BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 4802091 · Received May 28, 2015

    Report

    Report Number
    2951250-2015-00348
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP FROM 29-SEP-2015: THE REQUIRED NUMBER OF FOLLOW-UP ATTEMPTS HAVE BEEN COMPLETED, WITH NO RESPONSE TO DATE. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE PATIENT, WHO HAD AN ATTEMPT TO INSERT ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) AND DURING PLACEMENT INTO RIGHT SIDE THE DEPLOYMENT FAILED AND THE PHYSICIAN TRIED TO REMOVE THE MICRO-INSERT AND THE INNER COIL FRACTURED INTO TWO PIECES. THIS EVENT, SEEN AS DEVICE BREAKAGE, IS NON-SERIOUS. THIS EVENT IS LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. HOWEVER, ACCORDING TO PRODUCT TECHNICAL COMPLAINT (PTC) ANALYSIS, MICRO-INSERT BREAKING DURING THE PROCEDURE IS AN ANTICIPATED EVENT. SINGLE CASES OF ESSURE BREAKAGE HAVE BEEN REPORTED, MOSTLY DURING DIFFICULT INSERTIONS OR REMOVALS. IN THIS CASE, THE PHYSICIAN WAS INSERTING ESSURE INTO RIGHT SIDE BUT THE SPRING DID NOT RELEASE FROM THE OUTER COIL. THE DEVICE DID NOT COME OUT. SHE TRIED TO REMOVE THE MICROINSERT AND THE INNER COIL FRACTURED INTO TWO PIECES. THE HCP REMOVED HALF OF THE INNER COIL BUT IT STRETCHED OUT. SHE USED THE GRASPERS TO ATTEMPT TO REMOVE THE OTHER HALF BUT IT FAILED AND WAS LEFT BEHIND. SHE THEN ABORTED THE PROCEDURE. CONSIDERING THE EVENT OCCURRED ASSOCIATED TO INSERTION PROCEDURE, CAUSALITY WITH ESSURE USE CANNOT BE EXCLUDED. THIS CASE IS ASSESSED AS OTHER REPORTABLE INCIDENT SINCE THE BREAKAGE IN THIS REPORT DID NOT LEAD TO SERIOUS INJURY, HOWEVER, IT MIGHT HAVE LED UNDER LESS FORTUNATE CIRCUMSTANCES. THE PRODUCT TECHNICAL ANALYSIS CONCLUDED THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. FURTHER INFORMATION COULD NOT BE OBTAINED.

    Additional Manufacturer Narrative · 1

    DATA CORRECTION: THE PRODUCT CODE KNH WAS REPLACED WITH HHS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A MEDICAL DOCTOR IN UNITED STATES ON (B)(6) 2015 WHICH REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE WHO HAD AN ATTEMPT TO INSERT ESSURE (FALLOPIAN TUBE OCCLUSION INSERT), LOT NUMBER C51060, ON (B)(6) 2015. HEALTH CARE PROFESSIONAL REPORTED THAT SHE WAS INSERTING ESSURE INTO THE RIGHT SIDE AND ALL WAS GOING WELL UNTIL SHE PRESSED THE BUTTON. SOMETHING WENT WRONG, THE DEVICE WAS NOT COMING OUT PROPERLY AND ON THE SECOND WHEEL BACK THE SPRING DID NOT RELEASE FROM THE OUTER COIL (THE INSERTER DID NOT COME OUT AT ALL). IT WAS NOT CLEAR WHETHER PHYSICIAN MEANT THE DELIVERY CATHETER OR MICRO-INSERT. PHYSICIAN TRIED TO REMOVE THE MICRO-INSERT AND THE INNER COIL FRACTURED INTO TWO PIECES. THE HCP REMOVED HALF OF THE INNER COIL BUT IT STRETCHED OUT. SHE REINSERTED THE CAMERA AND USED THE GRASPERS TO ATTEMPT TO REMOVE THE OTHER HALF AND IT WOULD NOT REMOVE AND WAS LEFT BEHIND. SHE THEN ABORTED THE PROCEDURE. THE LEFT SIDE WAS NOT ATTEMPTED. PTC INVESTIGATION RESULT RECEIVED ON (B)(6) 2015. PTC GLOBAL NUMBER (B)(4). FINAL ASSESSMENT: 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 ALL IFU STEPS HAVE NOT BEEN COMPLETED, USER ATTEMPTS TO REPOSITION OR REMOVE THE CATHETER ASSEMBLY COULD LEAD TO EITHER A STRETCHING OR BREAKAGE OF THE MICRO-INSERT OR A PART OF THE 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. 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. 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 WERE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. THE POSSIBILITY OF MICRO-INSERT BREAKING DURING THE PROCEDURE AND DETACHMENT DIFFICULTY IS AN ANTICIPATED EVENT. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A PRODUCT QUALITY ISSUE REPORTED IN THE CONTEXT OF A COMPLICATED DEVICE REMOVAL. THE AE CASE REFERS TO A USABILITY ISSUE. HOWEVER, NO ADVERSE EVENTS HAVE BEEN REPORTED. THE BATCH DOCUMENTATION OF THE REPORTED BATCH WAS REVIEWED. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. SINCE NO ADVERSE EVENTS HAVE BEEN REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE, WHO HAD AN ATTEMPT TO INSERT ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) AND DURING PLACEMENT INTO RIGHT SIDE THE DEPLOYMENT FAILED AND THE PHYSICIAN TRIED TO REMOVE THE MICRO-INSERT AND THE INNER COIL FRACTURED INTO TWO PIECES. THIS EVENT, SEEN AS DEVICE BREAKAGE, IS NON-SERIOUS. THIS EVENT IS LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. HOWEVER, ACCORDING TO PRODUCT TECHNICAL COMPLAINT (PTC) ANALYSIS, MICRO-INSERT BREAKING DURING THE PROCEDURE IS AN ANTICIPATED EVENT. SINGLE CASES OF ESSURE BREAKAGE HAVE BEEN REPORTED, MOSTLY DURING DIFFICULT INSERTIONS OR REMOVALS. IN THIS CASE, THE PHYSICIAN WAS INSERTING ESSURE INTO RIGHT SIDE BUT THE SPRING DID NOT RELEASE FROM THE OUTER COIL. THE DEVICE DID NOT COME OUT. SHE TRIED TO REMOVE THE MICROINSERT AND THE INNER COIL FRACTURED INTO TWO PIECES. THE HCP REMOVED HALF OF THE INNER COIL BUT IT STRETCHED OUT. SHE USED THE GRASPERS TO ATTEMPT TO REMOVE THE OTHER HALF BUT IT FAILED AND WAS LEFT BEHIND. SHE THEN ABORTED THE PROCEDURE. CONSIDERING THE EVENT OCCURRED ASSOCIATED TO INSERTION PROCEDURE, CAUSALITY WITH ESSURE USE CANNOT BE EXCLUDED. THIS CASE IS ASSESSED AS OTHER REPORTABLE INCIDENT SINCE THE BREAKAGE IN THIS REPORT DID NOT LEAD TO SERIOUS INJURY, HOWEVER, IT MIGHT HAVE LED UNDER LESS FORTUNATE CIRCUMSTANCES. THE PRODUCT TECHNICAL ANALYSIS CONCLUDED THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345993 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 C51060

    Patients

    Seq Age Sex Outcome Treatment
    1