BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX DCS

    MDR report key: 16947055 · Received May 17, 2023

    Report

    Report Number
    2025587-2023-02091
    Event Type
    Malfunction
    Date Received
    May 17, 2023
    Date of Event
    February 8, 2023
    Report Date
    June 5, 2023
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. PROCEDURAL IMAGES WERE PROVIDED FOR REVIEW. TWO IMAGES ARE FLUOROSCOPIC INSPECTIONS OF THE MEDTRONIC BIOPROSTHETIC VALVE, BOTH OF WHICH ARE MISLOADS. IMAGE ONE SHOWS A MISLOAD OF CROWN OVERLAP PAST THE FORTH NODE. IMAGE TWO SHOWS ANOTHER VALVE LOAD WITH A PADDLE OUT OF THE POCKET. A THIRD IMAGE SHOWS A PARTIALLY DEPLOYED MEDTRONIC TRANSCATHETER VALVE WITH AN INFOLD PRESENT. THE EXACT ROOT CAUSE OF CAPSULE BUCKLE IS UNKNOWN HOWEVER, PATIENT ANATOMY (VESSEL TORTUOSITY & CALCIFICATION) AND USE CONDITIONS DUE TO CHALLENGING ANATOMY (INSERTION ANGLE, FORCE REQUIRED TO ADVANCE, TORQUEING OF THE CATHETER) ARE KNOWN POTENTIAL CONTRIBUTING FACTORS TO CAPSULE DAMAGE. DELAMINATION WAS OBSERVED OVER THE NITINOL REINFORCING FRAME ON THE PROXIMAL END OF THE CAPSULE AT THE SITE OF THE PROXIMAL SLIGHT BUCKLE, WHICH TYPICALLY OCCURS WHEN THE CAPSULE IS SUBJECTED TO A BENDING FORCE POTENTIALLY AFTER A MISLOAD HAS OCCURRED. LOADING OF THE VALVE IS A PROCESS IN WHICH THE OUTCOME IS HIGHLY DEPENDENT ON THE OPERATOR EXPERIENCE AND TECHNIQUE. THE EVOLUT FX I NSTRUCTIONS FOR USE (IFU) CONTAIN INSTRUCTIONS TO USE THE INTEGRATED LOADING BATH WHICH FEATURES A MIRROR TO ENSURE THAT ALL BIOPROSTHESIS OUTFLOW STRUTS ARE SYMMETRICAL AND CAPTURED IN THE CAPSULE DURING LOADING. IN ADDITION, THE IFU INSTRUCTS TO INSPECT THE CAPSULE VISUALLY AND TACTILELY FOR A MISLOADED BIOPROSTHESIS. IN THIS CASE, THE INSPECTION PROCESS PER THE IFU WAS PERFORMED AND IDENTIFIED THE REPORTED MISLOAD PRIOR TO INTRODUCTION TO THE PATIENT. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC¿S QUALITY LABORATORY, THE DELIVERY CATHETER SYSTEM (DCS) WAS RECEIVED WITH A VALVE LOADED WITHIN THE CAPSULE. THE HANDLE APPEARED INTACT. THE DEVICE WAS RECEIVED WITH THE CAPSULE FULLY CLOSED. THERE WAS A SLIGHT BUCKLE TO THE PROXIMAL END OF THE CAPSULE AND A VERY SLIGHT BUCKLE TO THE DISTAL END OF THE CAPSULE. ON RETRACTION OF THE CAPSULE VIA THE ROTATION OF THE DEPLOYMENT KNOB, THE VALVE DEPLOYED WITH A BENT PADDLE STRUT. THE DEPLOYMENT KNOB APPEARED TO RETRACT AND ADVANCE THE CAPSULE WITH RESISTANCE NOTED. THE TRIGGER MOVED TO FULLY ADVANCED AND RETRACTED POSITIONS WITH RESISTANCE NOTED AND LOCKED IN PLACE WHEN RELEASED. THE TIP-RETRIEVAL MECHANISM APPEARED INTACT WITH SLIGHT RESISTANCE NOTED WHEN TESTED. THE DEVICE WAS RETURNED WITH THE END CAP/SCREW GEAR SNAP FIT CONNECTED. DELAMINATION WAS OBSERVED OVER THE NITINOL REINFORCING FRAME ON THE PROXIMAL END OF THE CAPSULE AT THE SITE OF THE PROXIMAL SLIGHT BUCKLE. THE INNER MEMBER SHAFT AND SPINDLE HUB APPEARED INTACT WITH NO EVIDENCE OF DAMAGE. AN EVOLUTFX 34MM VALVE (D529658) WAS SUCCESSFULLY LOADED ONTO THE DCS WITH SLIGHT RESISTANCE NOTED. AFTER THE SUCCESSFUL LOADING OF THE VALVE ONTO THE CATHETER THERE WAS NO EVIDENCE OF A MISLOAD ON THE CAPSULE. ON RETRACTION OF THE CAPSULE VIA THE ROTATION OF THE DEPLOYMENT KNOB, THE VALVE DEPLOYED WITH SLIGHT RESISTANCE NOTED. CONCLUSION: THE INVESTIGATION IS IN PROGRESS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE (F173535), A MISLOAD WAS IDENTIFIED VIA FLUOROSCOPY. IT WAS REPORTED THAT A PADDLE WAS OUT OF THE POCKET. THE VALVE WAS LOADED BY A NURSE IN TRAINING. THE VALVE WAS NOT USED. A NEW VALVE (F186740) WAS LOADED AND AN OUTFLOW INFOLD WAS REPORTED VIA FLUOROSCOPY. THIS VALVE WAS LOADED BY AN EXPERIENCED LOADER. THE VALVE WAS NOT USED. A THIRD VALVE (D690031) WAS LOADED SUCCESSFULLY. THE VALVE WAS DEPLOYED TOO VENTRICULAR AND WAS RECAPTURED. UPON THE SECOND PARTIAL DEPLOYMENT, IT WAS NOTED THAT THE VALVE WAS UNDER-EXPANDED AND AN INFOLD WAS SEEN. THE VALVE WAS RECAPTURED AND REMOVED FROM THE PATIENT. A NON-MEDTRONIC VALVE WAS USED. PER THE PHYSICIAN, THE LEFT CAROTID ACCESS CONTRIBUTED TO THE INFOLD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501561 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION D-EVOLUTFX-34 0011386113

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown