BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHER PULMONARY

    MDR report key: 4102206 · Received September 19, 2014

    Report

    Report Number
    2025587-2014-00679
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    November 26, 2012
    Report Date
    October 8, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION, INCLUDING DEVICE AND PATIENT DEMOGRAPHIC DETAILS, HAS BEEN REQUESTED FROM THE ARTICLE¿S CONTACT. WITHOUT DEV ICE-IDENTIFYING INFORMATION, A SEARCH OF MEDTRONIC¿S DATABASE COULD NOT BE CONDUCTED TO DETERMINE IF THIS EVENT HAD PREVIOUSLY BEEN REPORTED OR IF THE DEVICE WAS RETURNED FOR ANALYSIS. (B)(4). "EMERGENCY SURGERY FOR EXTRINSIC CORONARY COMPRESSION AFTER PERCUTANEOUS PULMONARY VALVE IMPLANTATION" CARDIOLOGY IN THE YOUNG (2013), 23, 463¿465 AUTHORS: LUCIA MAURI, ALESSANDRO FRIGIOLA, GIANFRANCO BUTERA PAEDIATRIC CARDIOLOGY AND CARDIAC SURGERY ¿ IRCCS POLICLINICO SAN DONATO, SAN DONATO MILANESE, MILAN, ITALY DOI:10.1017/S1047951112001187.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    TO DATE, THE ARTICLE AUTHOR HAS NOT PROVIDED THE REQUESTED ADDITIONAL INFORMATION. WITHOUT THE SERIAL NUMBER, A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED. PERFORATION, OCCLUSION AND THROMBUS ARE KNOWN ADVERSE EVENTS AND ARE DOCUMENTED IN THE DEVICE RISK ASSESSMENT. THE INVESTIGATION WILL BE REOPENED AND A SUPPLEMENTAL REPORT FILED IF ADDITIONAL INFORMATION IS RECEIVED OR IF THE DEVICE IS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION OF A TRANSCATHETER PULMONARY VALVE THAT WAS EXPLANTED ONE HOUR AFTER IMPLANT DUE TO AN ACUTE ANTERO-SEPTAL NON-ST MYOCARDIAL INFARCTION (MI). THE INFORMATION WAS CONTAINED IN A MEDICAL JOURNAL ARTICLE EXAMINING CORONARY ARTERY COMPRESSION AFTER PERCUTANEOUS PULMONARY VALVE IMPLANTATION. THE MI WAS SECONDARY TO THE PARTIAL LACERATION OF THE CONDUIT AND THE CREATION OF A THROMBUS THAT RESULTED IN AN EXTRINSIC COMPRESSION OF LEFT ANTERIOR DESCENDENT CORONARY ARTERY. AN ELECTROCARDIOGRAM AND COMPUTED TOMOGRAPHY ANGIOGRAPHY REVEALED ST SEGMENT DEPRESSION (MYOCARDIAL INFARCTION) AND PARTIAL OBSTRUCTION OF THE PROXIMAL-MID TRACT OF THE LEFT ANTERIOR DESCENDENT CORONARY ARTERY DUE TO EXTRINSIC COMPRESSION NEAR THE SITE OF THE VALVE. UPON THE SUBSEQUENT EXPLANT OF THE VALVE, A LACERATION WAS FOUND ON THE LATERAL-POSTERIOR LEFT WALL OF THE DEVICE, WITH A THROMBUS EVIDENT BETWEEN THE TISSUE AND THE STENTS, COMPRESSING THE LEFT CORONARY ARTERY BENEATH IT. THE LACERATION WAS DUE TO A POST-DILATION OF THE DEVICE WITH A LARGER DIAMETER BALLOON. A PERICARDIAL PATCH WAS APPLIED AND A NON-MEDTRONIC VALVE WAS IMPLANTED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585091 MELODY TRANSCATHER PULMONARY PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV MEDTRONIC HEART VALVES DIVISION PB1018

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention