BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-X PROSTHETIC MITRAL VALVE 27/29

    MDR report key: 6562173 · Received May 11, 2017

    Report

    Report Number
    1649833-2017-00049
    Event Type
    Malfunction
    Date Received
    May 11, 2017
    Report Date
    July 10, 2017
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE RETURNED SAMPLE SUGGESTS THAT THE VALVE WAS ROTATED WITH AN UNDERSIZED ROTATOR. ONE LEAFLET WAS LODGED BETWEEN THE FLATS OF THE HOUSING AND THE OTHER HAD BEEN FORCED OUT OF THE HOUSING. BY DESIGN, A PROPERLY SIZED ROTATOR WILL EXERT FORCE ONLY AGAINST THE HOUSING FLATS WHEN ROTATING THE VALVE. RESIDUAL IRON AND CHROMIUM INDICATE THAT THE VALVE HAD CONTACT WITH STAINLESS STEEL INSTRUMENTATION. THIS IS IN DIRECT CONTRADICTION TO THE 010122 02 REV. M, INSTRUCTIONS FOR USE, SECTION 4.2: 4.2 PRECAUTIONS AND 8.4 ACCESSORIES "HANDLE THE PROSTHESIS WITH ONLY ON-X LIFE TECHNOLOGIES, INC. (ON-XLTL) ON-X PROSTHETIC HEART VALVE INSTRUMENTS." THIS CONTACT MAY HAVE OCCURRED DURING EXPLANT WHERE THE PRECAUTION WOULD NOT HAVE APPLIED. ROOT CAUSE FOR THIS EVENT IS IATROGENIC, EVIDENCE SUGGESTS THAT THE VALVE WAS ROTATED USING AN UNDERSIZED ROTATOR. IF A STAINLESS STEEL INSTRUMENT WAS NOT USED DURING EXPLANT, IT SUGGESTS THE VALVE MAY HAVE BEEN GRASPED BY A HEMOSTAT OR SIMILAR METALLIC INSTRUMENT AND MANIPULATED WITH SUFFICIENT FORCE TO PUSH THE LEAFLET OUT OF THE HOUSING. THE MANUFACTURING RECORDS FOR THE ONXM-27/29 SN (B)(4) WERE REVIEWED AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. ALL LOTS PASSED FUNCTIONAL TESTING AND MET RELEASE SPECIFICATIONS. DURING THE INVESTIGATION NO NON-CONFORMANCES OR DEVIATIONS WERE NOTED. DURING THE IMPLANTATION PROCESS, ROTATION OF THE ONXM-27/29 SN (B)(4) VALVE IN-SITU RESULTED IN RELEASE OF ONE LEAFLET FROM THE HOUSING AND DISLOCATION OF THE OTHER OUT OF ONE OF ITS PIVOTS. THE VALVE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. PHOTOS OF THE VALVE ARE AVAILABLE IN THE RESULTING SAMPLE EVALUATION REPORT. THE SURGICAL TECHNICIAN REPORTS THAT NO METAL TOUCHED THE VALVE AND THAT THE SURGEON WAS STRUGGLING TO TURN (I.E. ROTATE) THE VALVE. THE TECHNICIAN FURTHER INSISTED THAT THE CORRECT ROTATOR SIZE WAS UTILIZED. THE ROTATOR IS DESIGNED TO CONTACT THE FLATS OF THE HOUSING ID RATHER THAN THE LEAFLETS SO THAT THE ROTATIONAL FORCE IS APPLIED DIRECTLY TO THE HOUSING THEREBY AVOIDING THE APPLICATION OF FORCE ON THE LEAFLETS. THE PHYSICAL EVIDENCE OF THE RETURNED VALVE IS TYPICAL OF LEAFLETS DISLOCATED WHEN THE WRONG SIZED ROTATOR IS USED IN AN ATTEMPT TO ROTATE A VALVE WHOSE ROTATION FEATURE IS IMPEDED. IN SUCH A CASE, THE INTENDED CONTACT BETWEEN THE ROTATOR AND HOUSING FLATS IS UNREALIZED WHILE THE UNINTENDED CONTACT WITH THE LEAFLETS PLACES UNDUE STRAIN ON THEM. EVEN SO, IT TAKES CONSIDERABLE FORCE TO SNAP THE LEAFLETS OUT OF THEIR PIVOTS. THE INSTRUCTIONS FOR USE STATE "CAUTION: DO NOT ATTEMPT TO ROTATE THE VALVE IF ANY SIGNIFICANT RESISTANCE TO ROTATION IS ENCOUNTERED. THE TORQUE REQUIRED TO ROTATE THE VALVE IN SITU SHOULD BE ABOUT THE SAME AS THAT REQUIRED WHEN TESTING ROTATION BEFORE IMPLANTATION. IF NOTICEABLY GREATER TORQUE IS REQUIRED TO ROTATE, STOP ATTEMPTING ROTATION. IF ROTATION IS NECESSARY AND CANNOT BE PERFORMED, REMOVE THE VALVE." IF THE PROPERLY SIZED ROTATOR WAS USED, WHAT ACCOUNTS FOR DISLODGED LEAFLETS REMINISCENT OF AN IMPROPERLY SIZED ROTATOR? A FULLY INSERTED AND PROPERLY SIZED ROTATOR, BY DESIGN, WOULD NOT PERMIT ROTATIONAL FORCE TO BE APPLIED TO THE LEAFLETS. THEREFORE, IT IS PROBABLE THAT THE ROTATOR WAS NOT FULLY INSERTED DURING THE ATTEMPT AT ROTATION AND THAT CONTACT BETWEEN THE ROTATOR AND LEAFLETS WAS REINSTATED WITH A RESULT AKIN TO A MIS-SIZED ROTATOR. IT IS ALSO EVIDENT THAT A TORQUE EXCEEDING THE SAFE LIMIT WAS APPLIED IN THE ATTEMPT. ROOT CAUSE FOR THIS EVENT IS INADEQUATELY ENGAGED ROTATOR WITH EXCESSIVE APPLICATION OF TORQUE. NO FURTHER ACTION WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    ACCORDING TO CRYOLIFE REPRESENTATIVE, "A LEAFLET ON AN ON-X VALVE WAS DETACHED DURING IMPLANT WHEN SURGEON ATTEMPTED TO ROTATE THE VALVE." ADDITIONAL INFORMATION INDICATES "NO METAL TOUCHED THE VALVE, THE CORRECT SIZER [ROTATOR] WAS USED TO TURN THE VALVE, PATIENT IS OKAY."

    Description of Event or Problem · 1

    ACCORDING TO CRYOLIFE REPRESENTATIVE, "A LEAFLET ON AN ON-X VALVE WAS DETACHED DURING IMPLANT WHEN SURGEON ATTEMPTED TO ROTATE THE VALVE." ADDITIONAL INFORMATION INDICATES "NO METAL TOUCHED THE VALVE, THE CORRECT SIZER [ROTATOR] WAS USED TO TURN THE VALVE, PATIENT IS OKAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343125 ON-X PROSTHETIC MITRAL VALVE 27/29 HEART VALVE MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC ONXM-27/29

    Patients

    Seq Age Sex Outcome Treatment
    1