BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE

    MDR report key: 4124061 · Received September 27, 2014

    Report

    Report Number
    2025587-2014-00705
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    June 3, 2014
    Report Date
    May 12, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE RELATIONSHIP BETWEEN THE DURATION OF IMPLANT AND THE INCIDENCE OF STROKE CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED; HOWEVER, STROKE IT IS A KNOWN POTENTIAL ADVERSE EFFECT PER COREVALVE INSTRUCTIONS FOR USE (IFU). A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FROM THE LIMITED INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

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

    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)

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT 14 MONTHS POST IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE THE PATIENT PRESENTED WITH SYMPTOMS OF LEFT-SIDED WEAKNESS, CONFUSION, AND LETHARGY. THE PATIENT HAD A MAGNETIC RESONANCE ANGIOGRAM (MRA) WHICH SHOWED LUMINAL IRREGULARITY WITH MODERATE SEGMENTAL STENOSIS OF THE LEFT GREATER THAN RIGHT INTRACRANIAL INTERNAL CAROTID ARTERIES PREDOMINANTLY INVOLVING THE CAVERNOUS SEGMENT. AN MAGNETIC RESONANCE IMAGING (MRI) SHOWED A FEW FOCI OF T2 SIGNAL ABNORMALITY PREDOMINANTLY IN PERIVENTRICULAR WHITE MATTER BILATERALLY. THERE WAS NO ACUTE INFARCTION, HEMORRHAGE OR MASS NOTED. AN INTERNAL REVIEW OF THE MAGNETIC RESONANCE IMAGING (MRI) REVEALED A RECENT STROKE. THE PHYSICIAN FELT THAT THE DEVICE POSSIBLY COULD HAVE CONTRIBUTED TO THE STROKE. THE DEVICE REMAINS IMPLANTED AND THE PATIENT CONTINUES TO BE MONITORED. NO FURTHER ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603691 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-943

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization