BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHER PULMONARY

    MDR report key: 3123478 · Received May 22, 2013

    Report

    Report Number
    2025587-2013-00080
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    April 22, 2013
    Report Date
    May 23, 2013
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    NPV
    PMA / PMN Number
    H080002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING THE SUBMISSION OF THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE ECHOCARDIOGRAM FINDINGS REPORTED PREVIOUSLY WERE INCORRECT. THE CORRECTED EVENT DESCRIPTION IS AS FOLLOWS. MEDTRONIC RECEIVED INFORMATION THAT TWO YEARS AND SEVEN MONTHS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE WITHIN A RV-PA 18MM BIOPROSTHETIC CONDUIT, ECHOCARDIOGRAPHY REVEALED MARKED PROXIMAL NARROWING OF THE CONDUIT WITH A PEAK GRADIENT OF 72 MMHG (MEAN GRADIENT 43MMHG) WITH RV PRESSURE ESTIMATED TO BE >100 MMHG. THE PATIENT EXPERIENCED PROGRESSIVE WORSENING OF RIGHT VENTRICULAR SYSTOLIC PRESSURES AND WORSENING PULMONARY INSUFFICIENCY IN THE SETTING OF WORSENING FATIGUE AND EXERCISE CAPABILITIES. FOUR MONTHS LATER, ECHOCARDIOGRAM SHOWED A PEAK GRADIENT OF 54 MMHG (MEAN GRADIENT 33 MMHG) AND LIKELY MODERATE PULMONARY INSUFFICIENCY WITH AN RV PRESSURE OF APPROXIMATELY 80 MMHG. IT WAS REPORTED THAT THE STENOSIS WAS DUE TO THE PATIENT OUTGROWING THE SIZE OF THE CONDUIT (THE PATIENT WAS 12 YEARS OLD AT THE TIME THE VALVE WAS IMPLANTED WITHIN THE CONDUIT) AND THE REGURGITATION WAS DUE TO DYSFUNCTION OF THE TRANSCATHETER BIOPROSTHETIC VALVE. THE TRANSCATHETER BIOPROSTHETIC VALVE COULD NOT BE MADE LARGER AS THE CONDUIT HAD A FIXED RING. THE INNER DIAMETER OF THE 18MM CONDUIT WAS APPROXIMATELY 16MM. SUBSEQUENTLY, THE CONDUIT AND TRANSCATHETER BIOPROSTHETIC VALVE WERE EXPLANTED AND REPLACED WITH A RV-PA 25MM BIOPROSTHETIC CONDUIT. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, THE VALVE WAS RECEIVED DEPLOYED WITHIN A 5.7 CM SECTION OF THE CONDUIT. ALL LEAFLETS APPEARED SLIGHTLY STIFF BUT FLEXIBLE EXCEPT WHERE VISIBLE MINERALIZATION WAS PRESENT. TISSUE DETERIORATION DUE TO MINERALIZATION WAS OBSERVED ON ALL LEAFLETS. ONE COMMISSURE APPEARED INTACT. TISSUE DETERIORATION DUE TO MINERALIZATION WAS OBSERVED ON THE OTHER TWO COMMISSURES. GLISTENING OFF-WHITE PANNUS APPEARED TO LINE THE OUTFLOW ORIFICE EXTENDING APPROXIMATELY 1 TO 6 MM INTO THE INNER LUMEN. RADIOGRAPHY SHOWED MINERALIZATION ALONG THE CONDUIT WALL AND LEAFLETS OF THE MELODY. RADIOGRAPHY APPEARED TO SHOW NO EVIDENCE OF FRACTURES TO THE STENT AND REINFORCING BAND. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. REDUCED PERFORMANCE OF THE VALVE IS ATTRIBUTED TO HOST TISSUE OVERGROWTH AND MINERALIZATION. THESE FINDINGS ARE GENERALLY CONSIDERED PATIENT RELATED CONDITIONS. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THREE YEARS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE WITHIN A RV-PA 18MM BIOPROSTHETIC CONDUIT, THE PATIENT EXPERIENCED PROGRESSIVE WORSENING OF RIGHT VENTRICULAR SYSTOLIC PRESSURES AND WORSENING PULMONARY INSUFFICIENCY IN THE SETTING OF WORSENING FATIGUE AND EXERCISE CAPABILITIES. ECHOCARDIOGRAPHY REVEALED STENOSIS (PEAK GRADIENT 20 MMHG) AND CENTRAL REGURGITATION. IT WAS REPORTED THAT THE STENOSIS WAS DUE TO THE PATIENT OUTGROWING THE SIZE OF THE CONDUIT (THE PATIENT WAS (B)(6) AT THE TIME THE VALVE WAS IMPLANTED WITHIN THE CONDUIT). THE TRANSCATHETER BIOPROSTHETIC VALVE COULD NOT BE MADE LARGER AS THE CONDUIT HAD A FIXED RING. THE INNER DIAMETER OF THE 18MM CONDUIT WAS APPROXIMATELY 16MM. IT WAS REPORTED THAT THE REGURGITATION WAS DUE TO DYSFUNCTION OF THE TRANSCATHETER BIOPROSTHETIC VALVE. THE CONDUIT AND TRANSCATHETER BIOPROSTHETIC VALVE WERE EXPLANTED AND REPLACED WITH A RV-PA 25MM BIOPROSTHETIC CONDUIT. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225802 MELODY TRANSCATHER PULMONARY PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV HEART VALVES SANTA ANA PB1018

    Patients

    Seq Age Sex Outcome Treatment
    1 00015 YR Required Intervention