BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 8113913 · Received November 28, 2018

    Report

    Report Number
    2025587-2018-03223
    Event Type
    Injury
    Date Received
    November 28, 2018
    Date of Event
    November 7, 2018
    Report Date
    August 20, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000017835
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THERE WAS NO PROBLEM ASSOCIATED WITH THE DEVICE NOT REMAINING IN AN EXPECTED LOCATION. THE VALVE DID NOT DEPLOY FROM THE DELIVERY CATHETER SYSTEM (DCS) AS EXPECTED (C133633); THE VALVE WAS DEPLOYED IN A LOCATION OTHER THAN WHAT WAS INITIALLY INTENDED (C63043). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B5. H6. CORRECTED DATA: B1. G1. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE VALVE LIKELY DISLODGED DUE TO A TAPERED LEFT VENTRICULAR OUTFLOW TRACT (LVOT) AND THE PATIENT¿S PRE-EXISTING AORTIC VALVE STENOSIS. AFTER THE VALVE WAS PULLED BACK INTO THE DISTAL ASCENDING AORTA, THE DCS WAS WITHDRAWN, AND A SECOND VALVE LOADED INTO THE DCS. THE DCS WAS ADVANCED OVER THE GUIDEWIRE WHICH REMAINED IN THE LEFT VENTRICLE. THE SECOND VALVE WAS ADVANCED THROUGH THE FIRST DISLODGED VALVE. THE VALVE WAS POSITIONED 5-6 MILLIMETER¿S (MM) ON THE NON-CORONARY CUSP (NCC), AND 3-4 MM ON THE LEFT CORONARY CUSP (LCC). A REPEAT TRANSTHORACIC ECHOCARDIOGRAM WAS PERFORMED THAT DEMONSTRATED GOOD POSITIONING OF THE VALVE. NO PARAVALVULAR LEAK (PVL), AND NO IMPINGEMENT ON THE ANTERIOR MITRAL VALVE LEAFLET WERE OBSERVED; THEREFORE, THE VALVE WAS DEPLOYED. SUBSEQUENTLY, AN ELLIPTICAL APPEARANCE OF THE VALVE WAS NOTED. REPEAT HEMODYNAMIC ASSESSMENT WAS PERFORMED THAT REVEALED A MEAN GRADIENT OF 19 MILLIMETERS OF MERCURY (MM HG) WITH AN END DIASTOLIC PRESSURE OF 24 MMHG. ADDITIONALLY, THE VALVE APPEARED TO BE UNDER-EXPANDED. PER THE PHYSICIAN, IT WAS LIKELY DUE TO BULKY CALCIFICATION OF THE PATIENT¿S NATIVE CUSPS, THE ELLIPTICAL ANNULUS, AND THE FUNCTIONALLY BICUSPID MORPHOLOGY OF THE NATIVE VALVE. A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED USING A 24 MM NON-MEDTRONIC BALLOON. THE BALLOON WAS INFLATED 2 TIMES WITH VISIBLE EXPANSION OF THE STENT FRAME. THE BAV WAS REMOVED AND REPEAT HEMODYNAMIC ASSESSMENT WAS PERFORMED THAT REVEALED A REDUCED MEAN GRADIENT OF 17 MMHG. THE VALVE WAS STILL UNDER-EXPANDED AND CONSTRAINED IN THE RIGHT ANTERIOR OBLIQUE VIEW, THEREFORE, THE POST-IMPLANT BAV WAS PERFORMED AGAIN USING A 26 MM NON-MEDTRONIC BALLOON. FULL EXPANSION OF THE BAV WAS NOTED, AND REPEAT TRANSTHORACIC ECHOCARDIOGRAPHY DEMONSTRATED NO PVL WITH GOOD POSITIONING OF THE VALVE. REPEAT HEMODYNAMIC ASSESSMENT WAS PERFORMED THAT REVEALED A MEAN GRADIENT OF 12 MMHG. ALL CATHETERS AND WIRES WERE WITHDRAWN. IT WAS NOTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS IN STABLE CONDITION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: E NVPRO-16-US, SERIAL/LOT #: (B)(4), UBD: 05-MAR-2020, UDI#: (B)(4). PRODUCT ANALYSIS: THE DELIVERY CATHETER SYSTEM (DCS) WAS DISCARDED BY THE CUSTOMER AND THE VALVE REMAINS IMPLANTED; THEREFORE, NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: WITHOUT RETURN OF THE PRODUCTS, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE DEPLOYMENT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, ONE OF THE PADDLES ON THE VALVE REMAINED ATTACHED TO THE DELIVERY CATHETER SYSTEM (DCS). IT WAS NOTED THAT ONLY ONE PADDLE WAS VISUALIZED, AND AS THE DCS WAS BEING WITHDRAWN, THE VALVE DISLODGED. THE VALVE WAS PULLED INTO THE ASCENDING AORTA AND DEPLOYED. SUBSEQUENTLY, A SECOND TRANSCATHETER BIOPROSTHETIC VALVE WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949143 EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTPRO-29-US 00763000017835

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention "SEE H10...."