ESSURE
Report
- Report Number
- 2951250-2023-02384
- Event Type
- Injury
- Date Received
- May 24, 2023
- Date of Event
- September 1, 2015
- Report Date
- January 30, 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 29 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. C06468, REF306) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE ("PREGNANT WITH ESSURE MICRO-INSERT") AND DEVICE MONITORING PROCEDURE NOT PERFORMED ("REPORTS IN PAST HAD ESSURE DONE, BUT NO FOLLOWING HYSTEROSALPINGOGRAM"). THE PATIENT HAD A MEDICAL HISTORY OF DYSURIA, PAPANICOLAOU SMEAR NORMAL, LIGAMENT PAIN, ALLERGY (ALLERGIES: NO KNOWN DRUG ALLERGIES FOOD ALLERGIES: KIWI, CANTALOPE, HONEYDEW MELON - ITCHY THROAT ALSO ALLERGIC TO HAND SANITIZER ¿ RASH), MIGRAINE HEADACHE, MUSCLE STRAIN AND OBESITY. R HROB DUE TO PREVIA AND DESIRES BILATERAL SALPINGECTOMY WHEN C/S DONE. EDC(B)(6) 2015, SO WILL SCHEDULE C/S WITH BILATERAL SALPINGECTOMY (B)(6) 2015 SHE OFFERS NO C/O, RARE BRAXTON HICKS CONTRACTION, REPORTS (+)FM. REPORTS IN PAST HAD ESSURE DONE, BUT NO FOLLOWING HYSTEROSALPINGOGRAM THEN GOT PREGNANT. DEFINITELY DESIRES NO FUTURE FERTILITY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: CALCIUM, PNV, FISH OIL, PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS] AND MIRENA. THE PATIENT HAD A FAMILY HISTORY OF TWIN PREGNANCY (TWIN WITH AUTISM), HEPATITIS AND TYPE 2 DIABETES MELLITUS. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, 369 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY WITH CONTRACEPTIVE DEVICE"). ON (B)(6) 2015 SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED ON (B)(6) 2015. THE PATIENT WAS TREATED WITH SURGERY (1. MINILAPAROTOMY . 2. BILATERAL FIMBRIECTOMY.). AT THE TIME OF THE REPORT, THE OUTCOMES FOR MEDICAL DEVICE REMOVAL AND PREGNANCY WITH CONTRACEPTIVE DEVICE WERE UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD WAS ON (B)(6) 2014 AND THE ESTIMATED DATE OF DELIVERY WAS ON (B)(6) 2014. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH OF A HEALTHY CHILD. THE DELIVERY OCCURRED ON AN UNKNOWN DATE. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX: 31.221 KG/SQM. [PATHOLOGY TEST] ON (B)(6) 2015: SURGICAL PATHOLOGY REPORT: SPECIMENS SUBMITTED: A. RIGHT FALLOPIAN TUBE B. LEFT FALLOPIAN TUBE DIAGNOSIS: A. RIGHT FALLOPIAN TUBE; STERILIZATION: COMPLETE CROSS-SECTION OF BENIGN FALLOPIAN TUBE B. LEFT FALLOPIAN TUBE; STERILIZATION: COMPLETE CROSS-SECTION OF BENIGN FALLOPIAN TUBECLINICAL INFORMATION: BILATERAL SALPINGECTOMY, DESIRES PERMANENT STERILIZATION. GROSS DESCRIPTION: RIGHT FALLOPIAN TUBE: FIMBRIATED FALLOPIAN TUBE WITH AN ATTACHED 1.0 CM SESSILE PARATUBAL CYST LEFT FALLOPIAN TUBE: FIMBRIATED FALLOPIAN TUBE WITH A 1.0 CM ATTACHED SESSILE PARATUBAL CYST. [ULTRASOUND SCAN] ON (B)(6) 2015: TRANSABDOMINAL OBSTETRIC FETAL ULTRASOUND RESULTS:THERE IS A SINGLE LIVE INTRAUTERINE PREGNANCY IN CEPHALIC PRESENTATION. M-MODE IMAGING REVEALED A HEART RATE OF 150 BEATS PER MINUTE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: PREGNANCY WITH CONTRACEPTIVE DEVICE (10063130) AND DRUG INEFFECTIVE (10013709). THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 15-NOV-2023: MEDICAL RECORD RECEIVED. REPORTERS INFORMATION ADDED. PATIENT MEDICAL HISTORY AND LAB DATA ADDED INCLUDING PATHOLOGY TEST. LOT NUMBER AND EXPIRY DATE ADDED .NON DRUG TREATMENT UPDATED. EVENTS PREGNANCY WITH CONTRACEPTIVE DEVICE AND DRUG INEFFECTIVE 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 29 