ESSURE
Report
- Report Number
- 2951250-2023-02192
- Event Type
- Injury
- Date Received
- May 22, 2023
- Date of Event
- January 1, 2021
- Report Date
- December 1, 2023
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- 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 UTERINE PERFORATION ("ESHER COIL IN THE LEFT HAS PERFORATED AT THE CORNUA INTO THE UTERINE SEROSA") AND DEVICE BREAKAGE ("THE FRAGMENTS WERE HANDED OFF THE TABLE") IN A 36 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: COMPLICATION OF DEVICE REMOVAL ("COMPLICATION OF DEVICE REMOVAL"). THE PATIENT HAD A MEDICAL HISTORY OF UTERINE FIBROID, MALAISE, FATIGUE, ENDOMETRIOSIS, LIVE BIRTH, MULTIPAROUS, EYE OPERATION, ADENOMYOSIS, JOINT ACHE, MUSCLE ACHE, ABNORMAL UTERINE BLEEDING, PAIN AND CRAMP IN 2021, OVERWEIGHT IN 2016 AND C-SECTION AND PARITY 3 (PREGNANCY 1: (B)(6) 2005-40 WEEKS -FEMALE-C-SECTION- FAILURE TO DIALATE. PREGNANCY 2: (B)(6) 2010-40 WEEKS-FEMALE-VBAC. PREGNANCY 3: (B)(6) 2016-40 WEEKS-MALE-NSVD) IN 2005. CONCURRENT CONDITIONS WERE LISTED AS DYSFUNCTIONAL UTERINE BLEEDING AND PELVIC PAIN. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ESSURE WAS REMOVED ON (B)(6) 2022. AN UNKNOWN TIME LATER SHE EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED) AND DEVICE BREAKAGE (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (SURGICAL REMOVAL OF COILS, LAPAROSCOPY, BILATERAL SALPINGOSTOMY, REMOVAL OF ESSURE BILATERALLY AND BILATERAL SALPINGOSTOMY). AT THE TIME OF THE REPORT, THE OUTCOMES FOR UTERINE PERFORATION AND DEVICE BREAKAGE WERE UNKNOWN. THE REPORTER CONSIDERED DEVICE BREAKAGE AND UTERINE PERFORATION TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: RIGHT FALLOPIAN TUBE- 0 TRAILING COILS. LEFT FALLOPIEAN TUBE- 2 TRAILING COILS. DATE DISCREPANCY NOTED IN EXPLANTED DATE: (B)(6) 2021 INSTEAD OF (B)(6) 2022. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX: 29.625 KG/SQM. [PATHOLOGY TEST] ON (B)(6) 2022: SURGICAL PATHOLOGY REPORT: DIAGNOSIS: A. FOREIGN BODY,RIGHT ESSURE COIL:ESSURE COIL. B. FOREIGN BODY,LEFT ESSURE COIL:ESSURE COIL. CLINICAL INFORMATION: RETAINED ESSURE COILS. SOURCE: FOREIGN BODY,RIGHT ESSURE COIL. FOREIGN BODY,LEFT ESSURE COIL. GROSS DESCRIPTION: A. ONLY TWO TIGHTLY COILED METALLIC WIRES,3.5 CM AND 4.5 CM IN GREATEST DIMENSION. THESE ARE CONSISTENT WITH ESSURE COILS. B. ONLY TWO TIGHTLY COILED METALLIC WIRES,5.5 CM IN GREATEST DIMENSION. [ULTRASOUND SCAN] ON (B)(6) 2021: ESSURE COILS BILATERALLY. 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: 25-OCT-2023: MEDICAL RECORD RECEIVED. EVENT MEDICAL DEVICE REMOVAL IS REPLACED WITH EVENT UTERINE PERFORATION . NEW EVENTS DEVICE BREAKAGE & COMPLICATION OF DEVICE REMOVAL ADDED REPORTER, MEDICAL HISTORY, LAB DATA, PRODUCT INDICATION, REPORTER CAUSALITY COMMENT ADDED. NON-DRUG TREATMENT NOTES WAS UPDATED. 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 36 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2021, 1827 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 THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 10-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 UTERINE PERFORATION ("ESHER COIL IN THE LEFT HAS PERFORATED AT THE CORNUA INTO THE UTERINE SEROSA") IN A 36 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: COMPLICATION OF DEVICE REMOVAL ("COMPLICATION OF DEVICE REMOVAL"). THE PATIENT HAD A MEDICAL HISTORY OF UTERINE FIBROID, MALAISE, FATIGUE, ENDOMETRIOSIS, LIVE BIRTH, MULTIPAROUS, EYE OPERATION, ADENOMYOSIS, JOINT ACHE, MUSCLE ACHE, ABNORMAL UTERINE BLEEDING, PAIN AND CRAMP IN 2021, OVERWEIGHT IN 2016 AND C-SECTION AND PARITY 3 (PREGNANCY 1: (B)(6) 2005 40 WEEKS FEMALE-C-SECTION- FAILURE TO DIALATE. PREGNANCY 2: (B)(6) 2010 40 WEEKS FEMALE-VBAC. PREGNANCY 3: (B)(6) 2016 40 WEEKS MALE-NSVD). IN 2005. CONCURRENT CONDITIONS WERE LISTED AS DYSFUNCTIONAL UTERINE BLEEDING AND PELVIC PAIN. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ESSURE WAS REMOVED ON (B)(6) 2022. AN UNKNOWN TIME LATER SHE EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (SURGICAL REMOVAL OF COILS, LAPAROSCOPY, BILATERAL SALPINGOSTOMY, REMOVAL OF ESSURE BILATERALLY). AT THE TIME OF THE REPORT, THE OUTCOME OF UTERINE PERFORATION WAS UNKNOWN. THE REPORTER CONSIDERED UTERINE PERFORATION TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: RIGHT FALLOPIAN TUBE- 0 TRAILING COILS. LEFT FALLOPIEAN TUBE- 2 TRAILING COILS. DATE DISCREPANCY NOTED IN EXPLANTED DATE: (B)(6) 2021 INSTEAD OF (B)(6) 2022. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX: 29.625 KG/SQM. [PATHOLOGY TEST] ON (B)(6) 2022: SURGICAL PATHOLOGY REPORT: DIAGNOSIS: A. FOREIGN BODY,RIGHT ESSURE COIL:ESSURE COIL. B. FOREIGN BODY,LEFT ESSURE COIL:ESSURE COIL. CLINICAL INFORMATION: RETAINED ESSURE COILS. SOURCE: FOREIGN BODY,RIGHT ESSURE COIL. FOREIGN BODY,LEFT ESSURE COIL. GROSS DESCRIPTION: A. ONLY TWO TIGHTLY COILED METALLIC WIRES,3.5 CM AND 4.5 CM IN GREATEST DIMENSION. THESE ARE CONSISTENT WITH ESSURE COILS. B. ONLY TWO TIGHTLY COILED METALLIC WIRES,5.5 CM IN GREATEST DIMENSION. [ULTRASOUND SCAN] ON (B)(6) 2021: ESSURE COILS BILATERALLY. 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: 29-NOV-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 36 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2021, 1827 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 |
|---|---|---|---|---|---|---|---|
| 780458 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Female | Required Intervention |