BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE

    MDR report key: 3656036 · Received March 3, 2014

    Report

    Report Number
    2025587-2014-00087
    Event Type
    Injury
    Date Received
    March 3, 2014
    Date of Event
    February 4, 2014
    Report Date
    July 3, 2017
    Manufacturer
    MEDTRONIC COREVALVE, LLC
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PATIENT WAS REFERRED FOR A SURGICAL CONSULTATION DUE TO INCREASED AORTIC GRADIENT MEASUREMENTS ONE MONTH POST-IMPLANT. NO INTERVENTION HAS BEEN PERFORMED TO DATE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS VALVE WAS SURGICALLY EXPLANTED APPROXIMATELY 1.5 MONTHS AFTER IMPLANT DUE TO THE INCREASED GRADIENTS. ANOTHER MANUFACTURER¿S VALVE WAS IMPLANTED WITH NO SUBSEQUENT ADVERSE PATIENT EFFECTS BEYOND THE REOPERATION. DEVICE RETURN HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED OR IF THE DEVICE IS RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED IT TO BE IN A 10% FORMALIN SOLUTION IN A SPECIMEN CONTAINER, PLACED IN AN EXPLANT KIT. ALL LEAFLETS WERE PARTIALLY OPEN AT THE POINT OF COAPTATION. ALL LEAFLETS WERE SLIGHTLY STIFF BUT FLEXIBLE, POSSIBLY DUE TO IMPLANT DURATION, BLOOD CONTACT AND/OR THE DECONTAMINATION PROCESS. ALL LEAFLETS WERE INTACT. ALL COMMISSURES WERE INTACT. TWO SMALL CLUSTERS OF TAN THROMBOTIC-APPEARING HOST TISSUE REMAINED ATTACHED TO THE ONE LEAFLET ON THE OUTFLOW. RADIOGRAPHY SHOWED NO EVIDENCE OF MINERALIZATION IN THE VALVE. RADIOGRAPHY SHOWED NO EVIDENCE OF FRAME FRACTURES. THE INVESTIGATION IS STILL IN PROGRESS; A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE ORIGINAL DISCHARGE ECHOCARDIOGRAM NOTED MODERATE PARAVALVULAR LEAK (PVL) HAD BEEN PRESENT. AS PREVIOUSLY REPORTED BOTH TRANSCATHETER VALVES WERE EXPLANTED DUE TO HIGH GRADIENT MEASUREMENTS AND REPLACED WITH ANOTHER MANUFACTURERS VALVE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PRODUCT REMAINS IMPLANTED AND THEREFORE HAS NOT BEEN RETURNED TO MEDTRONIC. THE INVESTIGATION IS CONTINUING; A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. THE AMOUNT AND LOCATION OF THROMBOTIC HOST TISSUE GAVE NO INDICATION IT CONTRIBUTED TO A GRADIENT. POST-IMPLANT GRADIENTS ARE OFTEN RELATED TO STENOSIS, AND A SMALL GRADIENT, INDICATIVE OF MILD STENOSIS, IS GENERALLY A CLINICALLY-ACCEPTABLE RESIDUAL CONDITION UNLESS THE PATIENT IS SYMPTOMATIC. IT IS KNOWN THAT IMPLANT OF A COREVALVE INSIDE ANOTHER DEVICE CAUSES A DECREASE IN EFFECTIVE ORIFICE AREA (EOA) DUE TO THE SIZE AND THICKNESS OF THE VALVE FRAME, AND THE PRESENCE OF SLIGHT TRANSVALVULAR GRADIENTS IS ANTICIPATED IN THAT SITUATION. IT HAS BEEN SHOWN THAT MOST PROSTHETIC VALVES ARE AT LEAST MILDLY STENOTIC AND THAT GRADIENTS CAN BE OBSERVED DESPITE NORMAL DEVICE FUNCTIONALITY. IN ADDITION, THE PRESENCE OF PRE-EXISTING STENOSIS POTENTIALLY DIMINISHED THE MAXIMUM EOA OF THE IMPLANTED COREVALVE DEVICE.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE INTO A NON-MEDTRONIC BIOPROSTHETIC VALVE (DUE TO AN OBSERVATION OF HIGH GRADIENTS), THE PATIENT EXHIBITED LEFT BUNDLE BRANCH BLOCK, WHICH WAS TREATED WITH A TRANSVENOUS PACEMAKER IMPLANT, AND A SMALL GRADIENT MEASUREMENT, WHICH WAS RESOLVED WITH A POST-IMPLANT VALVULOPLASTY. NO SUBSEQUENT ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126615 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC COREVALVE, LLC MCS-P3-640

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention