BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT FX VALVE

    MDR report key: 20534223 · Received October 25, 2024

    Report

    Report Number
    2025587-2024-06025
    Event Type
    Death
    Date Received
    October 25, 2024
    Date of Event
    October 17, 2024
    Report Date
    May 22, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONTINUED: MODEL NUMBER: GWC-12325LG-FT; CATALOG NUMBER: 7-10038-05; UDI: (B)(4); LOT NUMBER: 534624-3; MANUFACTURE DATE: 5/1/2024. THE DEVICE HISTORY RECORD FOR THIS OAD LOT NUMBER HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE MET MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE REPORTED DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE MATERIAL INSPECTION REVIEW FOR THIS GUIDE WIRE LOT NUMBER HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE MET MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE REPORTED DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. CSI ID: (B)(4).

    Additional Manufacturer Narrative · 0

    UPDATED: B1, B2, B5, E1, H6. 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

    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

    MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED DUE TO AN UNKNOWN REASON. SUBSEQUENTLY, ATRIO-VENTRICULAR (AV) BLOCK WAS OBSERVED. A TEMPORARY PACEMAKER WAS PLACED BEFORE EXITING THE OPERATING ROOM. THE PATIENT WAS PLACED UNDER OBSERVATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED DUE TO AN UNKNOWN REASON. SUBSEQUENTLY, ATRIO-VENTRICULAR (AV) BLOCK WAS OBSERVED. A TEMPORARY PACEMAKER WAS PLACED BEFORE EXITING THE OPERATING ROOM. THE PATIENT WAS PLACED UNDER OBSERVATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE POST-IMPLANT BAV WAS PERFORMED DUE TO UNDER-EXPANSION OF THE VALVE FRAME. ADDITIONAL INFORMATION WAS RECEIVED THAT TWO DAYS FOLLOWING THE VALVE IMPLANT, THE PATIENT DIED DUE TO BLEEDING FROM A RUPTURE OF AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN DID NOT ATTRIBUTE THE RUPTURE AND SUBSEQUENT DEATH TO THE DEVICE OR THE IMPLANT PROCEDURE, BUT THE CAUSE WAS NOT REPORTED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A POST-IMPLANT BALLOON AORTIC V ALVULOPLASTY (BAV) WAS PERFORMED DUE TO AN UNKNOWN REASON. SUBSEQUENTLY, ATRIO-VENTRICULAR (AV) BLOCK WAS OBSERVED. A TEMPORARY PACEMAKER WAS PLACED BEFORE EXITING THE OPERATING ROOM. THE PATIENT WAS PLACED UNDER OBSERVATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE POST-IMPLANT BAV WAS PERFORMED DUE TO UNDER-EXPANSION OF THE VALVE FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795763 EVOLUT FX VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTFX-34

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| R SEE H11...