ESSURE
Report
- Report Number
- 2951250-2014-00302
- Event Type
- Malfunction
- Date Received
- July 24, 2014
- Date of Event
- June 25, 2014
- Report Date
- January 19, 2017
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT, REFERS TO A FEMALE PT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND DURING THE PROCEDURE ON ONE SIDE, ESSURE SYSTEM (C26941) CAME OUT OF THE FALLOPIAN TUBE; THE PHYSICIAN THEN SAW THAT THIS ESSURE SYSTEM WAS BROKEN. THE PT EXPERIENCED PAIN AND BLEEDING WITH ESSURE SYSTEM (C26941). HE TRIED TO PLACE ON THE SECOND SIDE, ESSURE SYSTEM (B85139) AND IT TWISTED DURING THE PLACEMENT. FOLLOWING THESE 2 FAILURES, 2 ESSURE SYSTEMS WERE WELL PLACED. ALL THE ABOVE REPORTED EVENTS ARE NON-SERIOUS EXCEPT FOR THE BLEEDING, WHICH WAS CONSIDERED SERIOUS DUE TO MEDICAL IMPORTANCE. THE EVENT ESSURE SYSTEM WAS BROKEN REGARDED AS A DEVICE BREAKAGE, IS UNLISTED ON THE REFERENCE SAFETY INFORMATION FOR ESSURE AND WAS CONSIDERED A NEAR-INCIDENT, AS ALTHOUGH IT DID NOT LEAD TO DEATH OR SERIOUS HEALTH DETERIORATION THIS MIGHT HAVE OCCURRED UNDER LESS FORTUNATE CIRCUMSTANCES. THE REMAINING EVENTS ARE NON-INCIDENTS AND LISTED (APART FOR THE UNLISTED EVENT ESSURE TWISTED DURING PLACEMENT). DURING DIFFICULT INSERTIONS, SINGLE CASES HAS BEEN REPORTED OF ESSURE BREAKAGE. ALSO DURING OR FOLLOWING THE INSERTION PROCEDURE, PAIN AND BLEEDING MAY OCCUR. IN THIS PARTICULAR CASE, CONSIDERING THAT THE REPORTED EVENTS OCCURRED IN ASSOCIATION WITH ESSURE PLACEMENT PROCEDURE THEIR CAUSAL RELATION WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. A PRODUCT TECHNICAL ANALYSIS AND FOLLOW-UP INFORMATION WILL BE REQUESTED.
DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.
FOLLOW-UP RECEIVED ON 22-JUL-2014: INTRODUCTION OF BETTOCCHI HYSTEROSCOPY WITHOUT PARTICULAR INCIDENT. UTERINE CAVITY WAS VERY THICK WITH FLAPS WHICH PREVENT FROM HAVING A GOOD VISUALIZATION. CIRCULAR HEMORRHAGE WAS OBSERVED (PREVIOUSLY REPORTED BLEEDING WITH ESSURE SYSTEM (C26941) WAS DELETED AS EVENT BECAUSE HEMORRHAGE OCCURRED BEFORE ESSURE INSERTION AND THEREFORE CASE WAS DOWNGRADED TO NON SERIOUS). TUBAL OSTIA WERE VISUALIZED WITH DIFFICULTY WITH RAPID OSTIA SPASM. PLACEMENT OF ESSURE ON THE RIGHT SIDE BUT IT TWISTED. REMOVAL WITH PLIERS. ANOTHER ESSURE WAS PLACED ON THE RIGHT SIDE WITHOUT INCIDENT WITH 4 COILS VISIBLE. PLACEMENT OF ESSURE SYSTEM ON THE LEFT WITHOUT PARTICULAR INCIDENT, 3 COILS VISIBLE (PREVIOUSLY REPORTED ON ONE SIDE, ESSURE SYSTEM (C26941) CAME OUT OF THE FALLOPIAN TUBE AND ON ONE SIDE ESSURE SYSTEM (C26941) WAS BROKEN, FOLLOWING THESE 2 FAILURES, 2 ESSURE SYSTEMS WERE WELL PLACED WERE DELETED, THUS THIS CASE WAS DOWNGRADED TO NON INCIDENT). NO FURTHER INFORMATION WILL BE AVAILABLE. CASE CLOSED. PTC INVESTIGATION RESULT WAS RECEIVED ON 23-JUL-2014. THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: PTC LOCAL NUMBER AND PTC GLOBAL NUMBER. FINAL ASSESSMENT: WHEN A TERM LIKE "BROKEN" IS USED WHEN DESCRIBING A DEVICE EVENT, IT IS DIFFICULT TO DETERMINE THE TRUE NATURE OF THE EVENT FROM THE COMPLAINT DESCRIPTION ALONE. UNLESS ADDITIONAL DETAIL IS PROVIDED IN THE EVENT DESCRIPTION, IT IS DIFFICULT TO DETERMINE IF THE REPORTER IS DESCRIBING AN EVENT WHERE THE MICRO-INSERT ACTUALLY BROKE INTO INDIVIDUAL PIECES, IF THE MICRO-INSERT BENT OR STRETCHED INTO AN UNINTENDED SHAPE, AND HENCE WAS CONSIDERED BY THE REPORTER TO BE "BROKEN", OR IF A DIFFERENT PORTION OF THE DELIVERY CATHETER WAS BROKEN OFF INSIDE THE PATIENT. FAILURE MODE/MECHANISM: THE ESSURE INSERT IS MADE UP OF A FLEXIBLE OUTER COIL THAT IS DEPLOYED INTO THE FALLOPIAN TUBE. THE INSERT'S OUTER COILS EXPAND TO CONFORM TO THE FALLOPIAN TUBE, ACUTELY ANCHORING ITSELF UNTIL THE INSERT ELICITS TISSUE INGROWTH. AFTER THE FIRST ROLL BACK IS COMPLETED AND THE BUTTON IS PRESSED, USER ATTEMPTS TO REPOSITION THE DEVICE COULD LEAD TO DETACHMENT DIFFICULTY, PREMATURE DEPLOYMENT, OR IMPROPER DEVICE FUNCTION. IF THE OUTER COILS OF THE MICRO-INSERT PARTIALLY DEPLOY DURING USER ATTEMPTS TO REPOSITIONING THE DEVICE AND THE COIL CATHETER IS NOT FULLY RETRACTED, THE OUTER COILS OF THE MICRO-INSERT COULD BECOME ENTANGLED WITHIN THE DISTAL PORTION OF THE COIL CATHETER. IF THE OUTER COILS ARE PARTIALLY DEPLOYED, THE INSERT WILL BEGIN TO ANCHOR ITSELF TO THE FALLOPIAN TUBE. IF THE INNER COIL IS STILL AFFIXED TO THE DELIVERY WIRE BECAUSE ALL IFU STEPS HAVE NOT YET BEEN COMPLETED, SUBSEQUENT ATTEMPTS BY THE USER TO REMOVE THE CATHETER ASSEMBLY MAY LEAD TO EITHER A STRETCHING OF THE MICROINSERT, STRETCHING OF THE INNER CATHETER LARGE TIGHT PITCH COIL, OR BREAKAGE OF THE LARGE TIGHT PITCH COIL. IF THE PHYSICIAN ATTEMPTS TO REMOVE A DEPLOYED MICRO-INSERT THAT IS LOCATED WITHIN THE FALLOPIAN TUBE BY PULLING ON THE OUTER COIL OF THE MICRO-INSERT WITH A GRASPER, THIS ACTION COULD ALSO LEAD TO BREAKAGE OF THE OUTER COIL OF THE MICROINSERT. SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT, OUTER CATHETER, THE INNER CATHETER, AND ALL PARTS WITHIN THE HANDLE ASSEMBLY TO CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR AND INSPECT THE DEVICE TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. IN THIS CASE, WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT AT THIS TIME. CONCLUSIONS: THE REPORT DID NOT STATE A PATIENT INJURY OCCURRED. THE POSSIBILITY OF PIECES OF THE DELIVERY SYSTEM OR MICRO-INSERT BREAKING OFF DURING THE PROCEDURE IS AN ANTICIPATED EVENT. ACCORDING TO THE DFMEA, THE MAIN CONSEQUENCE IS A PHYSICIAN INCONVENIENCE BECAUSE THE PROCEDURE COULD NEED TO BE ABORTED OR RESCHEDULED. MEDICAL ASSESSMENT: THE MEDICAL EVENTS REPORTED ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. ADDITIONALLY, THIS CASE REPORTED COMPLICATION OF INSERTION DUE TO BREAKAGE OF ONE DEVICE AND A PHYSICAL PROPERTY ISSUS WITH THE OTHER DEVICE. ONE (1) ADDITIONAL AE CASE REPORT HAS BEEN RECEIVED TO DATE IN RELATION TO BATCH NUMBER B85139 BUT THIS CASE DOESN'T REFER TO ANY SIMILAR MEDICAL EVENTS OR BREAKAGE EVENT. NO ADDITIONAL AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO BATCH NUMBER C26941. NO BATCH SIGNAL CAN BE IDENTIFIED AT THIS TIME FOR EITHER BATCH. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. AT THE TIME OF THIS MEDICAL ASSESSMENT THE TECHNICAL INVESTIGATION CONCLUDED "UNCONFIRMED QUALITY DEFECT" AND NOTED THAT THE REPORTED BREAKAGE IS AN ANTICIPATED EVENT. BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT, REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED PREVIOUSLY : DURING THE PROCEDURE ON ONE SIDE, ESSURE SYSTEM (C26941) CAME OUT OF THE FALLOPIAN TUBE; THE PHYSICIAN THEN SAW THAT THIS ESSURE SYSTEM WAS BROKEN. THE PATIENT EXPERIENCED PAIN AND BLEEDING WITH ESSURE SYSTEM (C26941). HE TRIED TO PLACE ON THE SECOND SIDE, ESSURE SYSTEM (B85139) AND IT TWISTED DURING THE PLACEMENT. FOLLOWING THESE 2 FAILURES, 2 ESSURE SYSTEMS WERE WELL PLACED AND RAPID OSTIA ESPASM. UPON RECEIPT UPDATED INFORMATION REPORTED BY PHYSICIAN THE EVENTS WERE AMENDED TO PAIN WITH ESSURE SYSTEM, ON THE SECOND SIDE, ESSURE SYSTEM (B85139) TWISTED DURING THE PLACEMENT, RAPID OSTIA SPASM AND COMPLICATION OF DEVICE INSERTION. ALL THE ABOVE REPORTED EVENTS ARE NON-SERIOUS AND LISTED EXCEPT THE EVENT ON THE SECOND SIDE, ESSURE SYSTEM (B85139) TWISTED DURING THE PLACEMENT THAT IS UNLISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. CONSIDERING THAT THE REPORTED EVENTS OCCURRED IN ASSOCIATION WITH ESSURE PLACEMENT PROCEDURE THEIR CAUSAL RELATION WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. IN THIS PARTICULAR CASE, INITIALLY CONSIDERED NEAR-INCIDENT DUE TO REPORTED BREAKAGE AND SERIOUS DUE TO BLEEDING WAS AMENDED TO NON-SERIOUS AND NON-INCIDENT, BECAUSE HEMORRHAGE OCCURRED BEFORE ESSURE INSERTION AND NON-BREAKAGE WAS CONFIRMED DURING FOLLOW-UP. A PRODUCT TECHNICAL ANALYSIS CONCLUDED "UNCONFIRMED QUALITY DEFECT. BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT.
THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A PHARMACIST IN (B)(6) ON (B)(6) 2014, WHICH REFERS TO A FEMALE PT OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) AND EXPERIENCED THE FOLLOWING EVENTS. NO INFORMATION GIVEN ON PT'S HISTORY, PAST DRUGS AND CONCURRENT CONDITIONS. IT WAS NOT REPORTED WHETHER THE PT RECEIVED ANY CONCOMITANT MEDICATION. ON (B)(6) 2014, THE PT HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED, LOT NUMBER C26941 AND B85139. DURING THAT INSERTION PROCEDURE, ON ONE SIDE, PLACEMENT OF ESSURE SYSTEM, LOT NUMBER (C26941) WAS DONE AND SYSTEM WAS RELEASED, BUT AFTER THE CONTROL, THE ESSURE SYSTEM CAME OUT OF THE FALLOPIAN TUBE. AT THE REMOVAL, THE PHYSICIAN SAW THAT ESSURE SYSTEM WAS BROKEN. HE USED A PLIER TO REMOVE THE MISSING PART OF ESSURE SYSTEM. THE PT EXPERIENCED PAIN AND BLEEDING. ANOTHER ESSURE SYSTEM WAS PLACED. ON THE SECOND SIDE, PLACEMENT OF ESSURE SYSTEM, LOT NUMBER (B85139), TUBAL OSTIUM WAS TORTUOUS AND THE ESSURE SYSTEM WAS TWISTED. THE SYSTEM WAS NOT RELEASED AND REMOVED. ANOTHER ESSURE SYSTEM WAS PLACED. AT THE END, FOLLOWING THESE 2 FAILURES, 2 ESSURE SYSTEMS WERE WELL PLACED. THE OUTCOME OF THE REPORTED EVENTS WAS UNK. REPORTER CAUSALITY: THE RELATIONSHIP BETWEEN THE REPORTED EVENTS AND ESSURE WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 435464 | ESSURE | INSERT, TUBAL OCCLUSION | HHS | BAYER PHARMA AG | ESS305 | C26941; B85139 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |