BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVALUS AORTIC TISSUE VALVE

    MDR report key: 22579902 · Received July 23, 2025

    Report

    Report Number
    2025587-2025-05235
    Event Type
    Injury
    Date Received
    July 23, 2025
    Date of Event
    September 26, 2024
    Report Date
    July 23, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P170006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: 40027, (UNKNOWN SERIAL/LOT); PRODUCT TYPE: 0195-HEART VALVES; CITATION: AAKASH ANGIREKULA., ET AL.. SUCCESSFUL REDO SURGICAL REPLACEMENT OF A FLAIL BIOPROSTHETIC AORTIC VALVE: A CASE REPORT. AME RICAN JOURNAL OF CASE REPORTS 25: E945043 2024. 10.12659/AJCR.945043 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. 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. D6: IMPLANT DATE (YEAR VALID) 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 A 58 -YEAR-OLD MALE PATIENT WHO UNDERWENT SURGICAL AORTIC VALVE REPLACEMENTS WITH THE MEDTRONIC 25MM AVALUS BIOPROSTHETIC VALVE. IT WAS REPORTED THAT POST IMPLANT, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH SEVERE CHEST PAIN AND SHORTNESS OF BREATH. THE PATIENT WAS FOUND TO BE HYPOTENSIVE AND IN CARDIOGENIC SHOCK, REQUIRING MULTIPLE VASOPRESSORS. AN ELECTROCARDIOGRAM (ECG) PERFORMED REVEALED SINUS TACHYCARDIA WITH FIRST-DEGREE ATRIOVENTRICULAR (AV) BLOCK AT 106 BPM, RIGHT BUNDLE BRANCH BLOCK, AND LEFT ANTERIOR FASCICULAR BLOCK. A CHEST X-RAY SHOWED SIGNIFICANT PULMONARY VASCULAR AND INTERSTITIAL CONGESTION, AND CARDIAC CATHETER­IZATION DISPLAYED NONOBSTRUCTIVE CORONARY ARTERY DISEASE. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PERFORMED NOTED SE­VERE AORTIC REGURGITATION AND AN INTRAOPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED EVIDENCE OF PROSTHETIC VALVE FAILURE WITH COMPLETE PROLAPSE OF THE NONCORONARY CUSP. IT WAS REPORTED THAT THE PROSTHETIC AORTIC VALVE¿S NONCORONARY CUSP LEAFLET WAS FOUND FLAILING INTO THE LEFT VEN­TRICULAR OUTFLOW TRACT, WHILE THE OTHER 2 LEAFLETS SEEMED NORMAL. THE VALVE WAS EXPLANTED AND REPLACED WITH A MEDTRONIC 27MM AVALUS BIOPROSTHETIC VALVE. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO THE MEDTRONIC PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46997 AVALUS AORTIC TISSUE VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 40025

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention| L| H