ESSURE
Report
- Report Number
- 2951250-2024-00700
- Event Type
- Injury
- Date Received
- November 14, 2024
- Report Date
- November 18, 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
BAYER CASE NUMBER: (B)(4). TUBAL OCCLUSION DEVICE PERFORATION WITH PERITONEAL POSITION¿S (A) SHOWS FAR LATERAL AND SUPERIOR POSITION OF THE RIGHT INSERT (ARROW) WITH RESPECT TO THE RIGHT UTERINE CORNUA [UTERINE PERFORATION] CASE NARRATIVE: THIS CASE INFORMATION FROM A PUBLISHED STUDY WAS REPORTED BY A HEALTHCARE PROFESSIONAL AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("TUBAL OCCLUSION DEVICE PERFORATION WITH PERITONEAL POSITION¿S (A) SHOWS FAR LATERAL AND SUPERIOR POSITION OF THE RIGHT INSERT (ARROW) WITH RESPECT TO THE RIGHT UTERINE CORNUA") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. LITERATURE REFERENCE: LEE M.; MELAMUD K.; PETROCELLI R.; SLYWOTZKY C.; PRABHU V.. COMPREHENSIVE MULTIMODALITY IMAGING REVIEW OF REPRODUCTIVE INTERVENTIONS AND THEIR COMPLICATIONS. CLINICAL IMAGING. 2024; 116: ARTICLE NUMBER: 110312. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE SHE EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). IT WAS UNKNOWN WHETHER ANY ACTION WAS TAKEN WITH ESSURE. AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED UTERINE PERFORATION TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: CASE NO-3 FOR ONE-WOMAN TUBAL OCCLUSION DEVICE PERFORATION WITH PERITONEAL POSITION¿S (A) SHOWS FAR LATERAL AND SUPERIOR POSITION OF THE RIGHT INSERT (ARROW) WITH RESPECT TO THE RIGHT UTERINE CORNUA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [COMPUTERISED TOMOGRAM] (DATE UNKNOWN): S THE MIGRATED RIGHT INSERT (ARROW) UNDERLYING THE RIGHT ANTERIOR PELVIC WALL. THERE WAS NO BOWEL OBSTRUCTION OR PERFORATION. [HYSTEROSALPINGOGRAM] (DATE UNKNOWN): SHOWS FAR LATERAL AND SUPERIOR POSITION OF THE RIGHT INSERT (ARROW) WITH RESPECT TO THE RIGHT UTERINE CORNUA. THERE IS NO CONTRAST SPILLAGE BEYOND THE UTEROTUBAL JUNCTIONS (ARROWHEADS). SUPINE RADIOGRAPH (B) AGAIN SHOWS THE RIGHT INSERT (ARROW) OVERLYING THE RIGHT ILIAC WING. 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. LITERATURE ABSTRACT THE INCREASING PREVALENCE OF PELVIC DEVICES AND REPRODUCTIVE INTERVENTIONS HAS PLACED GROWING DEMANDS ON RADIOLOGISTS FOR PROPER IDENTIFICATION, DESCRIPTION, AND DIAGNOSIS OF COMPLICATIONS. FOR EXAMPLE, FROM 2002 TO 2014, INTRAUTERINE DEVICE (IUD) USE AMONGST WOMEN USING CONTRACEPTION IN THE U.S. INCREASED FROM 2 % TO 14 %.1,2 MANY REPRODUCTIVE INTERVENTIONS REQUIRE SPECIFIC KNOWLEDGE OF THEIR NORMAL MULTIMODALITY APPEARANCE, AND COMPLICATIONS MAY BE SUBTLE DEPENDING ON THE MODALITY USED. FURTHERMORE, OBSOLETE DEVICES REMAIN IMPORTANT DESPITE THEIR INFREQUENT USE, AS PATIENTS MAY RETAIN THEM AND FACE LONGTERM RISKS. THEREFORE, RADIOLOGISTS MUST RECOGNIZE BOTH NORMAL AND ABNORMAL APPEARANCES OF VARIOUS PELVIC DEVICES. THE FOLLOWING REPRODUCTIVE INTERVENTIONS WILL BE DISCUSSED IN THIS COMPREHENSIVE REVIEW: IUDS, TUBAL OCCLUSION DEVICES, TUBAL STERILIZATION, CONTRACEPTIVE RINGS, AND SUBDERMAL CONTRACEPTIVE IMPLANTS. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 15-NOV-2024: QUALITY SAFETY EVALUATION OF PTC. CASE COMMENTS: 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.
