BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 18369892 · Received December 20, 2023

    Report

    Report Number
    2025587-2023-05350
    Event Type
    Injury
    Date Received
    December 20, 2023
    Date of Event
    May 25, 2023
    Report Date
    December 20, 2023
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SYSTEM REPORT. THE SECTION D INFORMATION IS FOR THE PRIMARY DEVICE, WHICH WAS IN USE WITH THE FOLLOWING: MEDTRONIC TRANSCATHETER DELIVERY SYSTEM, PRODUCT ID: MDT-TRANS DCS, LOT NUMBER(S): UNKNOWN. CITATION: SENGUTTUVAN NB, BHATT H, BALAKRISHNAN VK, ET AL. THE SAFETY AND EFFICACY OF BALLOON-EXPANDABLE VERSUS SELF-EXPANDING TRANS-CATHETER AORTIC VALVE REPLACEMENT IN HIGH-RISK PATIENTS WITH SEVERE SYMPTOMATIC AORTIC STENOSIS [PUBLISHED CORRECTION APPEARS IN FRONT CARDIOVASC MED. 2023 OCT 13;10:1282812]. FRONT CARDIOVASC MED. 2023;10:1130354. PUBLISHED 2023 MAY 25. DOI:10.3389/FCVM.2023.1130354 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: COREVALVE (PRODUCT CODE NPT, PMA# P130021), EVOLUT R (PRODUCT CODE NPT, PMA# P130021), EVOLUT PRO (PRODUCT CODE NPT, PMA# P130021). 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. 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

    LITERATURE WAS REVIEWED REGARDING A META-ANALYSIS OF BALLOON-EXPANDABLE VERSUS SELF-EXPANDING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PLATFORMS. MEDTRONIC (COREVALVE, EVOLUT R/PRO) AND NON-MEDTRONIC (VARIOUS) TRANSCATHETER VALVE TYPES WERE INCLUDED IN THE ANALYSIS. THE AUTHORS EXTRACTED, POOLED, AND EXAMINED OUTCOME DATA FROM SIX STUDIES. OUT OF 2,935 PATIENTS, 99 ALL-CAUSE DEATHS HAD OCCURRED WITHIN 30 DAYS OF TAVR. NO EVIDENCE WAS PRESENTED TO SUGGEST THAT A MEDTRONIC VALVE OR ITS FUNCTION CONTRIBUTED TO ANY OF THE DEATHS. THE AUTHORS ALSO ANALYZED THE FOLLOWING ADVERSE OUTCOMES: STROKE (DISABLING OR NON-DISABLING), BLEEDING (LIFE-THREATENING OR MAJOR), MAJOR VASCULAR COMPLICATIONS, ACUTE KIDNEY INJURY, MYOCARDIAL INFARCTION, VALVE-RELATED DYSFUNCTION REQUIRING REPEAT PROCEDURE, AORTIC REGURGITATION/PARAVALVULAR LEAK (MODERATE TO SEVERE), ATRIAL FIBRILLATION, REHOSPITALIZATION FOR VALVE-RELATED SYMPTOMS OR WORSENING CONGESTIVE HEART FAILURE, NEED FOR PERMANENT PACEMAKER IMPLANTATION, IMPLANT OF MORE THAN ONE VALVE DURING TAVR PROCEDURE, AND VALVE MALPOSITION. NO ADDITIONAL ADVERSE EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289484 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

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