ESSURE
Report
- Report Number
- 2951250-2020-08038
- Event Type
- Injury
- Date Received
- May 21, 2020
- Report Date
- May 18, 2021
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('DEVICE BREAKAGE/PART OF IT BROKE IN HALF /SEVERAL COILED PIECES OF SILVER METALLIC WIRE.') AND DEVICE EXPULSION ('MIGRATION/ LEFT ESSURE COIL WAS MORE PROXIMAL IN THE TUBE WITH A MORE SIGNIFICANT PORTION (APPROXIMATELY ONE-THIRD) OF THAT COIL IN THE UTERINE CAVITY') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 841857 , 872990) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE PHYSICAL PROPERTY ISSUE "LEFT ESSURE COIL HAD CURLED UP". THE PATIENT'S MEDICAL HISTORY INCLUDED LEFT LOWER QUADRANT PAIN, PELVIC PAIN, GRAVIDA I, PARITY 1, DYSPAREUNIA, CESAREAN SECTION, DEPRESSION, DRUG ALLERGY, MENORRHAGIA, PELVIC ADHESIONS AND ABNORMAL UTERINE BLEEDING. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IBUPROFEN, SPIRONOLACTONE, MIRENA, HYDROXYZINE AND LOPRESSOR. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN"), GENITAL HAEMORRHAGE ("GENITAL ABNORMAL BLEEDING"), POST PROCEDURAL COMPLICATION ("POST PROCEDURAL COMPLICATION") AND PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"). THE PATIENT WAS TREATED WITH SURGERY (DA VINCI ROBOTIC ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE EXPULSION, PELVIC PAIN, GENITAL HAEMORRHAGE, POST PROCEDURAL COMPLICATION AND PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE BREAKAGE, DEVICE EXPULSION, GENITAL HAEMORRHAGE, PELVIC PAIN, POST PROCEDURAL COMPLICATION AND PSYCHOLOGICAL TRAUMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TREATMENT GIVEN FOR PAIN, BLEEDING AND MIGRATION OF DEVICE. DISCREPANCY NOTED IN DATE OF INSERTION: (B)(6) 2011(AS PER MR). RIGHT FALLOPIAN TUBE: APPROXIMATELY 2 COILS WERE SEEN ON THE RIGHT TUBE AFTER PLACEMENT. LEFT FALLOPIAN TUBE: APPROXIMATELY 6 TO 8 SUCH COILS WERE SEEN ON THAT SIDE. (B)(6) 2012: OPERATIONS 1. OPERATIVE HYSTEROSCOPY WITH REMOVAL OF LEFT ESSURE COIL. 2. OPERATIVE LAPAROSCOPY WITH LAPAROSCOPIC LYSIS OF PELVIC ADHESIONS (B)(6) 2015: OPERATION: DA VINCI ROBOTIC ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: BILATERAL TUBAL OCCLUSION.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING WERE REPORTED FROM PATIENT¿S MEDICAL RECORD: DEVICE EXPULSION, DEVICE BREAKAGE. LOT NUMBER:841857 MANUFACTURE DATE:2011-03 EXPIRATION DATE: 2014-03 LOT NUMBER: 872990 MANUFACTURE DATE:2011-06 EXPIRATION DATE: 2014-06 QUALITY-SAFETY EVALUATION OF PTC: 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-MAY-2021: 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 REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('DEVICE BREAKAGE/PART OF IT BROKE IN HALF /SEVERAL COILED PIECES OF SILVER METALLIC WIRE.') AND DEVICE EXPULSION ('MIGRATION/ LEFT ESSURE COIL WAS MORE PROXIMAL IN THE TUBE WITH A MORE SIGNIFICANT PORTION (APPROXIMATELY ONE-THIRD) OF THAT COIL IN THE UTERINE CAVITY') IN A 27-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. R-872990, L-841857) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE PHYSICAL PROPERTY ISSUE "LEFT ESSURE COIL HAD CURLED UP". THE PATIENT'S MEDICAL HISTORY INCLUDED LEFT LOWER QUADRANT PAIN, PELVIC PAIN, GRAVIDA I, PARITY 1, DYSPAREUNIA, CESAREAN SECTION, DEPRESSION, DRUG ALLERGY, MENORRHAGIA, PELVIC ADHESIONS AND ABNORMAL UTERINE BLEEDING. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: IBUPROFEN, SPIRONOLACTONE, MIRENA, HYDROXYZINE AND LOPRESSOR. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE EXPULSION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN"), GENITAL HAEMORRHAGE ("GENITAL ABNORMAL BLEEDING"), POST PROCEDURAL COMPLICATION ("POST PROCEDURAL COMPLICATION") AND PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"). THE PATIENT WAS TREATED WITH SURGERY (DA VINCI ROBOTIC ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2015. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, DEVICE EXPULSION, PELVIC PAIN, GENITAL HAEMORRHAGE, POST PROCEDURAL COMPLICATION AND PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE BREAKAGE, DEVICE EXPULSION, GENITAL HAEMORRHAGE, PELVIC PAIN, POST PROCEDURAL COMPLICATION AND PSYCHOLOGICAL TRAUMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TREATMENT GIVEN FOR PAIN, BLEEDING AND MIGRATION OF DEVICE. DISCREPANCY NOTED IN DATE OF INSERTION: (B)(6) 2011(AS PER MR). RIGHT FALLOPIAN TUBE: APPROXIMATELY 2 COILS WERE SEEN ON THE RIGHT TUBE AFTER PLACEMENT. LEFT FALLOPIAN TUBE: APPROXIMATELY 6 TO 8 SUCH COILS WERE SEEN ON THAT SIDE. (B)(6) 2012: OPERATIONS 1. OPERATIVE HYSTEROSCOPY WITH REMOVAL OF LEFT ESSURE COIL. 2. OPERATIVE LAPAROSCOPY WITH LAPAROSCOPIC LYSIS OF PELVIC ADHESIONS (B)(6) 2015: OPERATION: DA VINCI ROBOTIC ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGECTOMY . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: BILATERAL TUBAL OCCLUSION.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING WERE REPORTED FROM PATIENT¿S MEDICAL RECORD: DEVICE EXPULSION, DEVICE BREAKAGE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 26-APR-2021: MEDICAL RECORD RECEIVED: LOT NUMBER, MEDICAL HISTORY, LAB DATA, REMOVAL DATE, PATIENT DEMOGRAPHIC, REPORTER INFORMATION ADDED. EVENT DEVICE DISLOCATION UPDATED TO DEVICE EXPULSION. EVENT MEDICAL DEVICE REMOVAL UPDATED TO NEW EVENT DEVICE SHAPE ALTERATION. 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 REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('DEVICE BREAKAGE') AND MEDICAL DEVICE REMOVAL ('MEDICAL DEVICE REMOVAL') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC PAIN"), GENITAL HAEMORRHAGE ("GENITAL ABNORMAL BLEEDING"), DEVICE DISLOCATION ("MIGRATION"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY") AND POST PROCEDURAL COMPLICATION ("POST PROCEDURAL COMPLICATION") AND UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (SURGICAL REMOVAL OF COILS). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, MEDICAL DEVICE REMOVAL, PELVIC PAIN, GENITAL HAEMORRHAGE, DEVICE DISLOCATION, PSYCHOLOGICAL TRAUMA AND POST PROCEDURAL COMPLICATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE BREAKAGE, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, MEDICAL DEVICE REMOVAL, PELVIC PAIN, POST PROCEDURAL COMPLICATION AND PSYCHOLOGICAL TRAUMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TREATMENT GIVEN FOR PAIN, BLEEDING AND MIGRATION OF DEVICE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-MAY-2020: PFS RECEIVED : PREVIOUSLY REPORTED EVENT ¿INJURY¿ WAS DELETED. THE EVENTS ¿DEVICE BREAKAGE¿, ¿MEDICAL DEVICE REMOVAL¿, ¿PELVIC PAIN¿, ¿GENITAL ABNORMAL BLEEDING¿, ¿MIGRATION¿, ¿PSYCH INJURY¿ AND ¿POST PROCEDURAL COMPLICATION¿ WERE ADDED. PATIENT DATE OF BIRTH WAS ADDED. REPORTER INFORMATION WAS ADDED. CASE CATEGORY CHANGED TO VALID. ON 9-JAN-2020: PFS RECEIVED. PRODUCT INDICATION UPDATED. 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 |
|---|---|---|---|---|---|---|---|
| 544881 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 841857 , 872990 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Other| R |