ESSURE
Report
- Report Number
- 2951250-2014-00423
- Event Type
- Malfunction
- Date Received
- October 9, 2014
- Report Date
- January 19, 2017
- Manufacturer
- BAYER HEALTHCARE LLC
- Product Code
- KNH
- PMA / PMN Number
- P020014
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
FOLLOW-UP FROM 01-APR-2015: THE REQUIRED NUMBER OF FOLLOW-UP ATTEMPTS HAVE BEEN COMPLETED, WITH NO RESPONSE TO DATE. NO FURTHER FOLLOW-UP WILL BE PURSUED. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A (B)(6) FEMALE PATIENT WHO HAD AN ATTEMPT TO INSERT ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) AND WHEN THE PHYSICIAN CANNULATED THE TUBE WITH THE MICRO-INSERT, SHE SAW A SPLIT IN THE PLASTIC SHEATH COVERING. THIS EVENT, INTERPRETED AS DEVICE BREAKAGE, IS NON-SERIOUS AND INITIALLY CONSIDERED AS UNLISTED ACCORDING TO ESSURE REFERENCE SAFETY INFORMATION; HOWEVER UPON RECEIPT OF PRODUCT TECHNICAL INVESTIGATION (PTC) IT WAS AMENDED TO LISTED, SINCE PTC ANALYSIS CONCLUDED THAT THE BREAKAGE IS AN ANTICIPATED EVENT. SINGLE CASES HAVE BEEN REPORTED OF ESSURE BREAKAGE. IN THIS PARTICULAR CASE, THE PHYSICIAN STATED THAT WHEN SHE CANNULATED THE TUBE WITH THE MICRO-INSERT, SHE SAW A SPLIT IN THE PLASTIC SHEATH COVERING THE ESSURE, SO SHE PULLED IT OUT BEFORE DEPLOYING IT. THERE WAS NO INJURY AND BILATERAL PLACEMENT WAS ACHIEVED; CONSIDERING THAT IT IS NOT CLEAR IF THE INSERTER WAS ALREADY BROKEN OR IF IT HAD BROKEN DURING THE INSERTION PROCEDURE, A CAUSAL RELATIONSHIP BETWEEN THE REPORTED EVENT AND SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS OTHER REPORTABLE INCIDENT DUE TO DEVICE BREAKAGE. THE PTC ANALYSIS CONCLUDED TO UNCONFIRMED QUALITY DEFECT. NO FURTHER INFORMATION IS EXPECTED.
THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A MEDICAL DOCTOR IN UNITED STATES ON (B)(6)2014 WHICH REFERS TO A (B)(6) FEMALE PATIENT WHO HAD AN ATTEMPT TO INSERT ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) LOT NUMBER 904753 ON (B)(6) 2014. PHYSICIAN SAID WHEN SHE CANNULATED THE TUBE WITH THE INSERT SHE SAW A SPLIT IN THE PLASTIC SHEATH COVERING THE ESSURE AND SO SHE PULLED IT OUT BEFORE DEPLOYING IT. THERE WAS NO INJURY TO THE PATIENT AND BILATERAL PLACEMENT WAS ACHIEVED AFTER ALL. NO FURTHER INFORMATION WAS PROVIDED. PTC INVESTIGATION RESULT WAS RECEIVED ON (B)(6) 2014. THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: PTC (B)(4). FINAL ASSESSMENT: LOT 904753. EXPIRATION DATE: (B)(4) 2014. PRODUCTION DATE:(B)(4) 2011. WHEN A TERM LIKE "...A SPLIT IN THE PLASTIC SHEATH COVERING.." 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 OR PRODUCT IS RETURNED FOR INVESTIGATION. 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 MICRO-INSERT, 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 MICRO-INSERT. AS OF (B)(4) 2014, 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, THE OUTER CATHETER, THE INNER CATHETER, AND ALL PARTS WITHIN THE HANDLE ASSEMBLY TO CONFIRM THAT ALL ARE WITHIN MANUFACTURING SPECIFICATIONS. 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. SINCE NEITHER PRODUCT WAS RETURNED FOR INSPECTION NOR DO WE HAVE A PHOTOGRAPH OF THE ACTUAL DEVICE, WE CANNOT DETERMINE EXACTLY WHAT THE FAILURE IS. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. CONCLUSIONS: THE POSSIBILITY OF PIECES OF THE DELIVERY SYSTEM OR MICRO-INSERT BREAKING OFF DURING THE PROCEDURE IS AN ANTICIPATED EVENT. ACCORDING TO THE (B)(6), THE MAIN CONSEQUENCE IS A PHYSICIAN INCONVENIENCE BECAUSE THE PROCEDURE COULD NEED TO BE ABORTED OR RESCHEDULED. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A REPORTED PRODUCT QUALITY ISSUE AND USABILITY ISSUES. HOWEVER, NO ADVERSE EVENTS WERE REPORTED AT THIS POINT IN TIME. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER TECHNICAL INVESTIGATION. THE TECHNICAL ASSESSMENT CONCLUDED "UNCONFIRMED QUALITY DEFECT". SINCE NO ADVERSE EVENTS WERE REPORTED NO BATCH SIGNAL REVIEW FOR SIMILAR ADVERSE EVENTS COULD BE CONDUCTED. NO CAUSAL RELATIONSHIP BETWEEN THE REPORTED PRODUCT QUALITY ISSUE AND ADVERSE EVENTS CAN BE ASSESSED, AS NO ADVERSE EVENTS WERE REPORTED AT THIS POINT IN TIME. THE REPORTED USABILITY ISSUES WILL BE SUBJECT TO POST MARKET SURVEILLANCE MONITORING. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A (B)(6) FEMALE PATIENT WHO HAD AN ATTEMPT TO INSERT ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) AND WHEN THE PHYSICIAN CANNULATED THE TUBE WITH THE MICRO-INSERT, SHE SAW A SPLIT IN THE PLASTIC SHEATH COVERING. THIS EVENT, INTERPRETED AS DEVICE BREAKAGE, IS NON-SERIOUS AND INITIALLY CONSIDERED AS UNLISTED ACCORDING TO ESSURE REFERENCE SAFETY INFORMATION; HOWEVER UPON RECEIPT OF PRODUCT TECHNICAL INVESTIGATION (PTC) IT WAS AMENDED TO LISTED, SINCE PTC ANALYSIS CONCLUDED THAT THE BREAKAGE IS AN ANTICIPATED EVENT. SINGLE CASES HAVE BEEN REPORTED OF ESSURE BREAKAGE. IN THIS PARTICULAR CASE, THE PHYSICIAN STATED THAT WHEN SHE CANNULATED THE TUBE WITH THE MICRO-INSERT, SHE SAW A SPLIT IN THE PLASTIC SHEATH COVERING THE ESSURE, SO SHE PULLED IT OUT BEFORE DEPLOYING IT. THERE WAS NO INJURY AND BILATERAL PLACEMENT WAS ACHIEVED; CONSIDERING THAT IT IS NOT CLEAR IF THE INSERTER WAS ALREADY BROKEN OR IF IT HAD BROKEN DURING THE INSERTION PROCEDURE, A CAUSAL RELATIONSHIP BETWEEN THE REPORTED EVENT AND SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS OTHER REPORTABLE INCIDENT DUE TO DEVICE BREAKAGE. THE PTC ANALYSIS CONCLUDED TO UNCONFIRMED QUALITY DEFECT. FURTHER INFORMATION IS BEING SOUGHT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 635010 | ESSURE | DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE | KNH | BAYER HEALTHCARE LLC | ESS305 | 904753 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR |