BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 15514107 · Received September 30, 2022

    Report

    Report Number
    2025587-2022-02690
    Event Type
    Injury
    Date Received
    September 30, 2022
    Date of Event
    August 24, 2022
    Report Date
    September 29, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: TOMITA S.; ET AL. A CASE OF ASCENDING AORTIC REPLACEMENT AND AORTIC VALVE REPLACEMENT IN A PATIENT WITH GIANT PSEUDOANEURYSM OF THE ASCENDING AORTA DUE TO PROSTHETIC VALVE ENDOCARDITIS AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT USING EVOLUT PRO. ANN THORAC CARDIOVASC SURG. 2022 AUG 24. DOI: 10.5761/ATCS.CR.22-00089. PMID: 36002292. ONLINE AHEAD OF PRINT. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: EVOLUT PRO (PMA# P130021, PRODUCT CODE: NPT). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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 VIA LITERATURE REGARDING AN 82-YEAR-OLD MALE PATIENT WITH SEVERE AORTIC STENOSIS WHO UNDERWENT IMPLANT OF A 34-MM MEDTRONIC EVOLUT PRO BIOPROSTHETIC VALVE (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). APPROXIMATELY, 21 MONTHS LATER THE PATIENT WAS HOSPITALIZED WITH FEVER AND BLOOD CULTURES WERE POSITIVE FOR BACTERIA. DESPITE ANTIBIOTIC TREATMENT, THE PATIENT UNDERWENT MULTIPLE HOSPITALIZATIONS FOR RECURRENT FEVER OF UNKNOWN ORIGIN OVER A YEAR. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) REVEALED EVOLUT PRO LEAFLET THICKENING AND A MOVABLE VEGETATIVE LESION ON THE VALVE STENT. CONTRAST-ENHANCED CARDIAC COMPUTED TOMOGRAPHY (CT) SHOWED A SACCULAR AORTIC ANEURYSM NEAR THE SUPERIOR BORDER OF THE VALVE STENT. DURING SURGERY, EVIDENCE OF ENDOCARDITIS AND THE ANEURYSM WERE REVEALED. THE AORTIC INTIMA HAD REGENERATED/GROWN INTO THE EVOLUT PRO STENT AND THE LEFT VENTRICULAR OUTFLOW TRACT WAS COVERED IN VEGETATION. THE VALVE REQUIRED EXTENSIVE DISSECTION TO EXPLANT IT. SURGICAL AORTIC VALVE REPLACEMENT WAS THEN PERFORMED USING A 23-MM MEDTRONIC SURGICAL BIOPROSTHETIC VALVE CONCOMITANTLY WITH ASCENDING AORTIC REPLACEMENT WITH A NON-MEDTRONIC SYNTHETIC GRAFT. POST-OPERATIVE PATHOLOGICAL EXAMINATION OF THE EXPLANTED EVOLUT PRO SHOWED STRUCTURAL DEGENERATION, CALCIFICATION, AND FIBROUS CONNECTIVE TISSUE INFILTRATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1583878 EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTPRO-23

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Hospitalization| R| L