BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 4093305 · Received September 16, 2014

    Report

    Report Number
    2951250-2014-00383
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 19, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A PHYSICIAN IN UNITED STATES ON (B)(4) 2014. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2014 WHICH CONFIRMED THAT THE ESSURE, LOT NUMBER B66016/B82477, WAS IMPLANTED ON (B)(6) 2014 FOR PERMANENT BIRTH CONTROL IN A (B)(6) FEMALE PATIENT AND THEREFORE THE INITIAL RECEIPT DATE OF THIS CASE WAS AMENDED FROM (B)(4) 2014. THE DOCTOR SAID THAT SHE HAD AN ISSUE WITH A DEPLOYMENT OF ESSURE ON THE RIGHT SIDE DURING A PROCEDURE. NO ISSUES WITH THE LEFT SIDE. BUT WITH THE RIGHT SIDE, SHE DID THE USUAL PROCESS AND THE INSERT WOULD NOT DEPLOY FROM CATHETER PROPERLY AND PROVIDER HAD TO RETRIEVE FROM FALLOPIAN TUBE. SO SHE REMOVED THE INSERTER AND THE COIL BUT THERE WAS A PLASTIC PIECE LEFT IN THE TUBE. SHE ATTEMPTED TO REMOVE WITH GRASPERS BUT IT KEPT BREAKING AND WAS UNABLE. THEY REMOVED THE BROKEN PIECES BUT THERE WAS STILL A SMALL PLASTIC PIECE FROM THE INSERT HANGING OUT THE TUBE. THEY TRIED TO REMOVE BUT IT IS STUCK. I REVIEWED THE PROCEDURE WITH HER AND ASKED HER IF SHE IS SURE THE DEVICE DID NOT DEPLOY. SHE EXAMINED THE END OF THE INSERT AND SAID IT LOOKS LIKE A COIL BUT NOT SURE. THE INSERTER WAS STRETCHED OUT AND UNCOILED. A FLAT PLATE X-RAY WAS PERFORMED AND THEY SEE THE FOUR MARKERS ON THE SIDE IN QUESTION (LEFT SIDE). THE LEFT SIDE COMPARED TO THE RIGHT SIDE WAS VERY SIMILAR. THERE WAS A TRAILING PIECE ON THE END OF THE BRIGHTEST MARKER. SHE SAID THAT THE COIL LOOKED AT FIRST LIKE IT WAS OVERLYING ON ITSELF, BUT THEN THEY CHECKED AT A DIFFERENT ANGLE AND IT LOOKED NORMAL. THE X-RAY CONFIRMED THAT THE INSERT WAS IN FACT DEPLOYED AND SHOULD EVAL IT AT 3 MONTHS HSG. THE PATIENT WAS ADVISED TO USE BACKUP CONTRACEPTION. PTC INVESTIGATION RESULT WAS RECEIVED ON 08-SEP-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 "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. AS OF 9/03/2014, 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, 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 RECORDS AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THESE LOTS WERE PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. 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 EVENTS ARE 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 (SEE TECHNICAL ASSESSMENT). 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. 2 FURTHER AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO BATCH NO. B66016 (PRODUCTION DATE 28-AUG-2013, EXPIRATION DATE 31-AUG-2016), BOTH REFERRING TO SIMILAR ADVERSE TYPES OF EVENTS BUT NONE TO SIMILAR TECHNICAL TYPES OF EVENTS, THIS CASE REFERS ALSO TO SIMILAR ADVERSE AND TECHNICAL TYPES OF EVENTS. 2 FURTHER AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO BATCH NO. B82477 (PRODUCTION DATE 16-OCT-2013, EXPIRATION DATE 31-OCT-2016), BOTH REFERRING TO SIMILAR ADVERSE TYPES OF EVENTS BUT NONE TO SIMILAR TECHNICAL TYPES OF EVENTS, 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 (SEE TECHNICAL STATEMENT). 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. FOLLOW-UP INFORMATION FROM 09-SEP-2014: FOLLOW-UP ATTEMPTS WERE DONE WITH NO RESPONSE TO DATE. FOLLOW-UP RECEIVED ON 09-SEP-2014: INFORMATION RECEIVED FROM PHYSICIAN STATES THAT A (B)(6) FEMALE PATIENT WHO IS OBESE AND HAS AS PREVIOUS GYNECOLOGICAL INTERVENTIONS A CERVICAL CONIZATION AND A CURETTAGE BOTH PERFORMED IN 1998, A SALPINGECTOMY ON THE LEFT DUE TO ECTOPIC WHICH WAS PERFORMED IN 1995, AND NO PREVIOUS IUS/IUD NOR MYOMECTOMY AND, HAS AS PREVIOUS GYNECOLOGICAL PROBLEMS OR PROCEDURES, A CERVICAL DYSPLASIA AND A ECTOPIC PREGNANCY ON THE RIGHT; HAD