BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MELODY TRANSCATHER PULMONARY

    MDR report key: 3833640 · Received May 27, 2014

    Report

    Report Number
    2025587-2014-00325
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 12, 2011
    Report Date
    July 25, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPV
    UDI-DI
    00613994663962
    PMA / PMN Number
    P140017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC¿S QUALITY LABORATORY, VISUAL EXAMINATION REVEALED AN UNKNOWN BARE METAL STENT REMAINED ATTACHED TO THE OUTER WALL OF THE VALVE. THE ANALYSIS OF THE DEVICE CONFIRMED PANNUS AND TAN VEGETATIVE HOST TISSUE THAT LINED THE INNER LUMEN ASPECT OF THE EXISTING MELODY VALVE. RADIOGRAPHY SHOWED NO EVIDENCE OF MINERALIZATION IN THE VALVE AND/OR HOST TISSUE. RADIOGRAPHY SHOWED BROKEN STRUTS HOWEVER THIS MAY HAVE OCCURRED DURING EXPLANT DUE TO THE LOCATION AND RECEIPT CONDITION OF THE VALVE. CONCLUSION: DOCUMENTS RECEIVED WITH THE RETURNED PRODUCT INDICATED THE VALVE WAS REPLACED DUE TO STENOSIS. BASED ON THE RECEIPT CONDITION OF THE DEVICE, A ROOT CAUSE FOR THE STENOSIS AND EXPLANT WAS NOT DETERMINED. HOWEVER, THE PRESENCE OF VEGETATION AND HOST TISSUE OVERGROWTH MAY BE A CONTRIBUTING FACTOR. THESE FINDINGS ARE GENERALLY CONSIDERED A PATIENT-RELATED CONDITION. THERE IS NO INDICATION OF ANY PRODUCT QUALITY ISSUES. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE VALVE REMAINS IMPLANTED. CONCLUSION: WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT RETROSPECTIVE REVIEW OF A CHEST X-RAY CONDUCTED ABOUT 1 YEAR POST-IMPLANT OF THIS TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV), A MINOR STENT FRACTURE WAS NOTED. A SECOND MINOR STENT FRACTURE WAS NOTED VIA CHEST X-RAY ON LATERAL PROJECTION 2 YEARS AND 7 MONTHS POST-IMPLANT. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED, AND NO TREATMENT WAS PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310320 MELODY TRANSCATHER PULMONARY PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI NPV MEDTRONIC HEART VALVES DIVISION PB1018 00613994663962

    Patients

    Seq Age Sex Outcome Treatment
    1 00014 YR Female Other| R