BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHER PULMONARY

    MDR report key: 4488273 · Received February 5, 2015

    Report

    Report Number
    2025587-2015-00131
    Event Type
    Injury
    Date Received
    February 5, 2015
    Date of Event
    October 30, 2014
    Report Date
    March 17, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPV
    PMA / PMN Number
    P140017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, ADDITIONAL INFORMATION HAS NOT BEEN OBTAINED FROM THE ARTICLE¿S AUTHORS. REGURGITATION IS A KNOWN ADVERSE EVENT. THIS DEVICE IS NOT INTENDED TO BE IMPLANTED IN THE TRICUSPID POSITION. THE DEVICE HAS BEEN APPROVED FOR IMPLANTATION INTO DYSFUNCTIONAL RIGHT VENTRICULAR OUTFLOW TRACT CONDUITS. BASED ON THE AVAILABLE INFORMATION, IT IS UNKNOWN IF THE DEVICE CAUSE OR CONTRIBUTED TO THE CLINICAL OBSERVATION. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    THIS PATIENT WAS ONE OF THREE CITED IN THE ARTICLE WHO EXPERIENCED A POST-IMPLANT INTERVENTION; SEPARATE REPORTS HAVE BEEN FILED FOR THE OTHER TWO PATIENTS AND ISSUES REPORTED IN THE ARTICLE. ADDITIONAL INFORMATION IS BEING SOUGHT FROM THE ARTICLE¿S AUTHOR CONTACT. (B)(4). ARTICLE: MELODY TRANSCATHETER PULMONARY VALVE IMPLANTATION: RESULTS FROM A FRENCH REGISTRY AUTHORS: ALAIN FRAISSE, PHILIPPE ALDEBERT, SOPHIE MALEKZADEH-MILANIB, JEAN-BENOIT THAMBOD, JEAN-FRANCOIS PIÉCHAUD, PASCALINE AUCOURURIER, GILLES CHATELIER, DAMIEN BONNET, LAURENCE ISERIN, BÉATRICE BONELLO, ANASS ASSAIDI, ISSAM KAMMACHE, YOUNES BOUDJEMLINE. ARCHIVES OF CARDIOVASCULAR DISEASE (2014) 107, 607¿614 DX.DOI.ORG/10.1016/J.ACVD.2014.10.001

    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 FROM A MEDICAL JOURNAL ARTICLE THAT A PATIENT WITH AN IMPLANTED TRANSCATHETER PULMONARY VALVE (TPV) UNDERWENT DEVICE EXPLANT AND REPLACEMENT WITH A HOMOGRAFT. IT WAS REPORTED THAT THE PATIENT¿S TRICUSPID REGURGITATION DID NOT IMPROVE AFTER TPV IMPLANT, AND THE DEVICE WAS REPLACED 30 MONTHS AFTER ITS IMPLANT DURING A TRICUSPID ANNULOPLASTY. THE ARTICLE CONTAINED NO ADDITIONAL INFORMATION REGARDING THE ISSUE OR OUTCOME. THE INFORMATION WAS REPORTED FROM A MULTI-CENTER RETROSPECTIVE STUDY OF 64 PATIENTS OVER A 32-MONTH PERIOD. THE ARTICLE REPORTED A 100% SUCCESS RATE FOR INITIAL IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83682 MELODY TRANSCATHER PULMONARY PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV MEDTRONIC HEART VALVES DIVISION PB1018

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention