BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 31MM AORTIC VALVE

    MDR report key: 3963463 · Received July 29, 2014

    Report

    Report Number
    2025587-2014-00529
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 7, 2014
    Report Date
    December 17, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND THEREFORE HAS NOT BEEN RETURNED TO MEDTRONIC. 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. THE REPORTED INFORMATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING ISSUE. AORTIC INSUFFICIENCY (AI) CAN BE CAUSED BY A NUMBER OF FACTORS, INCLUDING VALVE POSITIONING, PATIENT ANATOMY, OR THE PRESENCE OF PRE-EXISTING PATIENT CONDITIONS. IN THIS CASE, PATIENT ANATOMY/EXISTING CALCIFICATION MOST LIKELY CONTRIBUTED TO THE ISSUE; HOWEVER, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE. A SECOND VALVE WAS IMPLANTED SUCCESSFULLY WITH MILD AI; A MILD AI HAS MINIMAL IMPACT ON THE PATIENT AND IS GENERALLY DEEMED AN ACCEPTABLE RESIDUAL CONDITION.

    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 THIS TRANSCATHETER BIOPROSTHETIC VALVE WAS DEPLOYED AT ITS TARGETED LOCATION BUT DID NOT FULLY EXPAND DUE TO EXISTING CALCIFICATION WITHIN THE AORTA, RESULTING IN MODERATE TO SEVERE AORTIC INSUFFICIENCY. POST-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) WAS USED TO FURTHER EXPAND THE VALVE; DURING THE BAV, THE VALVE DISLODGED OUT OF THE ANNULUS. IT WAS THEN SNARED AND PULLED INTO THE ASCENDING AORTA. THERE WERE NO NOTED PATIENT COMPLICATIONS. A SECOND VALVE WAS THEN SUCCESSFULLY IMPLANTED WITH MILD AORTIC INSUFFICIENCY. THERE WAS NO FURTHER INTERVENTION AND NO SUBSEQUENT ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442087 COREVALVE 31MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-31-AOA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention