BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVALUS AORTIC TISSUE VALVE

    MDR report key: 23658317 · Received November 26, 2025

    Report

    Report Number
    9617601-2025-03041
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    November 24, 2025
    Report Date
    March 9, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    LWR
    UDI-DI
    00643169983250
    PMA / PMN Number
    P170006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, VISUAL EXAMINATION REVEALED THAT THE VALVE APPEARED DISCOLORED, SHOWING EVIDENCE OF BLOOD CONTACT. ALL LEAFLETS WERE IN A SEMI-CLOSED CONFIGURATION, WITH A DISCERNABLE COAPTIVE GAP BETWEEN LEAFLET 3 AND LEAFLETS 1 AND 2. ALL LEAFLETS APPEARED STRUCTURALLY INTACT. SMALL FOLDS WERE OBSERVED ALONG THE MARGIN OF ATTACHMENT (MOA) OF L2. A SMALL GAP WAS OBSERVED AT THE INFERIOR COAPTIVE JUNCTION (ICJ) OF COMMISSURE 4, DISTAL TO POST 3. SIMILAR SMALL FOLDS WERE NOTED ALONG THE MOA OF LEAFLET 3. A COMPARABLE GAP WAS PRESENT AT THE ICJ OF COMMISSURE 6, DISTAL TO POST 1. ALL COMMISSURES APPEARED INTACT. POSTS 1 AND 2 EXHIBITED A VISIBLE LATERAL AND INWARD DEFLECTION. POST 3 EXHIBITED AN INWARD DEFLECTION. UPON RECEIPT, THE VALVE'S SEWING CUFF WAS ORIENTED IN AN UPRIGHT POSITION. D9: UPDATED H3: DEVICE EVALUATED? UPDATED H6: UPDATED THE CODES 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.

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B.5: EVENT DESCRIPTION. 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 DURING THE IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTURERS PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS SEVERE CENTRAL AORTIC REGURGITATION JET. IT WAS FURTHER NOTED THAT UPON EXPLANT, A SIGNIFICANT CENTRAL GAP WAS NOTED IN THE VALVE, AS ONE LEAFLET APPEARED SMALLER THAN THE OTHERS. THE REGURGITATION WAS ORIGINATING FROM THE MID VALVE REGION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE DEVICE WAS NOT INSPECTED PRIOR TO USE. IT WAS FURTHER NOTED THAT AVALUS SIZERS WERE USED DURING THE IMPLANT PROCEDURE, AS WELL AS THE BARREL END OF THE SIZER. A BODY SURFACE AREA (BSA) CHART WAS NOT USED DURING IMPLANT, AND THE PATIENT DID NOT HAVE ANY UNIQUE ANATOMICAL FACTORS THAT CONTRIBUTED TO THE EVENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2620404 AVALUS AORTIC TISSUE VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC MEXICO S. DE R.L. DE CV 40021 00643169983250

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention| L