BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER DELIVERY SYSTEM

    MDR report key: 20797396 · Received November 27, 2024

    Report

    Report Number
    2025587-2024-06876
    Event Type
    Injury
    Date Received
    November 27, 2024
    Date of Event
    October 9, 2024
    Report Date
    November 27, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: NAKASE M, TOMII D, SAMIM D, ET AL. IMPACT OF SEVERITY AND EXTENT OF ILIOFEMORAL ATHEROSCLEROSIS ON CLINICAL OUTCOMES IN PATIENTS UNDERGOING TAVR. JACC CARDIOVASC INTERV. 2024;17(20):2353-2363. DOI:10.1016/J.JCIN.2024.07.009 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED IN THE ARTICLE: EVOLUT R (PRODUCT CODE NPT, PMA# P130021), EVOLUT PRO (PRODUCT CODE NPT, PMA# P130021), AND 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 SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE IMPACT OF ILIOFEMORAL ATHEROSCLEROSIS ON OUTCOMES IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THE STUDY POPULATION CONSISTED OF 2,023 PATIENTS WHO UNDERWENT TRANSFEMORAL TAVR WITH EITHER A MEDTRONICVALVE SYSTEM (EVOLUT R/PRO/PRO+) OR A NON-MEDTRONIC VALVE SYSTEM (VARIOUS BRANDS). WITHIN ONE YEAR OF TAVR, A TOTAL OF 308 DEATHS OCCURRED. THERE WAS NO EVIDENCE PRESENTED TO SUGGEST A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. OTHER ADVERSE OUTCOMES OBSERVED FOLLOWING TAVR: STROKE AND VASCULAR COMPLICATIONS. VASCULAR COMPLICATIONS ENCOMPASSED PUNCTURE SITE AND NON-PUNCTURE SITE PERFORATION, RUPTURE, DISSECTION, STENOSIS/OCCLUSION, PSEUDOANEURYSM, AND HEMATOMA. TO TREAT THESE COMPLICATIONS, THE AUTHORS PERFORMED COVERED OR UNCOVERED STENT PLACEMENT, BALLOON ANGIOPLASTY, OR SURGERY. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2367378 MEDTRONIC TRANSCATHETER DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS DCS

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention| L