BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHER PULMONARY

    MDR report key: 3942002 · Received July 17, 2014

    Report

    Report Number
    2025587-2014-00486
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 21, 2014
    Report Date
    August 11, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPV
    PMA / PMN Number
    H080002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SEPARATE MEDWATCH REPORT HAS BEEN FILED FOR THE SECOND TPV. IT WAS REPORTED THE EXPLANTED DEVICES WOULD BE RETURNED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED OR IF THE DEVICES ARE RETURNED FOR ANALYSIS. (B)(4).

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. BASED ON THE INFORMATION AVAILABLE, PATIENT ANATOMY AND PHYSIOLOGY LIKELY CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. A SUPPLEMENTAL REPORT WILL BE FILED IF THE DEVICE IS RETURNED OR ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT NINE DAYS AFTER IMPLANT OF THIS TRANSCATHETER PULMONARY VALVE (TPV), IT WAS OBSERVED THAT THE TPV WAS APPROXIMATELY TWO-THIRDS STENOTIC AND THERE HAD BEEN AN INCREASE IN GRADIENT MEASUREMENTS. IT WAS NOTED THAT THERE WERE NO CHANGES TO POSITIONING OF THE VALVE AND STENT. SUBSEQUENTLY, A STENT WAS DEPLOYED AND A SECOND TPV OF THE SAME MODEL WAS IMPLANTED INTO THE FIRST TPV. THE PATIENT SUBSEQUENTLY PRESENTED TO THE HOSPITAL WITH HYPOXEMIA, CYANOSIS AND SHORTNESS OF BREATH. THE SECOND DEVICE ALSO WAS FOUND TO BE OBSTRUCTED, AND BOTH TPVS WERE EXPLANTED AND REPLACED WITH A VALVED CONDUIT TWELVE DAYS AFTER THE ORIGINAL REOPERATION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED. THE PHYSICIAN REPORTED THAT IT COULD NOT BE DETERMINED WHY THE OBSTRUCTIONS OCCURRED IN THE TWO DEVICES, BUT THAT THE PATIENT ANATOMY AND PHYSIOLOGY WERE THE UNDERLYING CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418649 MELODY TRANSCATHER PULMONARY PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV MEDTRONIC HEART VALVES DIVISION PB1018

    Patients

    Seq Age Sex Outcome Treatment
    1 00010 YR Required Intervention