ESSURE
Report
- Report Number
- 2951250-2014-00387
- Event Type
- Malfunction
- Date Received
- September 16, 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
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
DATA CORRECTION: THE PRODUCT CODE KNH WAS REPLACED WITH HHS.
THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A PHYSICIAN IN UNITED STATES ON (B)(6) 2014 WHICH REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED. ON (B)(6) 2014 ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) WAS INSERTED WITH LOT NUMBER B03097 FOR PERMANENT CONTRACEPTION. SHE WAS NOT PREGNANT AT TIME OF PROCEDURE. IT WAS REPORTED THAT HCP INSERTED AN ESSURE COIL BUT IT DID NOT DEPLOY CORRECTLY. SHE REMOVED COIL BUT A PIECE OF THE GREEN RELEASE WIRE STAYED IN PATIENT AT THE OSTIUM. SHE ATTEMPTED TO REMOVE IT BUT WAS UNABLE. BILATERAL PLACEMENT WITH OTHER COILS WAS SUCCESSFUL. FOLLOW-UP RECEIVED ON (B)(6) 2014: CASE (B)(6) WAS IDENTIFIED AS A DUPLICATE TO THIS CURRENT CASE, (B)(6) WILL BE DELETED FROM (B)(6) DATABASE AND ALL ITS INFORMATION WAS TRANSFERRED TO THIS CASE. NO NEW INFORMATION WAS PROVIDED FOR THIS CASE. FOLLOW-UP INFORMATION FROM (B)(6) 2014: FOLLOW-UP ATTEMPTS WERE DONE WITH NO RESPONSE TO DATE. 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: (B)(4). FINAL ASSESSMENT: WHEN A TERM LIKE "BREAK", "BREAKAGE", "BROKE", "BROKEN", "FALLING APART", "FRACTURED", OR "SPLIT" 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, BREAKAGE OF THE LARGE TIGHT PITCH COIL, OR BREAKAGE OF A PORTION OF THE DELIVERY CATHETER. 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. THE "GREEN-COLORED" MATERIAL REPORTED IS VERY LIKELY THE GREEN HEAT-SHRINK (PET) TUBING WHICH IS A CATHETER ASSEMBLY COMPONENT LOCATED AT THE DISTAL END OF THE INNER CATHETER. 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. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. 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 DFMEA, THE MAIN CONSEQUENCE IS A PHYSICIAN INCONVENIENCE BECAUSE THE PROCEDURE COULD NEED TO BE ABORTED OR RESCHEDULED. MEDICAL ASSESSMENT: THE REPORTED ADVERSE EVENT IS A KNOWN, POSSIBLE, UNDESIRABLE EVENT AND NOT INDICATIVE OF A QUALITY DEFECT PER SE. THE CASE REFERS ALSO TO A TECHNICAL DEFECT IN THE CONTEXT OF THE REPORTED COMPLICATED INSERTION. HOWEVER, THE REPORTED DEFECT COULD NOT BE EVALUATED IN MORE DETAIL DUE TO LACK OF SAMPLE RETURN. ACCORDING TO THE TECHNICAL ASSESSMENT THE POSSIBILITY OF PIECES OF THE DELIVERY SYSTEM OR MICRO-INSERT BREAKING OFF DURING THE PROCEDURE IS AN ANTICIPATED EVENT. THE AE CASE REFERS ALSO TO A USABILITY ISSUE. NO VALID BATCH NUMBER WAS REPORTED. WITHOUT THIS INFORMATION NEITHER A TECHNICAL BATCH EVALUATION NOR A BATCH SIGNAL CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER TECHNICAL INVESTIGATION. ONE FURTHER AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO INVALID BATCH NO. B03097, THIS CASE REFERS ALSO TO SIMILAR ADVERSE AND TECHNICAL TYPES OF EVENTS. NO UNUSUAL PATTERN COULD BE IDENTIFIED. THE REVIEW OF THE MANUFACTURING AND RELEASE DOCUMENTATION OF THE CONCERNED BATCH GAVE NO REASON TO SUSPECT A QUALITY DEFECT. THE TECHNICAL ASSESSMENT CONCLUDED "UNCONFIRMED QUALITY DEFECT". IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. THE REPORTED USABILITY ISSUE WILL BE SUBJECT TO POST MARKET SURVEILLANCE MONITORING. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED REPORT REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND ESSURE COIL DID NOT DEPLOY CORRECTLY; SHE REMOVED COIL BUT A PIECE OF THE GREEN RELEASE WIRE STAYED IN PATIENT AT THE OSTEUM (COMPLICATION OF DEVICE INSERTION) AND SHE ATTEMPTED TO REMOVE IT BUT WAS UNABLE. ALL THE EVENTS ARE CONSIDERED NON-SERIOUS. SHE REMOVED COIL BUT A PIECE OF THE GREEN RELEASE WIRE STAYED IN PATIENT AT THE OSTEUM (ASSUMED AS DEVICE BREAKAGE) WAS REGARDED AS OTHER REPORTABLE INCIDENT DUE TO DEVICE BREAKAGE. UPON RECEIPT OF TECHNICAL INVESTIGATION, THE EVENT SHE REMOVED COIL BUT A PIECE OF THE GREEN RELEASE WIRE STAYED IN PATIENT AT THE OSTEUM, INTERPRETED AS A DEVICE BREAKAGE WAS UPDATED TO LISTED (ANTICIPATED) WHILE THE REMAINING EVENTS ARE LISTED. DURING DIFFICULT INSERTIONS, SINGLE CASES HAVE BEEN REPORTED OF ESSURE BREAKAGE. IN THIS PRESENT CASE, HCP REPORTED THAT DURING ESSURE INSERTION COIL DID NOT DEPLOY CORRECTLY AND A PIECE OF THE GREEN RELEASE WIRE STAYED IN PATIENT AT THE OSTIUM. BASED ON THE AVAILABLE INFORMATION AND DUE TO LACK OF ALTERNATIVE EXPLANATION, CAUSALITY BETWEEN THE EVENTS ABOVE AND ESSURE USE WAS CONSIDERED AS RELATED. THE PTC ANALYSIS STATED THAT THE POSSIBILITY OF PIECES OF THE DELIVERY SYSTEM OR MICRO-INSERT BREAKING OFF DURING THE PROCEDURE IS AN ANTICIPATED EVENT AND CONCLUDED "UNCONFIRMED QUALITY DEFECT". IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 573293 | ESSURE | INSERT, TUBAL OCCLUSION | HHS | BAYER PHARMA AG | ESS305 | B03097 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR |