BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 26MM AORTIC VALVE

    MDR report key: 4232313 · Received November 6, 2014

    Report

    Report Number
    2025587-2014-00848
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 14, 2014
    Report Date
    January 27, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND THEREFORE HAS NOT BEEN RETURNED TO MEDTRONIC. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCLUSION: A DEVICE HISTORY REVIEW IS NOT REQUIRED FOR THE VALVE AS THE EVENT DESCRIPTION DOES NOT INDICATE A POTENTIAL MANUFACTURING ISSUE WITH THIS DEVICE. WHILE ATTEMPTING TO DEPLOY THE VALVE, POSITIONING DIFFICULTIES AND A DISLODGEMENT OF THE VALVE WAS EXPERIENCED. POTENTIAL FACTORS THAT CAN INFLUENCE THESE EVENTS INCLUDE TENSION APPLIED ON THE DELIVERY CATHETER SYSTEM DURING POSITIONING, CALCIFICATION LEVELS IN THE NATIVE VESSEL, COMPLIANCE OF THE AORTA AND NATIVE VESSELS, AND A NUMBER OF OTHERS. BASED ON EVENT DESCRIPTION, IT APPEARS THAT THE PROCEDURAL TECHNIQUE COULD HAVE BEEN A CONTRIBUTING FACTOR; HOWEVER, A ROOT CAUSE COULD NOT BE ESTABLISHED FROM THE LIMITED INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC HEART VALVE INTO AN EXISTING REPLACEMENT BIOPROSTHETIC AORTIC VALVE, THIS VALVE MOVED INTO A DEEP POSITION DURING DEPLOYMENT. AS TRACTION WAS APPLIED TO THE DELIVERY CATHETER SYSTEM (DCS) THIS VALVE DISLODGED ABOVE THE AORTIC ROOT. AN ATTEMPT TO RETRIEVE THE VALVE INTO THE INTRODUCER SHEATH WAS UNSUCCESSFUL, AND THE VALVE RELEASED FROM THE DCS DURING THE ATTEMPT. THE VALVE WAS LEFT IMPLANTED IN THE ABDOMINAL AORTA. A SECOND VALVE OF THE SAME MODEL AND TYPE SUBSEQUENTLY WAS IMPLANTED IN A DEEP POSITION WITH AN OBSERVATION OF MODERATE PARAVALVULAR LEAK. THERE WAS NO ADDITIONAL INTERVENTION. NO SUBSEQUENT ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713715 COREVALVE 26MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-26-AOA

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Other| R DCS-C4-18FR, 0007091908