BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 3180696 · Received June 20, 2013

    Report

    Report Number
    2025587-2013-00099
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC¿S QUALITY LABORATORY, THE VALVE WAS RECEIVED IN A CLEAR SOLUTION IN THE ORIGINAL PRODUCT JAR PLACED IN AN EXPLANT KIT. THE VALVE WAS DISCOLORED SHOWING EVIDENCE OF BLOOD CONTACT. ALL LEAFLETS WERE IN A SEMI - RELAXED POSITION WHICH IS A NORMAL FINDING FOR THIS VALVE AS IT IS PROCESSED WITH THE LEAFLETS IN A RELAXED STATE. ALL LEAFLETS WERE SLIGHTLY STIFF BUT FLEXIBLE POSSIBLY DUE TO BLOOD CONTACT AND/OR THE DECONTAMINATION PROCESS. ALL LEAFLETS AND COMMISSURES WERE INTACT. THE VALVE WAS TESTED IN-HOUSE ON THE PULSE DUPLICATOR AT 70 BEATS PER MINUTE/65% DIASTOLE; C.O. OF 5 L/M. THE HYDRODYNAMIC TESTING DATA SHOWED THE GRADIENTS WERE SMALLER THAN THE HISTORICAL TESTING DATA. THE REGURGITATIONS WERE LESS THAN THE REGURGITATION BASELINE, AS WELL. HIGH SPEED VIDEO REVIEW SHOWED THE REGURGITANT VALUES WERE VERY LOW AND CONSISTENT WITH EXPECTATION. THE OPENING AND CLOSING BEHAVIOR APPEARED NORMAL. THERE WAS NO EVIDENCE OF LEAKAGE (GAPS, HOLES, ETC¿BETWEEN LEAFLETS) WHEN THE LEAFLETS WERE CLOSED. NOTE: VIDEO WAS REVIEWED UNDER STANDARD SETTINGS OF 1000 FRAMES PER SECOND. CONCLUSION: THE DEVICE HISTORY REVIEW OF THIS VALVE WAS REVIEWED AND NO ISSUES WERE NOTED THAT WOULD HAVE IMPACTED THIS EVENT. THE GROSS ANALYSIS OF THE VALVE DID NOT NOTE ANY ANOMALIES THAT WOULD HAVE CAUSED THE REPORTED REGURGITATION. HIGH SPEED VIDEO SHOWED THAT THE VALVE FUNCTIONED WELL WITH GOOD OPENING OF ALL THREE LEAFLETS AND SYNCHRONOUS CLOSURE. COAPTATION WAS DEEP AND TIGHT (NO AREAS OF GAPPING OR SIGNS OF LEAKAGE). BASED ON THE ANALYSIS THIS VALVE PERFORMED AS INTENDED. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE, IMPLANTED 4 HOURS, WAS EXPLANTED DUE TO AORTIC STENOSIS AND INSUFFICIENCY OBSERVED ON INTRA-OPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAM. THE STUDY SHOWED MODERATE TO SEVERE AORTIC VALVE REGURGITATION. LEFT VENTRICULAR SYSTOLIC FUNCTION WAS NORMAL. LEFT VENTRICULAR EJECTION FRACTION WAS ESTIMATED TO BE 60-65%. MILD ATHEROSCLEROTIC CHANGES WERE SEEN IN THE DESCENDING THORACIC AORTA. THE 27MM BIOPROSTHETIC AORTIC VALVE APPEARED WELL-SEATED AND WAS FUNCTIONING NORMALLY, HOWEVER, COLOR FLOW DOPPLER DEMONSTRATED MODERATE TO SEVERE AORTIC INSUFFICIENCY. THE VALVE WAS EXPLANTED AND A SECOND BIPROSTHETIC AORTIC VALVE WAS PLACED. THE VALVE APPEARED TO BE WELL SEATED AND WAS FUNCTIONING NORMALLY. THERE WAS NO AORTIC INSUFFICIENCY SEEN. PATIENT WAS (B)(6). THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE EXPLANTED VALVE WAS RETURNED FOR LABORATORY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280789 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR HEART VALVES SANTA ANA 305

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention