BEUDAMED
    FDA Adverse Event Death Summary report: N

    EPIC MAX VALVE (AORTIC)

    MDR report key: 18852506 · Received March 6, 2024

    Report

    Report Number
    2135147-2024-01029
    Event Type
    Death
    Date Received
    March 6, 2024
    Date of Event
    February 9, 2024
    Report Date
    May 22, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LWR
    UDI-DI
    05415067045447
    PMA / PMN Number
    P040021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    AN EVENT OF DIFFICULTY IMPLANTING THE VALVE AND PATIENT DEATH WAS REPORTED. A RETURNED DEVICE ASSESSMENT INCLUDING A DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED AS DEVICE REMAINED IMPLANTED AND WAS NOT RETURNED FOR ANALYSIS. IT WAS NOTED THAT THE AORTA WAS REPAIRED WITH A PATCH DURING IMPLANT. ADDITIONALLY HAD DIFFICULTY SEPARATING FROM CARDIOPULMONARY BYPASS SO AN INTERNAL MAMMARY ARTERY WAS TAKEN AND BYPASSED TO THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. ABBOTT ALSO REQUESTED FOR INTRA-PROCEDURE IMAGING SUCH AS FLUOROSCOPY WHICH WAS NOT PROVIDED BY THE FIELD. BASED ON THE INFORMATION PROVIDED ,MOST LIKELY IT IS SUSPECTED THAT THE LARGE VALVE SIZE FOR THE ENCOUNTERED ANATOMY MAY HAVE INTERFERED WITH BLOOD FLOW TO THE CORONARY OSTIA AND NECESSITATED THE BYPASS GRAFTING PERFORMED. HOWEVER, THIS CANNOT BE CONFIRMED FOR CERTAIN SUCH THAT THE EXACT CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE. AS PER IFU, PROPER VALVE SIZE SELECTION USING THE REPLICA END OF THE SIZER IS CRITICAL. DO NOT OVERSIZE THE VALVE. IF THE VALVE REPLICA END CANNOT BE EASILY INSERTED INTO THE SINOTUBULAR SPACE AND COMFORTABLY SEATED ON TOP OF THE ANNULUS, USE A SMALLER SIZE EPIC¿ MAX VALVE." FOR THIS CASE IT IS CONCEIVABLE THAT THE AORTIC PATCH PERFORMED MAY HAVE CREATED MORE SPACE IN THE AORTIC ROOT TO ACCOMMODATE THE 21 MM EPIC¿ MAX VALVE. HOWEVER, BASED ON THE ENCOUNTERED OUTCOME IT IS POSSIBLE THAT THE PATCH ALONE MAY NOT HAVE BEEN SUFFICIENT TO ACCOMMODATE THE IMPLANTED VALVE SIZE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, A 21MM EPIC MAX VALVE WAS CHOSEN FOR IMPLANT IN A 77-YEAR-OLD WOMAN. DURING THE PROCEDURE, IT WAS NOTED THAT THE CORRESPONDING 21MM EPIC MAX REPLICA END OF THE SIZER WAS DIFFICULT TO PASS THROUGH THE SINOTUBULAR JUNCTION (STJ) AND IN THE PROCESS OF FORCING THE SIZER THROUGH THE STJ THERE WAS AN INJURY CAUSED TO THE AORTA. DESPITE THE DIFFICULTIES IN PASSING THE 21MM EPIC MAX REPLICA END OF THE SIZER THROUGH THE STJ THE PHYSICIAN DECIDED TO IMPLANT AN EPIC MAX 21MM VALVE. THE PHYSICIAN HAD DIFFICULTY SEATING THE EPIC MAX 21MM VALVE ON TOP OF THE ANNULUS AND HAD TO PATCH THE AORTA TO FIT THE VALVE. WHEN THE PATIENT WAS TAKEN OFF CARDIOPULMONARY BYPASS, THERE WERE CONCERNS ABOUT A BLOCKED RIGHT CORONARY ARTERY, SO A SAPHENOUS VEIN GRAFT WAS TAKEN AND BYPASSED TO THE RIGHT CORONARY ARTERY. THERE CONTINUED TO BE DIFFICULTY SEPARATING FROM CARDIOPULMONARY BYPASS SO AN INTERNAL MAMMARY ARTERY WAS TAKEN AND BYPASSED TO THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE PATIENT CONTINUED TO HAVE DIFFICULTY SEPARATING FROM CARDIOPULMONARY BYPASS, SO SHE WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND TRANSFERRED TO CARDIOVASCULAR INTENSIVE CARE UNIT (CVICU). HOWEVER, SEVERAL DAYS LATER THE PATIENT PASSED AWAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, A 21MM EPIC MAX VALVE WAS CHOSEN FOR IMPLANT. DURING THE PROCEDURE, IT WAS NOTED THAT THE CORRESPONDING 21MM EPIC MAX REPLICA END OF THE SIZER WAS DIFFICULT TO PASS THROUGH THE SINOTUBULAR JUNCTION (STJ) AND IN THE PROCESS OF FORCING THE SIZER THROUGH THE STJ, THERE WAS AN INJURY CAUSED TO THE AORTA. DESPITE THE DIFFICULTIES IN PASSING THE 21MM EPIC MAX REPLICA END OF THE SIZER THROUGH THE STJ, THE PHYSICIAN DECIDED TO IMPLANT AN EPIC MAX 21MM VALVE. THE PHYSICIAN HAD DIFFICULTY SEATING THE EPIC MAX 21MM VALVE ON TOP OF THE ANNULUS AND HAD TO PATCH THE AORTA TO FIT THE VALVE. WHEN THE PATIENT WAS TAKEN OFF CARDIOPULMONARY BYPASS, THERE WERE CONCERNS ABOUT A BLOCKED RIGHT CORONARY ARTERY, SO A SAPHENOUS VEIN GRAFT WAS TAKEN AND BYPASSED TO THE RIGHT CORONARY ARTERY. THERE CONTINUED TO BE DIFFICULTY SEPARATING FROM CARDIOPULMONARY BYPASS SO AN INTERNAL MAMMARY ARTERY WAS TAKEN AND BYPASSED TO THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE PATIENT CONTINUED TO HAVE DIFFICULTY SEPARATING FROM CARDIOPULMONARY BYPASS, SO THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND TRANSFERRED TO CARDIOVASCULAR INTENSIVE CARE UNIT (CVICU). HOWEVER, SEVERAL DAYS LATER THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144651 EPIC MAX VALVE (AORTIC) HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ABBOTT MEDICAL BR00040205 05415067045447

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Death