BEUDAMED
    FDA Adverse Event Death Summary report: N

    CROWN PRT PERICARDIAL HEART VALVE

    MDR report key: 9514180 · Received December 23, 2019

    Report

    Report Number
    1718850-2019-01218
    Event Type
    Death
    Date Received
    December 23, 2019
    Date of Event
    September 21, 2018
    Report Date
    March 4, 2020
    Manufacturer
    LIVANOVA CANADA CORP.
    Product Code
    LWR
    UDI-DI
    00896208000153
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION ON (B)(6)2020 IDENTIFYING THE FOLLOWING. THE PATIENT HAD AN INCREASE IN DYSPNEA AS WELL AS ANGIOGENIC PALPITATIONS. THE SVD WAS IDENTIFIED THROUGH AN INCREASING TRANSVALVULAR GRADIENT. IN 2015 10 MMHG, 2016 31 MMHG, 2017 39 MMHG, AND 2018 : 55 MMHG. NO DEVICE IMAGING IS AVAILABLE FOR ANALYSIS. THE PATIENT DEATH WAS SUDDEN AND A RESULT OF RESPIRATORY DISTRESS. TOMODENSITOMETRY IDENTIFIED A POSSIBLE PULMONARY INFECTION RATHER THAN PULMONARY EDEMA. THE PATIENT MEDICATION WAS BETABLOCKERS BISOPROLOL; ARA II: CANDESARTAN; ASPIRIN 160 MG. THE MANUFACTURING AND MATERIAL RECORDS FOR THE MITROFLOW BIOPROSTHETIC PERICARDIAL HEART VALVE, MODEL # DLA19, S/N # 371081, AS THEY PERTAIN TO THE REPORTED EVENT, WERE RETRIEVED AND REVIEWED BY QUALITY ENGINEERING AT LIVANOVA CANADA CORP. THE RESULTS CONFIRMED THAT THIS VALVE SATISFIED ALL MATERIAL, VISUAL, AND PERFORMANCE STANDARDS REQUIRED FOR A DLA19 MITROFLOW AORTIC PERICARDIAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. BASED ON THE INFORMATION RECEIVED THE ROOT CAUSE OF DEATH WAS IDENTIFIED AS SUDDEN RESPIRATORY DISTRESS. AS THE DEVICE IS NOT AVAILABLE FOR ANALYSIS THE MANUFACTURER CANNOT PERFORM ANY FURTHER INVESTIGATIONS. AS NO INFORMATION REGARDING THE DEVICE CONDITION, OR FACTORS THAT MAY HAVE LEAD TO THE INCREASING GRADIENT ARE AVAILABLE THE MANUFACTURER CANNOT PRESENTLY IDENTIFY THE EXACT ROOT CAUSE OF THE SVD. IT IS POSSIBLE THAT THE PATIENT'S RISK FACTORS (DYSLIPIDEMIA) CONTRIBUTED TO THE REPORTED STRUCTURAL VALVE DETERIORATION. HOWEVER, SINCE NO INVESTIGATION COULD BE PERFORMED, THIS CANNOT BE ULTIMATELY CONFIRMED. STRUCTURAL VALVE DETERIORATION IS LISTED AS A POSSIBLE ADVERSE EVENT IN THE PERCEVAL IFU. THE EVENT IS, THEREFORE, A KNOWN INHERENT RISK OF THE DEVICE.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION ON (B)(6)2020 IDENTIFYING THE FOLLOWING. THE PATIENT HAD AN INCREASE IN DYSPNEA AS WELL AS ANGIOGENIC PALPITATIONS. THE SVD WAS IDENTIFIED THROUGH AN INCREASING TRANSVALVULAR GRADIENT. IN 2015 10 MMHG, 2016 31 MMHG, 2017 39 MMHG, AND 2018 : 55 MMHG. NO DEVICE IMAGING IS AVAILABLE FOR ANALYSIS. THE PATIENT DEATH WAS SUDDEN AND A RESULT OF RESPIRATORY DISTRESS. TOMODENSITOMETRY IDENTIFIED A POSSIBLE PULMONARY INFECTION RATHER THAN PULMONARY EDEMA.

    Description of Event or Problem · 1

    ON (B)(6) 2014 A PATIENT RECEIVED A MITROFLOW DLA19 AS PART OF AN AVR. THE MANUFACTURER WAS NOTIFIED THAT ON THE (B)(6) 2018 THE PATIENT PASSED AWAY DUE TO CARDIOVASCULAR MORTALITY, STRUCTURAL VALVE DETERIORATION. NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305497 CROWN PRT PERICARDIAL HEART VALVE TISSUE HEART VALVE LWR LIVANOVA CANADA CORP. DLA19 00896208000153

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death