BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 29MM AORTIC VALVE

    MDR report key: 3952898 · Received July 23, 2014

    Report

    Report Number
    2025587-2014-00515
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 1, 2014
    Report Date
    December 22, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    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

    A SEPARATE MEDWATCH REPORT HAS BEEN FILED ON THE FIRST VALVE. 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

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

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY REVIEW FOR THIS VALVE IS NOT REQUIRED AS THE EVENT DESCRIPTION DOES NOT INDICATE A POTENTIAL MANUFACTURING ISSUE. NO ALLEGATIONS WERE MADE AGAINST THE DEVICES. THE PHYSICIAN BELIEVED THAT THE DISLODGMENTS OF THE VALVES WERE DUE TO THE LACK OF CALCIFICATION IN THE ANNULUS AREA; HOWEVER, CALCIFICATION IN THE ANNULUS AREA IS NOT A REQUIREMENT FOR THE VALVE IMPLANT PER THE INSTRUCTIONS FOR USE. POTENTIAL FACTORS FOR DISLODGEMENT INCLUDE INADEQUATE DEPLOYMENT, IMPROPER SIZING BETWEEN VALVE AND ANNULUS, IRREGULAR PATIENT ANATOMY, INCOMPLETE FRAME EXPANSION, IMPLANT TECHNIQUE, PHYSICIAN EXPERIENCE, ETC. THE DEVICES REMAIN IMPLANTED. A CONCLUSIVE CAUSE FOR THESE DISLODGEMENT EVENTS WAS UNABLE TO BE DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT TWO ATTEMPTED IMPLANTS OF TRANSCATHETER BIOPROSTHETIC HEART VALVES WERE UNSUCCESSFUL AFTER THE VALVES DISLODGED FROM THEIR TARGET LOCATIONS DUE TO A LACK OF CALCIFICATION IN THE PATIENT ANATOMY. IT WAS REPORTED THAT THIS VALVE WAS THE SECOND VALVE IMPLANT ATTEMPTED AFTER DISLODGEMENT OF THE FIRST VALVE. THIS VALVE WAS POSITIONED IN ITS TARGET LOCATION, BUT DISLODGED AS IT WAS ONE-THIRD DEPLOYED. THE VALVE WAS RETRIEVED TO THE ABDOMINAL AORTA, WHERE AN ATTEMPT TO RETRIEVE IT INTO THE INTRODUCER SHEATH WAS UNSUCCESSFUL. THE VALVE WAS THEN DEPLOYED IN THE ABDOMINAL AORTA; AN ABDOMINAL AORTOGRAM WAS PERFORMED AND CONFIRMED THAT THE RENAL ARTERIES AND SUPERIOR MESENTERIC ARTERY WERE NOT COMPROMISED. THERE WAS NO REPLACEMENT VALVE IMPLANTED, AND NO CHANGE IN THE PATIENT¿S AORTIC INSUFFICIENCY AS A RESULT OF THE IMPLANT ATTEMPTS. NO SUBSEQUENT ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430531 COREVALVE 29MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-29-AOA

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Required Intervention