BEUDAMED
    FDA Adverse Event Death Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 4200998 · Received October 27, 2014

    Report

    Report Number
    2025587-2014-00790
    Event Type
    Death
    Date Received
    October 27, 2014
    Date of Event
    July 19, 2010
    Report Date
    September 29, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PRODUCTS IN THE ARTICLE WERE UNSUCCESSFUL. WITHOUT THE RETURN OF THE PRODUCT(S), NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION(S). (B)(4). CITATION: TITLE:"RASTELLI OPERATION FOR TRANSPOSITION OF THE GREAT ARTERIES WITH VENTRICULAR SEPTAL DEFECT AND PULMONARY STENOSIS" AUTHORS: JOHN W. BROWN, MD, MARK RUZMETOV, MD, PHD, DANIEL HUYNH, BS, MARK D. RODEFELD, MD, MARK W. TURRENTINE, MD, AND ANDREW C. FIORE, MD SECTION OF CARDIOTHORACIC SURGERY, INDIANA UNIVERSITY SCHOOL OF MEDICINE, INDIANAPOLIS, INDIANA; AND ST. LOUIS UNIVERSITY SCHOOL OF MEDICINE, ST. LOUIS, MISSOURI THE ANNALS OF THORACIC SURGERY; 2011;91:188¿94.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A RETROSPECTIVE STUDY IN THE ANNALS OF THORACIC SURGERY; (B)(6) 2011; 91:188¿94, THAT SUMMARIZED THE 20-YEAR EXPERIENCE OF THE RASTELLI PROCEDURE TO TREAT TRANSPOSITION OF THE GREAT ARTERIES (TGA) AND PULMONARY STENOSIS (PS) IN PEDIATRIC PATIENTS. BETWEEN 1988 AND 2008, 40 PATIENTS UNDERWENT RO (MEDIAN AGE 4 YEARS; RANGE 9 MONTHS TO 17 YEARS; 24 MALE, 16 FEMALE) . THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) WAS OBSTRUCTED IN 32 AND ATRETIC IN 8 PATIENTS. THE RIGHT VENTRICULAR (RV) TO PULMONARY ARTERY (PA) WAS RECONSTRUCTED WITH A HOMOGRAFT (N=25), CONTEGRA BOVINE JUGULAR VEIN CONDUIT (N=8), POLYETHYLENE TEREPHTHALATE FIBER NONVALVED GRAFT CONDUIT (N=5) OR FREESTYLE PORCINE VALVED ROOT (N=2). THE MEAN SIZE OF THE RV-PA CONDUIT WAS 17.3 PLUS OR MINUS 2.33 MM (RANGE 13 TO 22 MM). WITHIN A MEAN FOLLOW-UP OF 8.6 YEARS, THERE WAS: 1) ONE EARLY REOPERATION FOR BLEEDING. NO ADVERSE PATIENT EFFECTS WERE REPORTED. 2) PERMANENT PACEMAKERS WERE IMPLANTED POST-OPERATIVELY IN 5 PATIENTS FOR PERMANENT ATRIO-VENTRICULAR (AV) BLOCK (N=2) COMPLETE AV BLOCK (N=2), AND SICK SINUS SYNDROME (N=1). NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. 3) THERE WERE 3 LATE DEATHS AND ONE CARDIAC TRANSPLANTATION. THE FIRST DEATH OCCURRED IN A PATIENT WITH CORONARY ARTERY ANOMALY (RV BRANCHES ARISING FROM THE LEFT CORONARY ARTERY) WHO DIED SUDDENLY 1 YEAR POSTOPERATIVELY. THIS PATIENT HAD DOCUMENTED SINUS RHYTHM AND NO OBSTRUCTION. THE SECOND DEATH PRESENTED WITH MULTIPLE STENOSES OF THE PERIPHERAL AND CENTRAL PULMONARY ARTERIES AND KLIPPEL-FEIL SYNDROME, WITH MULTIPLE SKELETAL AND RIB ANOMALIES. THE PATIENT DIED OF LOW CARDIAC OUTPUT 3 MONTHS AFTER THE RO. THE THIRD DEATH WAS IN A PATIENT WITH A MYELOMENINGOCELE WHO EXPIRED AT ANOTHER HOSPITAL 6 MONTHS AFTER RO SECONDARY TO PNEUMONIA AND SEPSIS. A FOURTH PATIENT UNDERWENT TWO REINTERVENTIONS FOR PACEMAKER EXCHANGE DUE TO COMPLETE ATRIOVENTRICULAR BLOCK. BEFORE CARDIAC TRANSPLANTATION (12 YEARS AFTER RO), HE PRESENTED WITH SEVERELY IMPAIRED RIGHT AND LEFT VENTRICULAR FUNCTION WITH END-STAGE HEART FAILURE AND EJECTION FRACTION OF 15%. 4) SIXTEEN PATIENTS HAD REOPERATION FOR RV-PA CONDUIT STENOSIS (MEAN 7.8 PLUS OR MINUS 3.8 YEARS) WITHOUT MORTALITY. TWO PATIENTS REQUIRED REOPERATION FOR LEFT VENTRICULAR OUTFLOW TRACT (LVOT) OBSTRUCTION DUE TO SCAR FORMATION WITHIN THE BAFFLE PATHWAY FROM THE VENTRICULAR SEPTAL DEFECT (VSD) TO THE AORTIC VALVE. THE AVERAGE TIME TO CONDUIT FAILURE WAS 7.8 PLUS OR MINUS 3.8 YEARS (RANGE 2 TO 16 YEARS). THE MEAN AGE AT REOPERATION WAS 12 PLUS OR MINUS 6 YEARS (RANGE 4 TO 27 YEARS). THE PEAK SYSTOLIC GRADIENT ACROSS THE RVOT BEFORE CONDUIT REPLACEMENT WAS 59 PLUS OR MINUS 8 MM HG (RANGE 30 TO 80 MMHG). THE MOST COMMON INDICATION FOR CONDUIT REPLACEMENT WAS STENOSIS, WHICH WAS PRESENT IN 14 OF THE 16 REPLACEMENT PROCEDURES. A LESS FREQUENT PRIMARY INDICATION FOR CONDUIT REPLACEMENT WAS CONDUIT VALVE INSUFFICIENCY, NOTED IN 2 PATIENTS. ALL CONDUITS THAT REQUIRED REPLACEMENT HAD VARYING DEGREES OF INSUFFICIENCY (MILD=6, MODERATE=8, SEVERE=2). THIRTEEN PATIENTS UNDERWENT REPLACEMENT WITH A SECOND BIOLOGIC VALVE, WHILE 3 HAD THE CONDUIT REVISED WITH THE INSERTION OF A POLYTETRAFLUROETHYLENE MONOCUSP VALVE. OF THE 18 PATIENTS WHO DID NOT REQUIRE REOPERATION, FREEDOM FROM LVOT OBSTRUCTION OR AORTIC INSUFFICIENCY WAS 89% AND 95%, RESPECTIVELY. ONE PATIENT HAD A 22 MMHG LVOT OBSTRUCTION GRADIENT, AND ANOTHER HAD MILD AORTIC INSUFFICIENCY. TWO PATIENTS PRESENTED WITH MODERATE STENOSIS OF THE CONDUIT (41 AND 47 MMHG); NO TREATMENT WAS PRESCRIBED AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT LAST FOLLOW-UP, SINUS RHYTHM WITH COMPLETE RIGHT BUNDLE BRANCH BLOCK (RBBB) WAS PRESENT IN 31 PATIENTS. IT IS UNKNOWN IF A MEDTRONIC PRODUCT WAS RELATED TO THE REPORTED DEATHS, REOPERATIONS OR PACEMAKER IMPLANTATIONS. THE DATE OF DEATH(S) IS AN APPROXIMATE DATE BASED ON DAY OF THE COMPLETION OF THE STUDY. THE AGE AND WEIGHT OF THE PATIENT(S) IS THE MEAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684658 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 00004 YR Death| R