BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHER PULMONARY

    MDR report key: 4624842 · Received March 23, 2015

    Report

    Report Number
    2025587-2015-00352
    Event Type
    Injury
    Date Received
    March 23, 2015
    Date of Event
    December 3, 2014
    Report Date
    April 22, 2015
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    NPV
    PMA / PMN Number
    P140017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS WERE NOT RETURNED TO MEDTRONIC. (B)(4). TITLE: PERCUTANEOUS PULMONARY VALVE IMPLANTATION: 5 YEARS OF FOLLOW-UP. DOES AGE INFLUENCE OUTCOMES? AUTHORS: SHARON BORIK, MD; ANDREW CREAN, MD, FRCPC; ERIC HORLICK, MDCM, FRCPC; MARK OSTEN, MD, FRCPC; KYONG-JIN LEE, MD, FRCPC; RAJIV CHATURVEDI, MD, PHD, MRCP(UK); MARK K. FRIEDBERG, MD; BRIAN W. MCCRINDLE, MD, FRCPC; CEDRIC MANLHIOT, BSC; LEE BENSON, MD, FRCPC JOURNAL CITATION: CIRCULATION CARDIOVASCULAR INTERVENTIONS; 2015;8:E001745 DOI: 10.1161/CIRCINTERVENTIONS.114.00174.

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED TO ATTACH LITERATURE; NO OTHER ADDITIONS OR CHANGES.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE STERILIZATION PROCESS USED BY MEDTRONIC HAS AN ANTI-MICROBIAL KILL ON THE MICROORGANISMS SUCH AS STAPHYLOCOCCUS AND STREPTOCOCCUS SPECIES. THE REPORTED ORGANISM CAN BE RENDERED NON-VIABLE TO THE STERILIZATION PROCESS DURING MANUFACTURING. THIS PROCESS IS VALIDATED USING THE WORST CASE BACILLUS ATROPHAUS (GRAM POSITIVE SPORE FORMING RODS), WHICH IS KNOWN TO BE REPRESENTATIVE OF THE CLEANROOM BIOBURDEN AND OUR PROCESS IS VALIDATED IS EFFECTIVE. ENDOCARDITIS THAT OCCURS MORE THAN 12 MONTH AFTER THE PROCEDURE ARE CALLED LATE PROSTHETIC-VALVE ENDOCARDITIS AND ARE LARGELY COMMUNITY-ACQUIRED VERSUS A RESULT OF THE MANUFACTURING PROCESS OF THE VALVE. BASED ON CLINICAL DATA AND LITERATURES, MELODY STENT FRACTURES ARE KNOWN PHENOMENON. PROMINENT MECHANICAL STRESSES ON THE OUTFLOW TRACT STENT, SUCH AS COMPRESSION BETWEEN THE ANTERIOR CHEST WALL AND HEART, APPEAR TO BE ASSOCIATED WITH AN INCREASED RISK OF STENT FRACTURE. HOWEVER, A TRUE ROOT CAUSE TO THE STENT FRACTURES WAS NOT DETERMINED. OVERALL, A TRUE ROOT CAUSE TO THE REPORTED CLINICAL OBSERVATIONS WAS NOT DETERMINED.

    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 THAT A STUDY WAS PERFORMED TO ASSESS THE PERSISTENCE OF REVERSE RIGHT VENTRICLE (RV) REMODELING FOLLOWING PERCUTANEOUS PULMONARY VALVE IMPLANTATION (PPVI) AS WELL AS THE TIMING PPVI INFLUENCED OUTCOMES. THE STUDY INCLUDED 51 PATIENTS (INCLUDING 23 PATIENTS <(><<)>16 YEARS OLD) WHO UNDERWENT IMPLANTATION OF A MEDTRONIC BIOPROSTHETIC PULMONARY VALVE AND WERE FOLLOWED FOR A MEAN OF 4.5 YEARS POST-IMPLANT BETWEEN OCTOBER 2005 AND OCTOBER 2011. THE PATIENT POPULATION WAS PREDOMINANTLY MALE WITH A MEAN AGE OF 20.2 (±10.8) YEARS OLD, AND A MEAN WEIGHT OF 58.3 (±16.0) KILOGRAMS. FREEDOM FROM ANY RE-INTERVENTION WAS 87% AND 68% AT 3 AND 5 YEARS RESPECTIVELY, AND FREEDOM FROM SURGERY WAS 90% AT 5 YEARS. THERE WERE FIVE OPEN CHEST SURGICAL INTERVENTIONS, WHICH INCLUDED RV TO PULMONARY ARTERY CONDUIT REPLACEMENTS (N=2), PULMONARY VALVE REPLACEMENT (N=1), ARTERIAL SWITCH OPERATION (N=1), AND AN AORTIC VALVE AND ROOT REPLACEMENT WITH PULMONARY HOMOGRAFT IMPLANTATION FOR INFECTIOUS ENDOCARDITIS (N=1). THE PATIENT WITH ENDOCARDITIS PRESENTED FIVE YEARS POST-PPVI WITH GRAM-POSITIVE COCCI ON THE IMPLANTED VALVE. THERE WERE SEVEN PERCUTANEOUS SURGICAL INTERVENTIONS, WHICH INCLUDED RE-VALVING (NEW BIOPROSTHETIC VALVE IMPLANTED WITHIN ORIGINAL BIOPROSTHETIC VALVE; N=5), AND BALLOON VALVULOPLASTY DILATIONS (N=2) TO ADDRESS STENOSIS OR RV HYPERTENSION. ALSO, 18% OF PATIENTS (N=9) HAD EVIDENCE OF MINOR TYPE 1 STENT FRACTURES VIA DIGITAL CHEST RADIOGRAPHY, AND 3% OF PATIENTS (N=1) EXHIBITED STENT FRACTURE WITH LOSS OF STENT INTEGRITY WHICH REQUIRED RE-VALVING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192810 MELODY TRANSCATHER PULMONARY PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV HEART VALVES SANTA ANA PB1018

    Patients

    Seq Age Sex Outcome Treatment
    1 00020 YR Life Threatening| R