BEUDAMED
    FDA Adverse Event Death Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 4152070 · Received October 8, 2014

    Report

    Report Number
    2025587-2014-00742
    Event Type
    Death
    Date Received
    October 8, 2014
    Report Date
    September 12, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE.

    Additional Manufacturer Narrative · 1

    CONCLUSION: WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. NO CAUSE OF DEATH WAS PROVIDED. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA A JOURNAL ARTICLE TITLED ¿A COMPARISON OF OUTCOMES BETWEEN BOVINE PERICARDIAL AND PORCINE VALVES IN 38,040 PATIENTS IN ENGLAND AND WALES OVER 10 YEARS¿(EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY DOI:10.1093/EJCTS/EZU307). THE ARTICLE COMPARED THE PERFORMANCE OF PORCINE AND BOVINE PERICARDIAL VALVES IMPLANTED IN AORTIC VALVE REPLACEMENT (AVR) SURGERY WITH RESPECT TO SURVIVAL AND REINTERVENTION-FREE SURVIVAL IN A RETROSPECTIVE OBSERVATIONAL STUDY. A TOTAL OF 38,040 PATIENT WERE INCLUDED IN THE STUDY, OF THAT NUMBER 6,192 PATIENTS HAD MEDTRONIC PORCINE VALVES AND WERE IMPLANTED IN ENGLAND AND WALES BETWEEN APRIL 1, 2003 THROUGH MARCH 31, 2013. OUTCOMES FOR THIS STUDY LOOKED AT IN-HOSPITAL MORTALITY, DEFINED AS DEATH DUE TO ANY CAUSE DURING ADMISSION TO THE BASE HOSPITAL FOR SURGERY, MID-TERM SURVIVAL FROM ALL-CAUSE MORTALITY AND REINTERVENTION-FREE MID-TERM SURVIVAL. IT WAS NOTED IN THE ARTICLE THAT THE DATA ON THE CAUSE OF DEATH FOR THESE PATIENTS WAS UNAVAILABLE. IT WAS REPORTED THAT THERE WAS 406 PORCINE IN-HOSPITAL DEATHS, OF THAT NUMBER IT IS UNKNOWN HOW MANY HAD MEDTRONIC DEVICES. THERE WERE 3,079 DEATHS DURING THE FOLLOW-UP PERIOD WITH PATIENTS WHO HAD PORCINE VALVES, OF THAT NUMBER IT IS UNKNOWN HOW MANY OF THEM HAD MEDTRONIC DEVICES. AGAIN, THE CAUSE OF DEATH IS UNKNOWN. IN THE PORCINE GROUP SURVIVAL AT 10 YEARS POST IMPLANT WAS AT 50.3%. A TOTAL OF 387 PATIENTS HAD REINTERVENTION FROM BOTH BOVINE AND PORCINE GROUP, 376 HAD ONE REINTERVENTION PERFORMED AND 11 HAD TWO RE-INTERVENTIONS PERFORMED. THE REASON FOR INTERVENTION IS UNKNOWN. THE CONCLUSION TO THE ARTICLE IS WITH OVER 10 YEARS OF FOLLOW-UP, THERE IS NO STATISTICALLY SIGNIFICANT DIFFERENCE IN THE PERFORMANCE OF BOVINE PERICARDIAL AND PORCINE BIOPROSTHESIS IMPLANTED INTO FIRST-TIME CARDIAC PATIENTS UNDERGOING AORTIC VALVE REPLACEMENT (AVR). THE STUDY DID NOT ANALYZE THE DATA FOR SPECIFIC MODEL TYPE WITHIN THE TWO CLASSES OF VALVES, SO IT REMAINS POSSIBLE THAT SPECIFIC VALVE MODELS MAY BE ASSOCIATED WITH DIFFERENT SURVIVAL CHARACTERISTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632584 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Death