BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT FX DCS

    MDR report key: 18213732 · Received November 27, 2023

    Report

    Report Number
    2025587-2023-04927
    Event Type
    Malfunction
    Date Received
    November 27, 2023
    Date of Event
    May 4, 2023
    Report Date
    December 15, 2023
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000365684
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED: H6 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

    CONTINUATION OF D10: PRODUCT ID EVOLUTFX-34; PRODUCT LOT/SERIAL NUMBER F212381; PRODUCT TYPE: HEART VALVE; PRODUCT ID DRYSEAL INTRODUCER SHEATH; PRODUCT LOT/SERIAL NUMBER UNKNOWN; PRODUCT TYPE: INTRODUCER SHEATH; PRODUCT ID SAFARI ES; PRODUCT LOT/SERIAL NUMBER UNKNOWN; PRODUCT TYPE: GUIDEWIRE PRODUCT ID LUNDI DC; PRODUCT LOT/SERIAL NUMBER UNKNOWN; PRODUCT TYPE: GUIDEWIRE PRODUCT ID EDWARDS; PRODUCT LOT/SERIAL NUMBER UNKNOWN; PRODUCT TYPE: HEART VALVE; IMPLANT DATE: (B)(6) 2023 PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC¿S QUALITY LABORATORY, THE DELIVERY CATHETER SYSTEM (DCS) WAS RECEIVED WITH A VALVE LOADED WITHIN THE CAPSULE. THE DEVICE WAS RECEIVED WITH THE CAPSULE PARTIALLY OPENED. THERE WAS A SLIGHT BEND TO THE CAPSULE. THERE WAS A BEND TO THE STABILITY SHAFT. THE HANDLE APPEARED INTACT. THE DEVICE WAS RETURNED WITH THE END CAP/SCREW GEAR SNAP FIT CONNECTED. ON RETRACTION OF THE CAPSULE VIA THE ROTATION OF THE DEPLOYMENT KNOB, THE VALVE (F212381) DEPLOYED WITH A CROWN OVERLAP. THE DEPLOYMENT KNOB APPEARED TO RETRACT AND ADVANCE THE CAPSULE WITH RESISTANCE NOTED WHEN THE SPINDLE INTERACTED WITH THE CAPSULE TIP. THE TRIGGER MOVED TO FULLY ADVANCED AND RETRACTED POSITIONS AND LOCKED IN PLACE WHEN RELEASED. THE TIP-RETRIEVAL MECHANISM APPEARED INTACT. THE DISTAL END OF THE CAPSULE APPEARED TO BE FLARED. THE CAPSULE TIP APPEARED TO HAVE INVERTED INTO THE CAPSULE UP TO THE NITINOL CROWNS, OF WHICH FIVE NITINOL CROWNS WERE VISIBLE PROTRUDING FROM THE CAPSULE OUTER LAYER. THE INNER MEMBER SHAFT AND SPINDLE HUB APPEARED INTACT WITH NO EVIDENCE OF DAMAGE. THERE WAS DAMAGE OBSERVED ON THE THREADING OF THE SCREW GEAR. THE REPORTED EVENT FOR UNABLE TO ADVANCE COULD NOT BE CONFIRMED IN THE ANALYSIS. THE REPORTED EVENT FOR MISCELLANEOUS, DCS COULD BE CONFIRMED IN THE ANALYSIS DUE TO THE CAPSULE BEING FLARED AND THE CAPSULE TIP BEING INVERTED. 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 IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE VALVE WAS LOADED AND NOT OVERDRIVEN. NO UNUSUAL RESISTANCE WAS FELT DURING VALVE LOADING AND NO MISLOAD WAS REPORTED. IT WAS NOTED THAT THE SALINE SOLUTION THAT THE VALVE WAS LOADED IN WAS VERY COLD AS IT WAS STORED IN THE REFRIGERATOR. THE DELIVERY CATHETER SYSTEM (DCS) WOULD NOT ADVANCE UP THE LEG TOWARDS THE AORTA. IT WAS NOTED THAT THE DCS WAS ABLE TO ADVANCE UP TO THE EXTERNAL ILIAC ARTERY, BUT NOT ANY FARTHER. A DRYSEAL INTRODUCER SHEATH AND THE INLINE SHEATH WERE BOTH USED IN THE ATTEMPTED IMPLANT. A CAPSULE FLARE WAS OBSERVED. IT WAS REPORTED THAT THE CAPSULE FLARE WAS NOT NOTICED PRIOR TO INSERTION OF THE DCS, HOWEVER AS THE DCS WAS NOT ABLE TO BE ADVANCE, THE CAPSULE FLARE WAS "APPRECIATED". THE NON-MEDTRONIC GUIDEWIRE (SAFARI ES) WAS SWITCHED TO ANOTHER NON-MEDTRONIC GUIDEWIRE (LUNDI DC) AND HAD THE SAME RESULT. OF NOTE, THE DIAMETER OF ACCESS VESSEL OF THE LEGS WERE EXTREMELY LARGE; 9 MILLIMETER (MM) TO 11MM. SUBSEQUENTLY, THE DELIVERY CATHETER SYSTEM (DCS) WAS REMOVED AND SWITCH OVER TO A NON-MEDTRONIC VALVE. THE NON-MEDTRONIC VALVE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1765734 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION D-EVOLUTFX-34 0011454415 00763000365684

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male