ESSURE
Report
- Report Number
- 2951250-2020-15337
- Event Type
- Injury
- Date Received
- October 26, 2020
- Report Date
- October 28, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 787228,(862530-INV)) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HYDATID CYST, RIGHT LOWER QUADRANT PAIN, PARATUBAL CYST AND PELVIC PAIN FEMALE. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEVICE EXPULSION ("THE COIL ON THE RIGHT REMAINED ALMOST COMPLETELY WITHIN UTERINE CAVITY & ON LEFT ONLY A SMALL AMOUNT OF COIL REMAINING IN THE UTERINE CAVITY"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL LAPAROSCOPIC SALPINGECTOMY,REMOVAL OF UTERINE HARDWARE). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND DEVICE EXPULSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE EXPULSION AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: WITHIN THE LEFT FALLOPIAN TUBE, THERE IS A COILED GRAY METAL WIRE 2.5 CM IN LENGTH BY LESS THAN 0.1 CM IN DIAMETER. REMOVAL PROCEDURE: THE COIL ON THE RIGHT REMAINED ALMOST COMPLETELY WITHIN THE UTERINE CAVITY. A GRASPER WAS USED TO EXTRACT THAT. A SMALL AMOUNT OF BLEEDING WAS ENCOUNTERED WHICH WAS CONTROLLED USING THE ELECTRO SURGICAL DEVICE ON THE FIELD. ON THE LEFT THE SAME WAS REPEATED THIS FAR AS REMOVING THE FALLOPIAN TUBE. ONCE I GOT TO THE LEVEL OF THE UTERUS THE TUBE WAS TRANSECTED AND THERE WAS ONLY A SMALL AMOUNT OF COIL REMAINING IN THE UTERINE CAVITY WHICH WAS GRASPED WITH THE GRASPERS. AGAIN ELECTROCAUTERY WAS USED TO CONTROL THE BLEEDING AT THIS SITE. THE TUBES WERE THEN REMOVED FROM THE SURGICAL FIELD THROUGH THE 5 MM TROCARS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: THERE IS GREAT OPACIFICATION, AND THERE IS BILATERAL PROXIMAL TUBAL OCCLUSION BY THE ESSURE DEVICE.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: 'CHRONIC PELVIC PAIN AND DEVICE EXPULSION ". LOT NUMBER REPORTED (862530) IS NOT VALID. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-OCT-2020: UPDATE OF INFORMATION (BATCH IS NOT VALID). 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 REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 787228,(862530-INV)) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HYDATID CYST, RIGHT LOWER QUADRANT PAIN, PARATUBAL CYST AND PELVIC PAIN FEMALE. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEVICE EXPULSION ("THE COIL ON THE RIGHT REMAINED ALMOST COMPLETELY WITHIN UTERINE CAVITY & ON LEFT ONLY A SMALL AMOUNT OF COIL REMAINING IN THE UTERINE CAVITY"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL LAPAROSCOPIC SALPINGECTOMY,REMOVAL OF UTERINE HARDWARE). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND DEVICE EXPULSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE EXPULSION AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: WITHIN THE LEFT FALLOPIAN TUBE, THERE IS A COILED GRAY METAL WIRE 2.5 CM IN LENGTH BY LESS THAN 0.1 CM IN DIAMETER. REMOVAL PROCEDURE: THE COIL ON THE RIGHT REMAINED ALMOST COMPLETELY WITHIN THE UTERINE CAVITY. A GRASPER WAS USED TO EXTRACT THAT. A SMALL AMOUNT OF BLEEDING WAS ENCOUNTERED WHICH WAS CONTROLLED USING THE ELECTRO SURGICAL DEVICE ON THE FIELD. ON THE LEFT THE SAME WAS REPEATED THIS FAR AS REMOVING THE FALLOPIAN TUBE. ONCE I GOT TO THE LEVEL OF THE UTERUS THE TUBE WAS TRANSECTED AND THERE WAS ONLY A SMALL AMOUNT OF COIL REMAINING IN THE UTERINE CAVITY WHICH WAS GRASPED WITH THE GRASPERS. AGAIN ELECTROCAUTERY WAS USED TO CONTROL THE BLEEDING AT THIS SITE. THE TUBES WERE THEN REMOVED FROM THE SURGICAL FIELD THROUGH THE 5 MM TROCARS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: THERE IS GREAT OPACIFICATION, AND THERE IS BILATERAL PROXIMAL TUBAL OCCLUSION BY THE ESSURE DEVICE.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: 'CHRONIC PELVIC PAIN AND DEVICE EXPULSION ". LOT NUMBER REPORTED (862530) IS NOT VALID. LOT NUMBER: 787228 MANUFACTURING DATE: 2010-10 EXPIRATION DATE: 2013-10. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 28-OCT-2020: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). 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 REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('CHRONIC PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 787228, 862530) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HYDATID CYST, RIGHT LOWER QUADRANT PAIN, PARATUBAL CYST AND PELVIC PAIN FEMALE. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND DEVICE EXPULSION ("THE COIL ON THE RIGHT REMAINED ALMOST COMPLETELY WITHIN UTERINE CAVITY & ON LEFT ONLY A SMALL AMOUNT OF COIL REMAINING IN THE UTERINE CAVITY"). THE PATIENT WAS TREATED WITH SURGERY (BILATERAL LAPAROSCOPIC SALPINGECTOMY,REMOVAL OF UTERINE HARDWARE). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND DEVICE EXPULSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE EXPULSION AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: WITHIN THE LEFT FALLOPIAN TUBE, THERE IS A COILED GRAY METAL WIRE 2.5 CM IN LENGTH BY LESS THAN 0.1 CM IN DIAMETER. REMOVAL PROCEDURE: THE COIL ON THE RIGHT REMAINED ALMOST COMPLETELY WITHIN THE UTERINE CAVITY. A GRASPER WAS USED TO EXTRACT THAT. A SMALL AMOUNT OF BLEEDING WAS ENCOUNTERED WHICH WAS CONTROLLED USING THE ELECTRO SURGICAL DEVICE ON THE FIELD. ON THE LEFT THE SAME WAS REPEATED THIS FAR AS REMOVING THE FALLOPIAN TUBE. ONCE I GOT TO THE LEVEL OF THE UTERUS THE TUBE WAS TRANSECTED AND THERE WAS ONLY A SMALL AMOUNT OF COIL REMAINING IN THE UTERINE CAVITY WHICH WAS GRASPED WITH THE GRASPERS. AGAIN ELECTROCAUTERY WAS USED TO CONTROL THE BLEEDING AT THIS SITE. THE TUBES WERE THEN REMOVED FROM THE SURGICAL FIELD THROUGH THE 5 MM TROCARS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: THERE IS GREAT OPACIFICATION, AND THERE IS BILATERAL PROXIMAL TUBAL OCCLUSION BY THE ESSURE DEVICE.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: 'CHRONIC PELVIC PAIN AND DEVICE EXPULSION ". 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1197643 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 787228,(862530-INV) | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |