BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 18310593 · Received December 12, 2023

    Report

    Report Number
    2025587-2023-05156
    Event Type
    Death
    Date Received
    December 12, 2023
    Date of Event
    November 4, 2023
    Report Date
    December 12, 2023
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: NHAN VT, KHOA NQ, THUY T, ET AL. EARLY SAFETY AND MID-TERM CLINICAL OUTCOMES OF TECHNOLOGY TRANSFER OF TRANSCATHETER AORTIC VALVE IMPLANTATION IN PATIENTS WITH SEVERE AORTIC VALVE STENOSIS IN VIETNAM: A SINGLE-CENTER EXPERIENCE OF 90 PATIENTS. LANCET REG HEALTH WEST PAC. 2023;42:100956. PUBLISHED 2023 NOV 4. DOI:10.1016/J.LANWPC.2023.100956 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT AND DATE OF DEATH. MEDTRONIC PRODUCTS REFERENCED: EVOLUT R (PRODUCT CODE NPT, PMA# P130021), EVOLUT PRO (PRODUCT CODE NPT, PMA# P130021). EARLIEST APP ROVED 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

    LITERATURE WAS REVIEWED REGARDING THE OUTCOMES OF STEPWISE IMPLEMENTATION OF TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) IN VIETNAMESE PATIENTS. MEDTRONIC EVOLUT R/PRO (N = 89) AND NON-MEDTRONIC (N = 3) TAVI SYSTEMS WERE USED IN THE STUDY. THE AUTHORS WROTE, ¿ONE PROCEDURAL DEATH OCCURRED IN A PATIENT WITH PELVIC AND AORTIC ROOT DISSECTION WHEN THE OPERATOR USED A SNARE TO PUSH THE 26 MMEVOLUT R VALVE THROUGH THE HORIZONTAL AORTA (AT AN ANGLE OF 66°).¿ AN ADDITIONAL THREE DEATHS WERE OBSERVED WITHIN ONE YEAR OF TAVI (ONE CARDIAC-RELATED, ONE WITH ACUTE HEART FAILURE, AND ONE SUDDEN DEATH AT HOME). OTHER ADVERSE OUTCOMES INCLUDED: STROKE/DISABLING STROKE; VALVE EMBOLIZATION CAUSING STROKE, AORTIC ROOT DISSECTION, AND NEED FOR EMERGENT VALVE REPLACEMENT SURGERY (EVOLUT R CASE); VALVE EMBOLIZATION WARRANTING THE USE OF A SNARE AND IMPLANT OF A SECOND VALVE RESULTING IN AORTIC ROOT DISSECTION (EVOLUT R CASE); CORONARY OCCLUSION FOLLOWING VALVE DEPLOYMENT AT A HIGH POSITION REQUIRING EMERGENT VALVE REPLACEMENT SURGERY (EVOLUT R CASE); CONVERSION TO OPEN HEART SURGERY; LIFE-THREATENING BLEEDING; MAJOR VASCULAR COMPLICATIONS; COMPLETE ATRIOVENTRICULAR BLOCK; NEW PERMANENT PACEMAKER IMPLANTATION; VALVE MALPOSITIONING; PARAVALVULAR LEAK (MODERATE OR SEVERE); TWO VALVES IMPLANTED; AND HOSPITAL READMISSION FOR WORSENING HEART FAILURE. NO FURTHER INFORMATION PERTAINING TO MEDTRONIC PRODUCTS WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214607 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Death