BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 16288161 · Received February 2, 2023

    Report

    Report Number
    2025587-2023-00386
    Event Type
    Injury
    Date Received
    February 2, 2023
    Date of Event
    December 27, 2022
    Report Date
    April 14, 2023
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION: NO VALVE IMPLANTATION PROCEDURE IMAGES WERE AVAILABLE FOR MEDTRONIC REVIEW, AND THE VALVE REMAINED IMPLANTED, SO NO PRODUCT ANALYSIS COULD BE PERFORMED. HIGH GRADIENTS CAN BE RELATED TO VALVE RELATED FACTORS (DEGENERATION, THROMBUS, CALCIFICATION, ETC) OR NON-VALVE RELATED FACTORS (LVOT OBSTRUCTION, PATIENT PRESSURES, LV DYSFUNCTION, ETC). CALCIFICATION IS A RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. MANY FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF CAL CIFICATION INCLUDING PATIENT RELATED (E.G. PATIENT AGE, DISEASE STAGE, IMMUNE STATUS, AND OTHER COMORBIDITIES), PHARMACOLOGICAL, AND INTRINSIC PROPERTIES OF THE VALVE ITSELF. STENOSIS IS A KNOWN POTENTIAL ADVERSE EFFECT PER THE DEVICE INSTRUCTIONS FOR USE (IFU). STENOSIS OF BIOPROSTHETIC VALVES CAN BE A MANIFESTATION OF STRUCTURAL VALVE DYSFUNCTION (E.G. CALCIFICATION), THROMBOSIS, AND/OR NONSTRUCTURAL DYSFUNCTION (E.G. PANNUS, OBSTRUCTION, ETC.). SEVERAL FACTORS CAN CONTRIBUTE TO THE ONSET AND PROPAGATION OF EITHER FAILURE MECHANISM SUCH AS PATIENT MEDICAL HISTORY (AGE, DISEASE STAGE, COMORBIDITIES, ETC.), PHARMACOLOGICAL FACTORS, AND/OR INTRINSIC PROPERTIES OF THE VALVE ITSELF. REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS DEVICE WAS PERFORMED. BASED ON THE DHR REVIEW, ALL PROCESS PARAMETERS WERE WITHIN SPECIFICATION AS OUTLINED IN APPLICABLE PROCEDURES AND SPECIFICATIONS. ALL MATERIALS USED WERE AS PER THE REQUIREMENTS OF THE DHR. ALL PROCESSES WERE CARRIED OUT AS PER RELEVANT PROCEDURES AND MET SPECIFICATION. THIS EVENT DOES NOT INDICATE DEVICE MISUSE OR MALF UNCTION. 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

    PRODUCT ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. 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 APPROXIMATELY FOUR YEARS AND ELEVEN MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, AN ECHOCARDIOGRAM WAS PERFORMED AND DETECTED A GRADIENT OF 100 MMHG. AS A RESULT, UNSPECIFIED SYMPTOMS RELATED TO AORTIC STENOSIS WERE REPORTED. IMAGING CONDUCTED NOTED THE VALVE LEAFLETS WERE CALCIFIED. THE PATIENT WAS PLANNED FOR SURGICAL REPLACEMENT OF THE VALVE, USING A NON-MEDTRONIC SURGICAL AORTIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347046 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-26

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening