BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHETER PULMONARY VALVE

    MDR report key: 10989755 · Received December 11, 2020

    Report

    Report Number
    2025587-2020-03752
    Event Type
    Injury
    Date Received
    December 11, 2020
    Date of Event
    September 26, 2014
    Report Date
    December 11, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPV
    PMA / PMN Number
    P140017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: BISHNOI R., ET AL. NUMED COVERED CHEATHAM-PLATINUM STENTTM FOR THE TREATMENT OR PREVENTION OF RIGHT VENTRICULAR OUTFLOW TRACT CONDUIT DISRUPTION DURING TRANSCATHETER PULMONARY VALVE REPLACEMENT. CATHETER CARDIOVASC INTERV, 2015 FEB 15;85(3):421-7. DOI: 10.1002/CCD.25682. PUBLISHED ONLINE 26 SEPTEMBER 2014. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. MEDTRONIC PRODUCTS REFERENCED: HANCOCK; CONTEGRA; MOSAIC (PMA#S P790007; H020003; P990064. PRODUCT CODES: LWR; MHW; DYE), MELODY (PMA# P140017. PRODUCT CODE: NPV). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING THE USE OF A COVERED WIRE STENT TO PREVENT RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) DISRUPTION/INJURY DURING TRANSCATHETER PULMONIC VALVE REPLACEMENT (TPVR). ALL DATA WERE COLLECTED RETROSPECTIVELY FROM MULTIPLE CENTERS BETWEEN SEPTEMBER 2009 AND JULY 2012. THE STUDY POPULATION INCLUDED 50 PATIENTS, 48 OF WHOM WERE IMPLANTED WITH MEDTRONIC MELODY BIOPROSTHETIC VALVES UNDER TPVR (NO SERIAL NUMBERS PROVIDED). OF THIS PATIENT POPULATION, FOUR HAD MEDTRONIC HANCOCK VALVED CONDUITS, TWO HAD MEDTRONIC CONTEGRA VALVED CONDUITS AND ONE HAD A MEDTRONIC MOSAIC BIOPROSTHETIC VALVE PREVIOUSLY IMPLANTED IN THE RVOT (NO SERIAL NUMBERS PROVIDED). AMONG ALL MEDTRONIC HANCOCK/CONTEGRA/MOSAIC PATIENTS, ADVERSE EVENTS INCLUDED: RVOT OBSTRUCTION/STENOSIS, CONDUIT CALCIFICATION AND PULMONIC REGURGITATION, REQUIRING TPVR AS TREATMENT, AND RVOT CONDUIT TEARS DISCOVERED PRIOR TO CONDUIT DILATATION/VALVE IMPLANTATION, REQUIRING COVERED STENT PLACEMENT IN THE RVOT. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. AMONG ALL MEDTRONIC MELODY PATIENTS, ADVERSE EVENTS INCLUDED: RVOT CONDUIT TEARS/RUPTURES AND PULMONARY HEMORRHAGE DURING OR AFTER BALLOON DILATATION AND TPVR, REQUIRING COVERED STENT PLACEMENT IN THE RVOT, CONDUIT REPLACEMENT SURGERY, PLEUROCENTESIS WITH CHEST TUB PLACEMENT TO STOP BLEEDING. MELODY VALVE INCOMPETENCE REQUIRED VALVE-IN-VALVE IMPLANTATION WITH SECOND MELODY VALVES FOR RESOLUTION. MULTIPLE STENT FRACTURES OCCURRED IN ONE PATIENT'S VALVE, RESULTING IN FRAGMENT EMBOLIZATION AND REQUIRING STENT PLACEMENT FOR PHYSICAL SUPPORT. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1458146 MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV MEDTRONIC HEART VALVES DIVISION PB 10

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R