BAYER CASE NUMBER: (B)(4). TUBAL OCCLUSION DEVICE PERFORATION WITH PERITONEAL POSITION¿S (A) SHOWS FAR LATERAL AND SUPERIOR POSITION OF THE RIGHT INSERT (ARROW) WITH RESPECT TO THE RIGHT UTERINE CORNUA [UTERINE PERFORATION]. CASE NARRATIVE: THIS CASE INFORMATION FROM A PUBLISHED STUDY WAS REPORTED BY A HEALTHCARE PROFESSIONAL AND DESCRIBES THE OCCURRENCE OF UTERINE PERFORATION ("FOR ONE-WOMAN TUBAL OCCLUSION DEVICE PERFORATION WITH PERITONEAL POSITION¿S (A) SHOWS FAR LATERAL AND SUPERIOR POSITION OF THE RIGHT INSERT (ARROW) WITH RESPECT TO THE RIGHT UTERINE CORNUA") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. LITERATURE REFERENCE: LEE M.; MELAMUD K.; PETROCELLI R.; SLYWOTZKY C.; PRABHU V.. COMPREHENSIVE MULTIMODALITY IMAGING REVIEW OF REPRODUCTIVE INTERVENTIONS AND THEIR COMPLICATIONS. CLINICAL IMAGING. 2024; 116: ARTICLE NUMBER: 110312. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE SHE EXPERIENCED UTERINE PERFORATION (SERIOUSNESS CRITERION MEDICALLY IMPORTANT). IT WAS UNKNOWN WHETHER ANY ACTION WAS TAKEN WITH ESSURE. AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED UTERINE PERFORATION TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: CASE NO-3 FOR ONE-WOMAN TUBAL OCCLUSION DEVICE PERFORATION WITH PERITONEAL POSITION¿S (A) SHOWS FAR LATERAL AND SUPERIOR POSITION OF THE RIGHT INSERT (ARROW) WITH RESPECT TO THE RIGHT UTERINE CORNUA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [COMPUTERISED TOMOGRAM] (DATE UNKNOWN): S THE MIGRATED RIGHT INSERT (ARROW) UNDERLYING THE RIGHT ANTERIOR PELVIC WALL. THERE WAS NO BOWEL OBSTRUCTION OR PERFORATION. [HYSTEROSALPINGOGRAM] (DATE UNKNOWN): SHOWS FAR LATERAL AND SUPERIOR POSITION OF THE RIGHT INSERT (ARROW) WITH RESPECT TO THE RIGHT UTERINE CORNUA. THERE IS NO CONTRAST SPILLAGE BEYOND THE UTEROTUBAL JUNCTIONS (ARROWHEADS). SUPINE RADIOGRAPH (B) AGAIN SHOWS THE RIGHT INSERT (ARROW) OVERLYING THE RIGHT ILIAC WING. 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 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. LITERATURE ABSTRACT: THE INCREASING PREVALENCE OF PELVIC DEVICES AND REPRODUCTIVE INTERVENTIONS HAS PLACED GROWING DEMANDS ON RADIOLOGISTS FOR PROPER IDENTIFICATION, DESCRIPTION, AND DIAGNOSIS OF COMPLICATIONS. FOR EXAMPLE, FROM 2002 TO 2014, INTRAUTERINE DEVICE (IUD) USE AMONGST WOMEN USING CONTRACEPTION IN THE U.S. INCREASED FROM 2 % TO 14 %.1,2 MANY REPRODUCTIVE INTERVENTIONS REQUIRE SPECIFIC KNOWLEDGE OF THEIR NORMAL MULTIMODALITY APPEARANCE, AND COMPLICATIONS MAY BE SUBTLE DEPENDING ON THE MODALITY USED. FURTHERMORE, OBSOLETE DEVICES REMAIN IMPORTANT DESPITE THEIR INFREQUENT USE, AS PATIENTS MAY RETAIN THEM AND FACE LONGTERM RISKS. THEREFORE, RADIOLOGISTS MUST RECOGNIZE BOTH NORMAL AND ABNORMAL APPEARANCES OF VARIOUS PELVIC DEVICES. THE FOLLOWING REPRODUCTIVE INTERVENTIONS WILL BE DISCUSSED IN THIS COMPREHENSIVE REVIEW: IUDS, TUBAL OCCLUSION DEVICES, TUBAL STERILIZATION, CONTRACEPTIVE RINGS, AND SUBDERMAL CONTRACEPTIVE IMPLANTS. CASE COMMENTS: 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 |
|---|---|---|---|---|---|---|---|
| 1169665 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |