BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHER PULMONARY

    MDR report key: 4488316 · Received February 5, 2015

    Report

    Report Number
    2025587-2015-00133
    Event Type
    Injury
    Date Received
    February 5, 2015
    Date of Event
    October 30, 2014
    Report Date
    October 7, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ARTICLE'S AUTHOR CONTACT SUBSEQUENTLY REPORTED THE TPV WAS REPLACED WITH A HOMOGRAFT. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE DEVICE'S SERIAL NUMBER OR THE CAUSE OF ITS OBSTRUCTION.

    Additional Manufacturer Narrative · 1

    TO DATE, ADDITIONAL INFORMATION HAS NOT BEEN OBTAINED FROM THE ARTICLE¿S AUTHORS. STENOSIS, REGURGITATION, BLEEDING, HEMATOMA AND PSEUDOANEURYSM ARE KNOWN ADVERSE EVENTS. 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. WITHOUT DEVICE-IDENTIFYING INFORMATION, A REVIEW FOR DEVICE HISTORY OR RETURN COULD NOT BE CONDUCTED. ADDITIONAL INFORMATION IS BEING SOUGHT FROM THE ARTICLE¿S AUTHOR CONTACT. (B)(6). 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A MEDICAL JOURNAL ARTICLE THAT AN UNSPECIFIED SURGICAL RE-INTERVENTION WAS REQUIRED AT 24 MONTHS POST-IMPLANT FOR A PATIENT WHOSE TRANSCATHETER PULMONARY VALVE (TPV) EXPERIENCED CONDUIT OBSTRUCTION. THE ARTICLE CONTAINED NO ADDITIONAL INFORMATION REGARDING THE DEVICE, THE DEVICE 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
    84278 MELODY TRANSCATHER PULMONARY PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV MEDTRONIC HEART VALVES DIVISION PB1018

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention