BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT PRO PLUS VALVE

    MDR report key: 20736254 · Received November 20, 2024

    Report

    Report Number
    2025587-2024-06689
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Date of Event
    November 12, 2024
    Report Date
    January 13, 2026
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: UPON RECEIPT OF THE SUSPECT COMPLAINT DEVICE AT MEDTRONIC¿S QUALITY LABORATORY, VISUAL ANALYSIS SHOWED THE DEVICE WAS RECEIVED IN ITS ORIGINAL PRODUCT PACKAGING. AMBER COLORED WATERMARKS SUGGESTED OF DRIED GLUTARALDEHYDE WERE OBSERVED ON THE INSIDE OF THE OUTER PACKAGING. THE TAMPER SAFETY SEAL ON THE RETURNED JAR WAS RECEIVED BROKEN. AMBER STAINS WERE NOTED ON THE OUTSIDE OF THE JAR LABEL. DUE TO THE RECEIPT CONDITION, A TORQUE ASSESSMENT TO EVALUATE AGAINST THE ¿DIFFICULT TO OPEN JAR¿ ALLEGATION COULD NOT BE PERFORMED. UPON OPENING THE JAR, REMNANTS OF GASKET MATERIAL WERE STUCK ALONG THE RIM OF THE JAR. CRYSTALLIZED, DRIED GLUTARALDEHYDE WAS NOTED ALONG THE SHOULDER AND THREADS OF THE JAR. SMALL WHITE PARTICULATES THAT APPEAR TO BE FROM THE GASKET WERE OBSERVED INSIDE THE JAR. THE GASKET SHOWED DEEP PITS IN THE RUBBER CONSISTENT WITH PIECES OF GASKET STUCK TO THE RIM OF THE JAR. AMBER STAINS SUGGESTIVE OF DRIED GLUTARALDEHYDE WERE FOUND ALONG THE THREADS OF THE LID. THE PARTICULATES WERE REMOVED AND SENT TO FOR ANALYSIS. THERE WAS A PEAK AT 1734CM-1 CONSISTENT WITH A CARBONYL AND PEAKS 1255CM-1 AND 1166CM-1 THAT WERE CONSISTENT WITH C-C STRETCHING. THE PARTICLES WERE SPECTROSCOPICALLY CONSISTENT WITH POLYDIMETHYLSILOXANE. THE 3M FREEZE WATCH TEMPERATURE INDICATOR WAS NOT ACTIVATED. THE MOLD CAVITY NUMBERS WERE JAR: 07 AND LID: 2. UPDATED H.6 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    UPDATED H.6. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 34 MM EVOLUT PRO+ VALVE JAR WAS DIFFICULT TO OPEN AND PARTICLES FROM THE SEALING RING DROPPED INTO THE JAR. THE HEALTHCARE PROFESSIONAL TRIED THREE MORE JARS CONTAINING VALVES OF THE SAME SIZE AND MODEL BUT ENCOUNTERED THE EXACT SAME ISSUES. COLLECTIVELY, THE FOUR VALVES WERE NOT USED. A FIFTH VALVE WAS OPENED AND USED FOR IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2000274 EVOLUT PRO PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVPROPLUS-34

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown