIPTION: LEFT FALLOPIAN TUBE: AT THE SURGICAL MARGIN OF THE TUBE THERE IS A COILED WIRE DEVICE CONSISTENT WITH AN ESSURE DEVICE MEASURING 0.5 CM IN LENGTH. SEPARATE IN THE CONTAINER IS AN ADDITIONAL COILED WIRE CONSISTENT WITH ESSURE MEASURING 1.9 CM IN LENGTH. TWO CROSS SECTIONS ARE SUBMITTED ALONG WITH THE ENTIRE FIMBRIA; ON (B)(6) 2021: SPECIMEN RECEIVED: UTERUS, CERVIX AND RIGHT TUBE. FINAL MICROSCOPIC PATHOLOGY DIAGNOSIS: UTERUS, FALLOPIAN TUBE, HYSTERECTOMY AND RIGHT SALPINGECTOMY: UTERINE WEIGHT: 93 GRAMS. CERVIX / ENDOCERVIX: NO SIGNIFICANT HISTOPATHOLOGIC CHANGES. ENDOMETRIUM: SECRETORY PATTERN. MYOMETRIUM: NO SIGNIFICANT HISTOPATHOLOGIC CHANGES. RIGHT FALLOPIAN TUBE: NO SIGNIFICANT HISTOPATHOLOGIC CHANGES 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: 09-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 34 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2021, 3090 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 - UTERUS). 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. 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 |
|---|---|---|---|---|---|---|---|
| 1516300 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 915884 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Female | Required Intervention | IBUPROFEN| IBUPROFEN| NALOXONE| NALOXONE |