BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHER PULMONARY

    MDR report key: 4488286 · Received February 5, 2015

    Report

    Report Number
    2025587-2015-00130
    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
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    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

    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 ELEVEN PATIENTS EXPERIENCED MINOR PROCEDURAL COMPLICATIONS DURING THE IMPLANT OF A TRANSCATHETER PULMONARY VALVE (TPV). THE INFORMATION WAS REPORTED FROM A MULTI-CENTER RETROSPECTIVE STUDY OF 64 PATIENTS OVER A 32-MONTH PERIOD. THE PROCEDURAL ISSUES INCLUDED CONFINED TEARS OF AN UNIDENTIFIED HOMOGRAFT CONDUIT, MINOR BLEEDING FROM THE OROTRACHEAL TUBE WITH SPONTANEOUS RESOLUTION; A FALSE ANEURYSM OF THE LEFT FEMORAL ARTERY TREATED SUCCESSFULLY WITH LOCAL COMPRESSION; A BLOOD TRANSFUSION REQUIREMENT DUE TO BLEEDING AT THE FEMORAL ACCESS SITE; AND A GROIN HEMATOMA. THE ARTICLE CONTAINED NO ADDITIONAL INFORMATION REGARDING THE ISSUE OR OUTCOME. THE ARTICLE REPORTED A 100% SUCCESS RATE FOR INITIAL IMPLANTS. THE IMPLANTED DEVICE SIZES RANGED FROM 18-22MM. THE MEDIAN AGE OF PATIENTS WAS 21 YEARS (RANGE OF 10.5-77.3 YEARS), AND 60% OF THE PATIENTS WERE FEMALE. IT WAS REPORTED THAT TWO PATIENTS WITH IMPLANTED TPVS DIED AFTER EXPERIENCING INFECTIVE ENDOCARDITIS; A REVIEW OF MEDTRONIC¿S DATABASES SHOWED BOTH EVENTS WERE PREVIOUSLY REPORTED TO MEDTRONIC. ONE EVENT OCCURRED PRIOR TO THE DEVICE BEING COMMERCIALLY AVAILABLE IN THE UNITED STATES; INVESTIGATION FOUND THAT AN UNSPECIFIED TYPE OF ENDOCARDITIS WAS IDENTIFIED AFTER THE PATIENT WAS ADMITTED TO A HOSPITAL, AND THAT THE PATIENT HAD BEEN ADMITTED WITHOUT SIGNS OF INFECTION. IN THE SECOND CASE, THE PATIENT DIED FROM MULTI-ORGAN FAILURE AFTER EXPERIENCING ENDOCARDITIS MORE THAN 28 MONTHS AFTER TPV IMPLANT; INVESTIGATION FOUND NO ISSUES WITH THE DEVICE¿S MANUFACTURING OR THE STERILIZATION PROCESS. THE ARTICLE ALSO NOTED A THIRD PATIENT DIED FROM END-STAGE CARDIAC FAILURE, WITH A PRE-EXISTING DEPRESSED RIGHT VENTRICULAR FUNCTION THAT DID NOT IMPROVE AFTER TPV IMPLANT, WHILE THE PATIENT WAS BEING CONSIDERED FOR A HEART TRANSPLANT. IT ALSO WAS REPORTED THAT THREE PATIENTS UNDERWENT POST-IMPLANT RE-INTERVENTIONS; SEPARATE REPORTS HAVE BEEN FILED FOR THOSE CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84268 MELODY TRANSCATHER PULMONARY PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV MEDTRONIC HEART VALVES DIVISION PB1018

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention