ESSURE
Report
- Report Number
- 2951250-2014-00249
- Event Type
- Malfunction
- Date Received
- June 25, 2014
- Report Date
- January 19, 2017
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
THIS MEDICALLY CONFIRMED REPORT REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE WHO HAD AN ATTEMPT OF ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTION AND EXPERIENCED "PROVIDER NOTICED THERE WAS A SMALL PIECE OF METAL AT THE TIP THAT LOOKED LATER TO THE TUBE / PIECES RETRIEVED, PROVIDER BENT THE OTHER COIL, DEVICE FAILED INSERTION AND COMPLICATION OF DEVICE INSERTION." ALL THE EVENTS ARE CONSIDERED NON-SERIOUS. "PROVIDER NOTICED THERE WAS A SMALL PIECE OF METAL AT THE TIP THAT LOOKED LATERAL TO THE TUBE / PIECES RETRIEVED" IS UNLISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE, WHILE THE REMAINING EVENTS ARE LISTED. THE EVENT "PROVIDER NOTICED THERE WAS A SMALL PIECE OF METAL AT THE TIP THAT LOOKED LATER TO THE TUBE / PIECES RETRIEVED" (ASSUMED AS DEVICE BREAKAGE) WAS REGARDED AS NEAR-INCIDENT DUE TO THE REPORTED BREAKAGE. DURING DIFFICULT INSERTION, SINGLE CASES HAVE BEEN REPORTED OF ESSURE BREAKAGE. IN THIS PRESENT CASE, IT WAS MENTIONED THAT THE PHYSICIAN NOTICED THAT THERE WAS A SMALL PIECE OF METAL AT THE TIP THAT LOOKED LATERAL TO THE TUBE ON ONE COIL. PHYSICIAN BENT THE OTHER COIL SOMEHOW. PHYSICIAN REPORTED THAT BILATERAL PLACEMENT WAS NOT SUCCESSFUL, AND THAT THE PIECES WERE RETRIEVED. BASED ON THE AVAILABLE INFORMATION AND DUE TO LACK OF ALTERNATIVE EXPLANATION, CAUSALITY BETWEEN THE EVENTS ABOVE AND ESSURE USE WAS CONSIDERED RELATED. THE EVENT "PROVIDER BENT THE OTHER COIL" WAS CONSIDERED DEVICE USE ERROR AND UNRELATED TO ESSURE. PTC ANALYSIS WILL BE SOUGHT.
DATA CORRECTION FOR US REPORTING. THE CODE (B)(4) WAS REPLACED WITH (B)(4).
FOLLOW-UP FROM (B)(4) 2014: THE REQUIRED NUMBER OF FOLLOW-UP ATTEMPTS HAS BEEN MADE, WITH NO RESPONSE TO DATE. PTC INVESTIGATION RESULT WAS RECEIVED ON (B)(4) 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 (B)(4) AND PTC GLOBAL NUMBER (B)(4). FINAL ASSESSMENT: WHEN A TERM LIKE "BROKE" 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: THIS CASE REPORTED COMPLICATION OF INSERTION DUE TO BREAKAGE AS WELL AS USE ERROR WITH BENT COIL. THE REPORTED EVENTS ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. ONE (1) ADDITIONAL AE CASE REPORT HAS BEEN RECEIVED TO DATE IN RELATION TO BATCH NUMBER B53031 WHICH REFERS TO A SIMILAR BREAKAGE AND USE ERROR EVENTS. NO UNUSUAL PATTERN CAN BE IDENTIFIED AT THIS TIME. THE REVIEW OF THE LOT HISTORY RECORDS CONFIRMED THAT THE PRODUCT MET PRODUCT RELEASE SPECIFICATIONS. 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 BREAKAGE DURING THE PROCEDURE IS AN ANTICIPATED EVENT. BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED REPORT REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE WHO HAD AN ATTEMPT OF ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTION AND EXPERIENCED PROVIDER NOTICED THERE WAS A SMALL PIECE OF METAL AT THE TIP THAT LOOKED LATERAL TO THE TUBE / PIECES RETRIEVED , PROVIDER BENT THE OTHER COIL , DEVICE FAILED INSERTION AND COMPLICATION OF DEVICE INSERTION. ALL THE EVENTS ARE CONSIDERED NON-SERIOUS .UPON RECEIPT OF TECHNICAL INVESTIGATION,THE EVENT PROVIDER NOTICED THERE WAS A SMALL PIECE OF METAL AT THE TIP THAT LOOKED LATERAL TO THE TUBE / PIECES RETRIEVED, INTERPRETED AS A DEVICE BREAKAGE AND PREVIOUSLY CONSIDERED UNLISTED ACCORDING TO REFERENCE SAFETY INFORMATION FOR ESSURE, WAS UPDATED TO LISTED (ANTICIPATED).THE OTHER EVENTS ARE LISTED EITHER. THE EVENT PROVIDER NOTICED THERE WAS A SMALL PIECE OF METAL AT THE TIP THAT LOOKED LATERAL TO THE TUBE / PIECES RETRIEVED (ASSUMED AS DEVICE BREAKAGE) WAS REGARDED AS NEAR-INCIDENT DUE TO THE REPORTED BREAKAGE. DURING DIFFICULT INSERTION, SINGLE CASES HAVE BEEN REPORTED OF ESSURE BREAKAGE. IN THIS PRESENT CASE, IT WAS MENTIONED THAT THE PHYSICIAN NOTICED THAT WAS A SMALL PIECE OF METAL AT THE TIP THAT LOOKED LATERAL TO THE TUBE ON ONE COIL. PHYSICIAN BENT THE OTHER COIL, SOMEHOW. PHYSICIAN REPORTED THAT BILATERAL PLACEMENT WAS NOT SUCCESSFUL; AND THAT THE PIECES WERE RETRIEVED. BASED ON THE AVAILABLE INFORMATION AND DUE TO LACK OF ALTERNATIVE EXPLANATION , CAUSALITY BETWEEN THE EVENTS ABOVE AND ESSURE USE WAS CONSIDERED AS RELATED. EXCEPT THE EVENT PROVIDER BENT THE OTHER COIL WAS CONSIDERED DEVICE USE ERROR AND UNRELATED TO ESSURE. PTC ANALYSIS CONCLUDED "UNCONFIRMED QUALITY DEFECT" AND NOTED BREAKAGE DURING THE PROCEDURE IS AN ANTICIPATED EVENT. BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT.
THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A MEDICAL DOCTOR IN UNITED STATES ON (B)(6)-2014 WHICH REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED THE FOLLOWING EVENT. ON (B)(6)-2014, ESSURE WAS INSERTED FOR PERMANENT BIRTH CONTROL, LOT NUMBER B53031. THE PHYSICIAN NOTICED THAT WAS A SMALL PIECE OF METAL AT THE TIP THAT LOOKED LATERAL TO THE TUBE ON ONE COIL. PHYSICIAN BENT THE OTHER COIL SOMEHOW. PHYSICIAN REPORTED THAT BILATERAL PLACEMENT WAS NOT SUCCESSFUL, AND THAT THE PIECES WERE RETRIEVED. SHE REPORTED THAT THE PATIENT HAD NO INJURIES. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 370675 | ESSURE | INSERT, TUBAL OCCLUSION | HHS | BAYER PHARMA AG | ESS305 | B53031 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |