BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 23137164 · Received September 24, 2025

    Report

    Report Number
    2025587-2025-05724
    Event Type
    Injury
    Date Received
    September 24, 2025
    Date of Event
    September 4, 2025
    Report Date
    December 18, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, VISUAL EXAMINATION REVEALED MINIMAL DEFLECTION WAS OBSERVED ON THE RIGHT-NONCORONARY AND LEFT-NONCORONARY STENT POSTS. NO DEFLECTION WAS NOTED ON THE LEFT NON-CORONARY STENT POST. THE OVERALL STENT STRUCTURE SHOWED NO DISTORTION. ALL LEAFLETS WERE IN A SEMI-RELAXED POSITION WHICH IS STANDARD FOR THE MOSAIC VALVE AS IT IS PROCESSED WITH LEAFLETS IN A RELAXED STATE. ALL LEAFLETS APPEARED TAN AND FLEXIBLE. THE RIGHT CUSP (RC) APPEARED PREDOMINANTLY INTACT, WITH A VERTICAL FLAP TEAR LOCATED AT THE AT THE MARGIN OF ATTACHMENT DISTAL TO THE RIGHT NON-CORONARY COMMISSURE. THE LEFT CUSP (LC) APPEARED INTACT WITH NO VISIBLE DAMAGE. THE NON-CORONARY CUSP (NC) EXHIBITED A HORIZONTAL TEAR (INCISION) ALONG THE BELLY, APPROXIMATELY 15 MM IN LENGTH. A LARGE INTRACUSPAL HEMATOMA WAS OBSERVED AT THE INFLOW. THE EDGES ALONG THE TEAR APPEARED CLEAN AND LINEAR, CONSISTENT WITH AN INCISION MADE BY A SHARP INSTRUMENT. THE LEFT RIGHT AND LEFT NON-CORONARY COMMISSURES APPEARED INTACT. THE SUPERIOR COAPTIVE AREA OF THE RIGHT NON-CORONARY COMMISSURE WAS INTACT, WITH THE PREVIOUSLY NOTED FLAP TEAR VISIBLE AT THE MARGIN OF ATTACHMENT. NO EVIDENCE OF HOST TISSUE GROWTH WAS OBSERVED ON THE RETURNED VALVE. THE SEWING RING WAS BLOOD-STAINED AND LARGELY INTACT, WITH ONLY MARGINAL TEARS NOTED. THE SERIAL NUMBER ON THE STENT POSTS WAS VERIFIED AS K015449. UPDATED DATA: D.9: DEVICE AVAILABLE FOR EVALUATION? H.2: IF FOLLOW-UP, WHAT TYPE? H.3: DEVICE EVALUATED? H.6: CODING 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 DURING THE IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS SEVERE AORTIC REGURGITATION. THE PATIENT WAS PLACED BACK ON BYPASS, AND WHEN REPLACING THE VALVE ONCE AGAIN, THE SURGEON FOUND A 1CM TEAR IN THE LEAFLET OF THE VALVE. ADDITIONAL TIME WAS SPENT ON CROSS CLAMP AND PROLONGED THE PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2384407 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION 305C227

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R