BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCEVAL SUTURELESS AORTIC HEART VALVE

    MDR report key: 8823766 · Received July 24, 2019

    Report

    Report Number
    3004478276-2019-00222
    Event Type
    Injury
    Date Received
    July 24, 2019
    Report Date
    October 25, 2019
    Manufacturer
    LIVANOVA CANADA CORP.
    Product Code
    LWR
    UDI-DI
    00896208000436
    PMA / PMN Number
    P150011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING AND MATERIAL RECORDS FOR THE PERCEVAL 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) PERCEVAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE.

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2017 A PATIENT RECEIVED A PERCEVAL PVS25, SUTURELESS AORTIC HEART VALVE, AS PART OF A AORTIC VALVE REPLACEMENT. THE MANUFACTURER WAS NOTIFIED THAT ON MARCH 09, 2019 THE VALVE WAS EXPLANTED AND A PERCEVAL PVS21 WAS IMPLANTED. THE EXPLANT OCCURRED AT INSTITUTE (B)(6) AND INVOLVED DR. (B)(6). ON OCTOBER 8TH THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION FROM THE SITE. THE EVENT WAS A RESULT IF ENDOCARDITIS. THERE WERE NO IDENTIFIED DEVICE MALFUNCTIONS. THE DEVICE IS NOT AVAILABLE FOR RETURN OR ANALYSIS. THE CHANGE IN SIZE WAS A RESULT OF A CURED ANNULAR ABSCESS WITH A AUTOLOGUS PERICARDIAL PATCH, THUS REDUCING THE SIZE OF THE ANNULUS. THE PATIENT HAD A GOOD POST OPERATIVE EVOLUTION AND WAS STABLE DURING PROCEDURE. THE MANUFACTURING AND MATERIAL RECORDS FOR THE PERCEVAL 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) PERCEVAL HEART VALVE AT THE TIME OF MANUFACTURE AND RELEASE. IF AN INFECTIOUS MICROORGANISM (IMO) WAS PRESENT ON THE TISSUE VALVE BEFORE STERILIZATION, IT WOULD BE KILLED VERY EASILY BY THE MANUFACTURERS LIQUID CHEMICAL STERILANT. THE STERILANT CONTAINS A MIXTURE OF GLUTARALDEHYDE AND ALCOHOL, BOTH OF WHICH ARE HIGHLY EFFECTIVE AGAINST IMO'S. THE MANUFACTURER HAS VALIDATED THIS LIQUID CHEMICAL STERILIZATION PROCESS WITH SPORE FORMING BACILLUS ATROPHAEUS, WHICH IS THE MOST RESISTANT MICROORGANISM KNOWN FOR ALDEHYDES. FOLLOWING ROUTINE STERILIZATION, THE VALVES ARE ASEPTICALLY PACKAGED IN A SOLUTION THAT INHIBITS GROWTH OF IMO'S WITH STEAM STERILIZED CLOSURES AND JARS. THE PACKAGING PROCESS OCCURS IN A VAPOROUS HYDROGEN PEROXIDE (VHP) DECONTAMINATED ISOLATOR; THUS THERE IS NO RISK OF VALVE CONTAMINATION POST-STERILIZATION. EACH CLOSURE/JAR CONTAINING THE VALVE IS INTEGRITY TESTED AFTER PACKAGING, THUS ENSURING A SEALED BARRIER FOR THE PRODUCT TO REMAIN STERILE DURING TRANSPORT UP UNTIL THE CLOSURE/JAR IS OPENED. BASED ON THE VERIFICATION OF DEVICE STERILIZATION AND THE FOLLOW-UP FROM THE SITE IDENTIFYING NO DEVICE MALFUNCTIONS WERE IDENTIFIED THIS EVENT IS DEEMED TO BE NOT VALVE RELATED AND CAN REASONABLY BE ATTRIBUTED TO PATIENT FACTORS. THE CONCLUSION IS DEEMED TO BE: CAUSE CANNOT BE TRACED TO DEVICE : ADVERSE EVENT RELATED TO PATIENT CONDITION. FIELDS CHANGED: B4, B5, G4, G7, H2, H6.

    Description of Event or Problem · 0

    ON (B)(6) 2017 A PATIENT RECEIVED A PERCEVAL PVS25, SUTURELESS AORTIC HEART VALVE, AS PART OF A AORTIC VALVE REPLACEMENT. THE MANUFACTURER WAS NOTIFIED THAT ON MARCH 09, 2019 THE VALVE WAS EXPLANTED AND A PERCEVAL PVS21 WAS IMPLANTED. THE EXPLANT OCCURRED AT INSTITUTE (B)(6) AND INVOLVED DR. (B)(4). ON OCTOBER 8TH THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION FROM THE SITE. THE EVENT WAS A RESULT IF ENDOCARDITIS. THERE WERE NO IDENTIFIED DEVICE MALFUNCTIONS. THE DEVICE IS NOT AVAILABLE FOR RETURN OR ANALYSIS. THE CHANGE IN SIZE WAS A RESULT OF A CURED ANNULAR ABSCESS WITH A AUTOLOGUS PERICARDIAL PATCH, THUS REDUCING THE SIZE OF THE ANNULUS. THE PATIENT HAD A GOOD POST OPERATIVE EVOLUTION AND WAS STABLE DURING PROCEDURE.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: DEVICE DISPOSITION PRESENTLY UNKNOWN.

    Description of Event or Problem · 1

    ON (B)(6) 2017 A PATIENT RECEIVED A PERCEVAL PVS25, SUTURELESS AORTIC HEART VALVE, AS PART OF A AORTIC VALVE REPLACEMENT. THE MANUFACTURER WAS NOTIFIED THAT ON (B)(6) 2019 THE VALVE WAS EXPLANTED AND A PERCEVAL PVS21 WAS IMPLANTED. THE EXPLANT OCCURRED AT INSTITUTE (B)(6) AND INVOLVED DR. (B)(6). NO FURTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618072 PERCEVAL SUTURELESS AORTIC HEART VALVE TISSUE HEART VALVE LWR LIVANOVA CANADA CORP. PVS25 00896208000436

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention