FALLOPIAN TUBE OCCLUSION INSERT
Report
- Report Number
- 2951250-2025-00337
- Event Type
- Injury
- Date Received
- May 17, 2025
- Report Date
- May 21, 2025
- 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
BAYER CASE NUMBER: (B)(4). MICROINSERTION PERFORATION ADJACENT TO THE TRUE OSTIUM [PERFORATION OF UTERUS]. CASE NARRATIVE: THIS CASE INFORMATION FROM A PUBLISHED STUDY WAS REPORTED BY AN INVESTIGATOR AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("MICROINSERTION PERFORATION ADJACENT TO THE TRUE OSTIUM") IN A FEMALE PATIENT WHO HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED FOR FEMALE STERILISATION. LITERATURE REFERENCE: JOHN F. KERIN, JAY M. COOPER, THOMAS PRICE, BRUNO J.VAN HERENDAEL ENRIQUE CAYUELA-FONT, DANIEL CHER AND CHARLES S. CARIGNAN. HYSTEROSCOPIC STERILIZATION USING A MICRO-INSERT DEVICE: RESULTS OF A MULTICENTRE PHASE IL STUDY. EUROPEAN SOCIETY OF HUMAN REPRODUCTION AND EMBRYOLOGY. 2003; 18: 1223-1230. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON AN UNKNOWN DATE, THE PATIENT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ON AN UNKNOWN DATE SHE EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). FALLOPIAN TUBE OCCLUSION INSERT WAS REMOVED. THE REPORTER CONSIDERED UTERINE PERFORATION TO BE RELATED TO FALLOPIAN TUBE OCCLUSION INSERT ADMINISTRATION. QUALITY-SAFETY EVALUATION OF PTC: FOR FALLOPIAN TUBE OCCLUSION INSERT: 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 ANALYSIS 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-MAY-2025: NO NEW INFORMATION RECEIVED. LITERATURE ARTICLE RE-ATTACHED TO THE REPORT. CASE COMMENTS: A FEMALE PATIENT EXPERIENCED UTERINE PERFORATION ('MICROINSERTION PERFORATION ADJACENT TO THE TRUE OSTIUM'), DIAGNOSED AFTER INSERTION ATTEMPT OF A ESSURE FOR CONTRACEPTION UTERINE PERFORATION ('MICROINSERTION PERFORATION ADJACENT TO THE TRUE OSTIUM') IS LISTED IN THE REFERENCE SAFETY INFORMATION (VERSION 03) OF ESSURE (FALLOPIAN TUBE OCCLUSION INSERT). CONSIDERING THE LOCALIZATION AND THE NATURE OF THE EVENT, FURTHERMORE THE SAFETY PROFILE OF ESSURE, THE CAUSALITY IS ASSESSED AS RELATED BY THE COMPANY. FURTHER INFORMATION HAS BEEN REQUESTED. 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. IN CASE A SAMPLE IS RECEIVED THE INVESTIGATION MIGHT LEAD TO DESTRUCTION OF THE SAMPLE IF REQUIRED TO PERFORM A PROPER ANALYSIS.
BAYER CASE NUMBER: (B)(4). MICROINSERT PERFORATION ADJACENT TO THE TRUE OSTIUM [PERFORATION OF UTERUS]. CASE NARRATIVE: THIS CASE INFORMATION FROM A PUBLISHED STUDY WAS REPORTED BY AN INVESTIGATOR AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("MICROINSERT PERFORATION ADJACENT TO THE TRUE OSTIUM") IN A FEMALE PATIENT WHO HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED FOR FEMALE STERILISATION. LITERATURE REFERENCE: JOHN F.KERIN , JAY M. COOPER, THOMAS PRICE, BRUNO J.VAN HERENDAEL ENRIQUE CAYUELA-FONT, DANIEL CHER AND CHARLES S.CARIGNAN. HYSTEROSCOPIC STERILIZATION USING A MICRO-INSERT DEVICE: RESULTS OF A MULTICENTRE PHASE IL STUDY. EUROPEAN SOCIETY OF HUMAN REPRODUCTION AND EMBRYOLOGY. 2003; 18: 1223-1230. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON AN UNKNOWN DATE, THE PATIENT HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED. ON AN UNKNOWN DATE SHE EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). FALLOPIAN TUBE OCCLUSION INSERT WAS REMOVED. THE REPORTER CONSIDERED UTERINE PERFORATION TO BE RELATED TO FALLOPIAN TUBE OCCLUSION INSERT ADMINISTRATION. QUALITY-SAFETY EVALUATION OF PTC: FOR FALLOPIAN TUBE OCCLUSION INSERT: 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 ANALYSIS 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. CASE COMMENTS: UTERINE PERFORATION ('MICROINSERT PERFORATION ADJACENT TO THE TRUE OSTIUM') IS LISTED IN THE REFERENCE SAFETY INFORMATION (VERSION 03) OF ESSURE (FALLOPIAN TUBE OCCLUSION INSERT). CONSIDERING THE LOCALIZATION AND THE NATURE OF THE EVENT, FURTHERMORE THE SAFETY PROFILE OF ESSURE, THE CAUSALITY IS ASSESSED AS RELATED BY THE COMPANY. FURTHER INFORMATION HAS BEEN REQUESTED. 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. IN CASE A SAMPLE IS RECEIVED THE INVESTIGATION MIGHT LEAD TO DESTRUCTION OF THE SAMPLE IF REQUIRED TO PERFORM A PROPER ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2049446 | FALLOPIAN TUBE OCCLUSION INSERT | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |