BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE

    MDR report key: 3656019 · Received March 3, 2014

    Report

    Report Number
    2025587-2014-00086
    Event Type
    Injury
    Date Received
    March 3, 2014
    Date of Event
    February 4, 2014
    Report Date
    July 7, 2014
    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

    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

    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.

    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. PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, VISUAL INSPECTION REVEALED THE RETURNED DEVICE TO BE IN A CLEAR SOLUTION IN THE ORIGINAL PRODUCT PACKAGING. ALL LEAFLETS WERE IN A FULLY OPEN POSITION, RESTING AGAINST THE FRAME, DUE TO A VALVE-IN-VALVE IMPLANT. ALL LEAFLETS WERE SLIGHTLY STIFF BUT FLEXIBLE, POSSIBLY DUE TO BLOOD CONTACT DURATION AND/OR THE DECONTAMINATION PROCESS. ALL LEAFLETS WERE INTACT. ALL COMMISSURES WERE INTACT. REMNANTS OF PANNUS REMAINED ATTACHED ALONG THE FRAME AND SKIRT. PANNUS EXTENDED TO ONE COMMISSURE. THE INVESTIGATION IS STILL IN PROGRESS; A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: THIS DEVICE, WHICH HAD BEEN ABANDONED AFTER IT POPPED OUT OF POSITION DURING ITS ATTEMPTED IMPLANT, WAS SUBSEQUENTLY CONCOMITANTLY EXPLANTED SURGICALLY WITH THE DEVICE IN MAUDE REPORT 2025587-2014-00087. ALSO, THE CORRECT AWARE DATE FOR THE PREVIOUS SUPPLEMENTAL REPORT WAS (B)(6) 2014. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO MANUFACTURING ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. THERE WERE NO ANOMALIES NOTED IN THE ANALYSIS OF THE RETURNED VALVE THAT EXPLAIN THE POSITIONING DIFFICULTIES EXPERIENCED BY THE USER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE INTO A NON-MEDTRONIC BIOPROSTHETIC VALVE (DUE TO AN OBSERVATION OF HIGH GRADIENTS), UPON FULL RELEASE FROM THE DELIVERY CATHETER SYSTEM THE VALVE POPPED OUT OF THE ANNULUS AND WAS ABANDONED AT A LOCATION FOUR CENTIMETERS SUPRA-ANNULAR. ANOTHER VALVE OF THIS SAME MODEL AND SIZE WAS SUCCESSFULLY IMPLANTED VALVE-IN-VALVE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125601 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC COREVALVE, LLC MCS-P3-640

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention