BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCEVAL SUTURELESS AORTIC HEART VALVE

    MDR report key: 8677035 · Received June 6, 2019

    Report

    Report Number
    3004478276-2019-00174
    Event Type
    Injury
    Date Received
    June 6, 2019
    Date of Event
    April 26, 2019
    Report Date
    July 4, 2019
    Manufacturer
    LIVANOVA CANADA CORP.
    Product Code
    LWR
    UDI-DI
    00896208000436
    PMA / PMN Number
    P150011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION AND THE FOLLOWING UPDATED EVENT DESCRIPTION HAS BEEN INCLUDED IN SECTION B5: LNJ WAS INFORMED THAT THE PATIENT ON (B)(6) EXPERIENCED AV BLOCK AGAIN AND HAD PACEMAKER IMPLANTED DURING GOLDEN WEEK (JAPANESE NATIONAL HOLIDAYS, (B)(6)). ADDITIONAL INFORMATION WAS RECEIVED IDENTIFYING THE PATIENTS VALVE IS FUNCTIONING NORMALLY AND THE PATIENT IS STABLE. NO INFORMATION ABOUT PRE-EXISTING RISK, HISTORY AND OR PRIOR PROCEDURES WAS RECEIVED. A CONCOMITANT BYPASS LITA-LAD WAS PERFORMED DURING PERCIVAL IMPLANT. BASED ON INTERNAL ASSESSMENT, THE RELATIONSHIP OF THE DEVICE TO THE IDENTIFIED CONDUCTION DISORDER WAS DEEMED TO BE UNKNOWN. THE EVENT WAS THEREFORE REPORTED IN A CONSERVATIVE MANNER. THE MANUFACTURING AND MATERIAL RECORDS FOR THE PERCIVAL HEART VALVE, MODEL #ICV1210 , S/N #(B)(6) , 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 (MODEL #ICV1210) PERCIVAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. AS THE DEVICE REMAINS IMPLANTED NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. CONDUCTION DISORDERS ARE COMMON IN PATIENTS WITH AORTIC VALVE DISEASES. AS A RESULT, IT IS COMMON FOR PATIENTS TO RECEIVE A PERMANENT PACEMAKER IMPLANTATION AFTER AORTIC VALVE REPLACEMENT. RISK FACTORS INCLUDE PREEXISTING CONDUCTING DISEASE AND PREOPERATIVE AORTIC REGURGITATION. THIS EVENT IS THEREFORE A KNOWN, INHERENT RISK OF THE PROCEDURE; HOWEVER, THE ROOT CAUSE OF THIS EVENT REMAINS UNKNOWN. FIELDS CHANGED: B4, B5, G4, G7, H2, H6.

    Description of Event or Problem · 0

    LNJ WAS INFORMED THAT THE PATIENT ON #(B)(6) EXPERIENCED AV BLOCK AGAIN AND HAD PACEMAKER IMPLANTED DURING GOLDEN WEEK (JAPANESE NATIONAL HOLIDAYS, (B)(6)). ADDITIONAL INFORMATION WAS RECEIVED IDENTIFYING THE PATIENTS VALVE IS FUNCTIONING NORMALLY AND THE PATIENT IS STABLE. NO INFORMATION ABOUT PRE-EXISTING RISK, HISTORY AND OR PRIOR PROCEDURES WAS RECEIVED. A CONCOMITANT BYPASS LITA-LAD WAS PERFORMED DURING PERCEVAL IMPLANT.

    Additional Manufacturer Narrative · 1

    DEVICE NOT EXPLANTED.

    Description of Event or Problem · 1

    A PATIENT RECEIVED PERCEVAL PVS25 AS PART OF AN AVR ON (B)(6) 2019. LIVANOVA WAS INFORMED THAT THE PATIENT EXPERIENCED AV BLOCK AND HAD PACEMAKER IMPLANTED DURING (B)(6) WEEK ((B)(6)). NO FURTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467121 PERCEVAL SUTURELESS AORTIC HEART VALVE TISSUE HEART VALVE LWR LIVANOVA CANADA CORP. PVS25 00896208000436

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Disability