BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE

    MDR report key: 6107428 · Received November 16, 2016

    Report

    Report Number
    2025587-2016-01810
    Event Type
    Injury
    Date Received
    November 16, 2016
    Date of Event
    April 1, 2014
    Report Date
    November 14, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: YU HP <(>&<)> YIN WH. AN OLD MAN NEEDED 3 STENT GRAFTS TO FIX CRITICAL AORTIC STENOSIS AND TRANSSUBCLAVIAN VASCULAR ACCESS COMPLICATION. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY. 2014; VOLUME 63, ISSUE 12, PAGES S210. UNIQUE DEVICE IDENTIFIER (SERIAL) NUMBERS WERE PROVIDED; A REVIEW MEDTRONIC'S GLOBAL COMPLAINT HANDLING DATABASE FOUND NO PREVIOUS RECORDS OR SUBMITTED REPORTS.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING AN (B)(6) YEAR-OLD MALE PATIENT WITH SEVERE SYMPTOMATIC AORTIC STENOSIS AND MODERATE AORTIC REGURGITATION. THE PATIENT UNDERWENT IMPLANT OF A MEDTRONIC 29-MM COREVALVE (SERIAL NUMBER NOT PROVIDED) IN THE AORTIC POSITION THROUGH THE LEFT SUBCLAVIAN ARTERY USING A 18 FRENCH NON-MEDTRONIC SHEATH. UPON PARTIAL DEPLOYMENT THE VALVE POSITION WAS NOTED AS TOO DEEP, AND WAS SUBSEQUENTLY PULLED BACK FROM THE AORTIC ANNULUS INTO THE ASCENDING AORTA, RESHEATHED, AND WITHDRAWN FROM THE BODY. A SECOND VALVE WAS SUCCESSFULLY DEPLOYED WITH GOOD POSITION, RESULTING IN AN ACCEPTABLE MILD PARAVALVULAR LEAK. AFTER REMOVAL OF THE 18F NON-MEDTRONIC SHEATH, A LARGE DISSECTION FLAP WAS SEEN IN THE LEFT SUBCLAVIAN ARTERY. DURING ATTEMPTED REPAIR, THE LEFT SUBCLAVIAN ARTERY WAS TRANSECTED, WHICH WAS SUBSEQUENTLY RESOLVED WITH PLACEMENT OF A NON-MEDTRONIC STENT TO CONNECT THE PROXIMAL AND DISTAL PORTIONS OF THE ARTERY. AFTER STENT PLACEMENT ANGIOGRAPHY SHOWED GOOD DISTAL FLOW AND NO LEAKAGE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION FROM THE PHYSICIAN/AUTHOR PROVIDED THE VALVE SERIAL NUMBERS (1ST: B084808, 2ND: B102650) AND THE PATIENT'S WEIGHT ((B)(6)), AND ALSO STATED THAT THE FIRST VALVE CAUSED THE LEFT SUBCLAVIAN ARTERY DISSECTION DURING THE RETRIEVAL FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757112 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-640

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening| R