BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 18730499 · Received February 19, 2024

    Report

    Report Number
    2025587-2024-00968
    Event Type
    Malfunction
    Date Received
    February 19, 2024
    Date of Event
    April 11, 2019
    Report Date
    February 29, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000017835
    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

    B3: DATE IS APPROXIMATE. MONTH AND YEAR ARE CONFIRMED VALID. 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

    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, DIRECT ARTERIAL CUTDOWN ACCESS WAS PERFORMED TO THE LEFT COMMON FEMORAL ARTERY (CFA) AND A 5FR SHEATH WAS PLACED. PERCUTANEOUS ACCESS WAS COMPLETED BY THE IMPLANTING PHYSICIAN TO THE RIGHT CFA. ANGIOGRAPHY OF THE RIGHT CFA ACCESS SITE SHOWED THAT THE SHEATH WAS IN THE MIDPORTION OF THE CFA. MODERATE-SEVERE CALCIFICATION WITH MODERATE STENOSIS OF THE RIGHT CFA WERE NOTED. AT THIS POINT, THE SHORT 6FR SHEATH WAS EXCHANGED FROM THE RIGHT CFA AND REPLACED BY 6FR DESTINATION SHEATH TO THE RIGHT CFA, WHICH WAS POSITIONED IN THE PROXIMAL PORTION OF THE DESCENDING THORACIC AORTA. A 5FR PIGTAIL CATHETER WAS ADVANCED VIA THE DESTINATION SHEATH AND PLACED IN THE NON-CORONARY CUSP OF THE AORTIC VALVE. AT THIS POINT, ARTERIAL ACCESS WAS OBTAINED BY THE IMPLANTING PHYSICIAN TO THE LEFT CFA. A 6FR SHEATH WAS PLACED. INTRAVENOUS HEPARIN WAS ADMINISTERED. VIA THE LEFT CFA ACCESS SITE, AL1 DIAGNOSTIC CATHETER WAS ADVANCED TO THE AORTIC ROOT. WITH THE USE OF A STRAIGHT 0.035-INCH GUIDEWIRE, THE AORTIC VALVE WAS CROSSED. THE AL1 CATHETER WAS POSITIONED IN THE LEFT VENTRICLE AND EXCHANGED FOR A PIGTAIL CATHETER. SIMULTANEOUS LEFT VENTRICULAR (LV) AND AORTIC PRESSURE MEASUREMENTS WERE OBTAINED. THE MEAN GRADIENT WAS 38.1M MHG. THE END DIASTOLIC PRESSURES WERE SEPARATED BY APPROXIMATELY 40MMHG. AT THIS POINT, THE PIGTAIL CATHETER WAS REMOVED AND EXCHANGED FOR A 0.035-INCH MEDTRONIC CONFIDA GUIDEWIRE IN THE LV. THE VALVE WAS LOADED AND INSPECTED UNDER FLUOROSCOPY AND APPEARED TO BE LOADED PROPERLY. AT THIS POINT, THE 6FR SHEATH WAS REMOVED FROM THE LEFT CFA AND THE IN-LINE DELIVERY SHEATH WAS ADVANCED WITH THE TRANSCATHETER AORTIC VALVE TO THE LEFT CFA EASILY. THE TRANSCATHETER AORTIC VALVE WAS THEN ADVANCED ACROSS THE AORTIC VALVE AND POSITIONED BY AORTIC ROOT ANGIOGRAM. THE PATIENT WAS PACED AT APPROXIMATELY 100 BEATS PER MINUTE. DURING PACING, THE VALVE WAS PARTIALLY DEPLOYED. THE VALVE APPEARED TO BE IN VERY STABLE POSITION BOTH BY FLUOROSCOPY AND TRANSESOPHAGEAL ECHOCARDIOGRAM. THE VALVE WAS THEN FULLY DEPLOYED AND REMAINED IN STABLE POSITION. BY FLUOROSCOPY, IT APPEARED THAT THE VALVE WAS UNDER DEPLOYED AND CONSTRAINED AT THE LOWER PORTION OF THE VALVE. MILD-MODERATE AORTIC INSUFFICIENCY (AI) WAS OBSERVED. THEREFORE, POST-DILATATION WAS PERFORMED UNDER RAPID RIGHT VENTRICULAR PACING WITH A 23MM NON-MEDTRONIC BALLOON. FOLLOWING POST-DILATATION, MILD-MODERATE AI WAS NOTED. THE LEFT VENTRICULAR AND AORTIC END DIASTOLIC PRESSURE WERE SOMEWHAT NARROWED COMPARED TO THE PREPROCEDURAL VALUES. THEREFORE, A REPEAT POST-DILATATION WAS PERFORMED WITH A 25MM NON-MEDTRONIC BALLOON UNDER RAPID VENTRICULAR PACING. FOLLOWING USE OF A 25MM NON-MEDTRONIC BALLOON, THERE APPEARED TO BE RESIDUAL MILD-MODERATE PERIVALVULAR LEAK. IT APPEARED TO BE MORE MILD THAN MODERATE. REPEAT LEFT VENTRICULAR AND AORTIC PRESSURE MEASUREMENT SHOWED DIASTOLIC SEPARATION OF APPROXIMATELY 30MMHG, WHICH APPEAR TO BE IMPROVING GRADUALLY. THE PATIENT¿S BLOOD PRESSURE, HEART RATE, AND TELEMETRY WERE STABLE. AT THIS POINT, THE DESTINATION SHEATH WAS REMOVED FROM THE RIGHT CFA AND EXCHANGED FOR A 7FR SHORT SHEATH. THE LEFT GROIN ACCESS SITE WAS SUTURED CLOSED BY THE IMPLANTING PHYSICIAN. THE PATIENT WAS THEN TRANSPORTED BACK TO THE CARDIOVASCULAR INTENSIVE CARE UNIT AFTER EXTUBATION IN HEMODYNAMICALLY STABLE CONDITION. THERE WERE NO APPARENT ACUTE COMPLICATIONS. A PLANNED TEMPORARY PACEMAKER TO BE PLACED OVERNIGHT AND ONE UNIT OF PLATELET TO BE TRANSFUSED DUE TO THE PATIENT¿S MODERATE THROMBOCYTOPENIA WERE REPORTED. FOUR YEARS AND TEN MONTHS POST-IMPLANT, THE VALVE WAS FAILING DUE TO HIGH AND ELEVATED AORTIC GRADIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE MEAN GRADIENT AFTER THE VALVE WAS IMPLANTED WAS 3 MILLIMETERS OF MERCURY (MM HG). THE PATIENT HAD CALCIFIED ANATOMY THAT CONTRIBUTED TO THE ELEVATED GRADIENTS. THERE WAS NO THROMBUS OR LEAFLET THICKENING ON THE VALVE, AND THE VALVE WAS IMPLANTED INSIDE THE PATIENT¿S NATIVE ANNULUS. NO TREATMENT WAS PROVIDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503225 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 79 YR Male