ESSURE (MODEL ESS305, LOT NUMBER B66016) INSERTED. INSERTION WAS NOT PERFORMED POST-PARTUM AND NO CERVICAL DILATATION, SOUNDING, OR GENERAL ANESTHESIA WAS APPLIED DURING INSERTION. ANALGESIA WITH TORADOL WAS DONE. IN ADDITION PHYSICIAN STATES THAT THE INSERTION ON THE LEFT TUBE WAS VERY EASY, HOWEVER, THE RIGHT TUBE WAS DIFFICULT DUE TO TUBAL SPASM. THE VISUALIZATION OF TUBAL OSTIUM WAS DESCRIBED AS EASY BY HEALTH CARE PROFESSIONAL; THERE WAS NO LOSS MORE THAN 1500CC DURING HYSTEROSCOPY AND THE PROCEDURE TOOK 35 MINUTES. ON (B)(6) 2014 AN IMAGING TEST (FLUOROSCOPY) WAS PERFORMED AND SHOWED THAT MICRO-INSERT WAS NOT IN THE RIGHT TUBE AND ALSO RIGHT SIDE APPEARS TO BE PERFORATED. AS BACK-UP CONTRACEPTION AFTER ESSURE INSERTION AND BEFORE TOTAL OCCLUSION CONFIRMATION PATIENT TOOK PROGESTIN ONLY ORAL CONTRACEPTIVE. NO HYSTEROSALPINGOGRAM WAS PERFORMED YET, THERE WAS NO SIGNAL OF INFECTION OR INFLAMMATION AND NO HOSPITALIZATION WAS REQUIRED. IN ADDITION PHYSICIAN HAS CONFIRMED THE EVENTS AND DETAILS AND REPORTED THAT A PERFORATION OCCURRED AND STATES THAT IT WAS ABSOLUTELY RELATED TO ESSURE DEVICE. NO TREATMENT WAS PROVIDED. REGARDING THE EVENTS, REPORTER SUSPECTS THAT ESSURE DEVICES CAUSED OR CONTRIBUTED TO THE ISSUE. THE REMOVAL WAS NOT PERFORMED AND IS NOT PLANNED AT THIS TIME. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS MEDICALLY CONFIRMED CASE REPORT REFERS TO A (B)(6) FEMALE PATIENT WHO HAD AN ATTEMPT OF ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTION AND EXPERIENCED MICROINSERT NOT IN TUBE ON R/ FLUOROSCOPY APPEARS THAT RIGHT SIDE WAS PERFORATED, ATTEMPTED TO REMOVE PLASTIC BUT WAS UNABLE TO, IT KEPT BREAKING, INSERT DID NOT DEPLOY FROM CATHETER PROPERLY AND PROVIDER HAD TO RETRIEVE FROM FALLOPIAN, PLASTIC PIECE IN OSTIUM/ON X-RAY THE TRAILING PIECE ON THE END OF THE BRIGHTEST MARKER (COMPLICATION OF DEVICE INSERTION) AND FAILED INSERTION. THE FIRST TWO EVENTS ARE SERIOUS DUE MEDICAL IMPORTANCE, WHEREAS THE OTHER EVENTS WERE CONSIDERED NON-SERIOUS. ALL EVENTS ARE LISTED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. THE EVENT PLASTIC PIECE IN OSTIUM/ ON X-RAY THE TRAILING PIECE ON THE END OF THE BRIGHTEST MARKER WAS REGARDED AS OTHER REPORTABLE INCIDENT DUE TO THE REPORTED BREAKAGE. DURING DIFFICULT INSERTION/REMOVALS, SINGLE CASES HAVE BEEN REPORTED OF ESSURE BREAKAGE. IN THIS PARTICULAR CASE IT WAS REPORTED THAT INSERT DID NOT DEPLOY FROM CATHETER PROPERLY AND PROVIDER HAD TO RETRIEVE FROM FALLOPIAN TUBE. ONCE RETRIEVED, PROVIDER NOTICED A PLASTIC PIECE IN OSTIUM. AFTER FLAT PLATE X-RAY PERFORMED THE LEFT SIDE COMPARED TO THE RIGHT SIDE WAS VERY SIMILAR. ALTHOUGH THERE WAS A TRAILING PIECE ON THE END OF THE BRIGHTEST MARKER. LATER, IT WAS REPORTED THAT AN IMAGING TEST (FLUOROSCOPY) WAS PERFORMED AND SHOWED THAT MICRO-INSERT WAS NOT IN THE RIGHT TUBE AND ALSO RIGHT SIDE APPEARS TO BE PERFORATED. THEREFORE, A CAUSAL RELATIONSHIP BETWEEN THE REPORTED EVENTS AND ESSURE CANNOT BE EXCLUDED. PRODUCT TECHNICAL COMPLAINT (PTC) ANALYSIS CONCLUDED TO AN UNCONFIRMED QUALITY DEFECT. MEDICAL PTC ASSESSMENT CONSIDERED THAT, BASED ON THE AVAILABLE INFORMATION, THERE IS NO REASON TO SUSPECT QUALITY DEFECT OF THE PRODUCT. THE EVENT PLASTIC PIECE IN OSTIUM/ ON X-RAY THE TRAILING PIECE ON THE END OF THE BRIGHTEST MARKER, INTERPRETED AS A DEVICE BREAKAGE AND PREVIOUSLY CONSIDERED UNLISTED ACCORDING TO REFERENCE SAFETY INFORMATION FOR ESSURE, WAS, UPON RECEIPT OF PRODUCT TECHNICAL INVESTIGATION (PTC) UPDATED TO LISTED (ANTICIPATED). FURTHER INFORMATION WILL BE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571637 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 B66016/B82477

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other ORAL CONTRACEPTIVE NOS (ORAL CONTRACEPTIVE NOS)