BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 26MM AORTIC VALVE

    MDR report key: 3875322 · Received June 16, 2014

    Report

    Report Number
    2025587-2014-00392
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 22, 2014
    Report Date
    January 7, 2015
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED INFORMATION DID NOT INDICATE A POTENTIAL MANUFACTURING ISSUE. VARIOUS FACTORS CAN AFFECT VALVE POSITIONING, SUCH AS PATIENT ANATOMY OR PHYSICIAN EXPERIENCE. IN THIS CASE, THE POSITIONING ISSUES WERE REPORTED TO BE DUE TO THE PATIENT¿S SEPTAL BULGE THAT WAS PROTRUDING INTO THE LEFT VENTRICULAR OUTFLOW TRACT. POTENTIAL FACTORS FOR A DISLODGED VALVE INCLUDE INADEQUATE DEPLOYMENT (DUE TO IMPROPER SIZING BETWEEN VALVE AND ANNULUS, IRREGULAR PATIENT ANATOMY, OR INCOMPLETE FRAME EXPANSION) AND INCOMPLETE DETACHMENT OF THE VALVE FROM THE DCS. IN THIS CASE, THE SEPTAL BULGE MAY HAVE BEEN A CONTRIBUTING FACTOR; HOWEVER, A CONCLUSIVE CAUSE OF THE DISLODGEMENT COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. AORTIC INSUFFICIENCY (REGURGITATION) CAN BE CAUSED BY A VARIETY OF FACTORS, INCLUDING VALVE POSITIONING, PATIENT ANATOMY, OR THE PRESENCE OF PRE-EXISTING PATIENT CONDITIONS, AND A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE. A MILD AORTIC REGURGITATION HAS MINIMAL IMPACT ON THE PATIENT AND IS GENERALLY DEEMED AN ACCEPTABLE RESIDUAL CONDITION. HYPOTENSION IS A KNOWN POTENTIAL ADVERSE EFFECT PER THE COREVALVE INSTRUCTIONS FOR USE (IFU). IT IS AN EFFECT THAT IS HIGHLY DEPENDENT ON THE PATIENT'S PRE-PROCEDURAL CONDITION AND CAN OCCUR DESPITE A NORMALLY-FUNCTIONING DEVICE OR MODEL IMPLANT PROCEDURE. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE HYPOTENSION APPEARS TO BE DUE TO THE LMA OCCLUSION. THE OCCLUSION WAS DETERMINED TO BE CAUSED BY THE LEAFLETS FROM THE FIRST IMPLANTED VALVE. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. GENERALLY, THIS ISSUE IS DUE TO PATIENT ANATOMY AND/OR IMPLANT TECHNIQUE AND DOES NOT INDICATE A DEVICE FAILURE OR MALFUNCTION. IN THIS CASE, IT MAY HAVE OCCURRED DUE TO THE SEPTAL BULGE AND/OR THE IMPLANT OF THE SECOND VALVE. HOWEVER, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. CONDUCTION DISTURBANCES, SUCH AS VENTRICULAR FIBRILLATION, ARE KNOWN POTENTIAL ADVERSE EFFECTS PER THE COREVALVE IFU.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE VALVE REMAINS IMPLANTED AND THEREFORE HAS NOT BEEN RETURNED TO MEDTRONIC. THE ASSOCIATED DELIVERY CATHETER SYSTEM (DCS) WAS DISCARDED BY THE IMPLANTING FACILITY STAFF. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, A PROMINENT SEPTAL BULGE IN THE LEFT VENTRICLE MADE POSITIONING THE VALVE DIFFICULT. AS THE VALVE WAS BEING DEPLOYED, IT MOVED OUT OF THE TARGETED LOCATION IN THE ANNULUS. DUE TO THE ANATOMY AND THE ACCESS METHOD, THE VALVE WAS UNABLE TO BE RETRIEVED. AFTER THE CORONARY ARTERIES WERE DETERMINED TO BE PATENT AND SAFE FROM OCCLUSION, THE VALVE WAS ABANDONED IN THE SINUS OF VALSALVA. A SECOND VALVE WAS SUCCESSFULLY IMPLANTED AND PATENT CORONARY ARTERIES WERE OBSERVED. AFTER A FEW MINUTES, HYPOTENSION WAS NOTED, AND A SECOND AORTOGRAM REVEALED THE LEFT MAIN CORONARY ARTERY (LMA) TO BE COMPLETELY OCCLUDED BY THIS VALVE. CARDIOPULMONARY BYPASS WAS INITIATED, STABILIZING THE PATIENT. A WIRE WAS PLACED AND THE LMA WAS OPENED USING BALLOON ANGIOPLASTY. IT WAS CONFIRMED THERE WAS NO OCCLUSION IN THE RIGHT CORONARY ARTERY (RCA). AT THIS TIME, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION. AFTER MULTIPLE SHOCKS, THE PATIENT RETURNED TO A SINUS RHYTHM AND WAS REMOVED FROM BYPASS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352712 COREVALVE 26MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT HEART VALVES SANTA ANA MCS-P3-26-AOA

    Patients

    Seq Age Sex Outcome Treatment
    1 00091 YR Required Intervention (B)(4)