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. C06468) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE INEFFECTIVE ("PREGNANT WITH ESSURE MICRO-INSERT") AND DEVICE MONITORING PROCEDURE NOT PERFORMED ("REPORTS IN PAST HAD ESSURE DONE, BUT NO FOLLOWING HYSTEROSALPINGOGRAM"). THE PATIENT HAD A MEDICAL HISTORY OF DYSURIA, PAPANICOLAOU SMEAR NORMAL, LIGAMENT PAIN, ALLERGY (ALLERGIES: NO KNOWN DRUG ALLERGIES FOOD ALLERGIES: KIWI, CANTALOPE, HONEYDEW MELON - ITCHY THROAT ALSO ALLERGIC TO HAND SANITIZER ¿ RASH), MIGRAINE HEADACHE, MUSCLE STRAIN AND OBESITY. R HROB DUE TO PREVIA AND DESIRES BILATERAL SALPINGECTOMY WHEN C/S DONE. EDC (B)(6) 2015, SO WILL SCHEDULE C/S WITH BILATERAL SALPINGECTOMY (B)(6) 2015 SHE OFFERS NO C/O, RARE BRAXTON HICKS CONTRACTION, REPORTS (+)FM. REPORTS IN PAST HAD ESSURE DONE, BUT NO FOLLOWING HYSTEROSALPINGOGRAM THEN GOT PREGNANT. DEFINITELY DESIRES NO FUTURE FERTILITY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: CALCIUM, PNV, FISH OIL, PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS] AND MIRENA. THE PATIENT HAD A FAMILY HISTORY OF TWIN PREGNANCY (TWIN WITH AUTISM), HEPATITIS AND TYPE 2 DIABETES MELLITUS. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, 369 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED PREGNANCY WITH CONTRACEPTIVE DEVICE ("PREGNANCY WITH CONTRACEPTIVE DEVICE"). ON (B)(6) 2015 SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED ON (B)(6) 2015. THE PATIENT WAS TREATED WITH SURGERY (1. MINILAPAROTOMY . 2. BILATERAL FIMBRIECTOMY.). AT THE TIME OF THE REPORT, THE OUTCOMES FOR MEDICAL DEVICE REMOVAL AND PREGNANCY WITH CONTRACEPTIVE DEVICE WERE UNKNOWN. PREGNANCY RELATED INFORMATION: RETROSPECTIVE REPORT. LAST MENSTRUAL PERIOD WAS ON (B)(6) 2014 AND THE ESTIMATED DATE OF DELIVERY WAS ON (B)(6) 2014. THE PREGNANCY OUTCOME WAS REPORTED AS A LIVE BIRTH OF A HEALTHY CHILD. THE DELIVERY OCCURRED ON AN UNKNOWN DATE. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL AND PREGNANCY WITH CONTRACEPTIVE DEVICE TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX: 31.221 KG/SQM. [PATHOLOGY TEST] ON (B)(6) 2015: SURGICAL PATHOLOGY REPORT: SPECIMENS SUBMITTED: A. RIGHT FALLOPIAN TUBE. B. LEFT FALLOPIAN TUBE. DIAGNOSIS: A. RIGHT FALLOPIAN TUBE; STERILIZATION: COMPLETE CROSS-SECTION OF BENIGN FALLOPIAN TUBE B. LEFT FALLOPIAN TUBE; STERILIZATION: COMPLETE CROSS-SECTION OF BENIGN FALLOPIAN TUBECLINICAL INFORMATION: BILATERAL SALPINGECTOMY, DESIRES PERMANENT STERILIZATION. GROSS DESCRIPTION: RIGHT FALLOPIAN TUBE: FIMBRIATED FALLOPIAN TUBE WITH AN ATTACHED 1.0 CM SESSILE PARATUBAL CYST LEFT FALLOPIAN TUBE: FIMBRIATED FALLOPIAN TUBE WITH A 1.0 CM ATTACHED SESSILE PARATUBAL CYST. [ULTRASOUND SCAN] ON (B)(6) 2015: TRANSABDOMINAL OBSTETRIC FETAL ULTRASOUND RESULTS:THERE IS A SINGLE LIVE INTRAUTERINE PREGNANCY IN CEPHALIC PRESENTATION. M-MODE IMAGING REVEALED A HEART RATE OF 150 BEATS PER MINUTE. ,REF306-INVALID LOT LOT NUMBER: C06468 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: 30-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 29 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2015, 973 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 (SURGICAL REMOVAL OF COILS). 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 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 |
|---|---|---|---|---|---|---|---|
| 1185589 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | C06468 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Female | Required Intervention |