BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 31MM AORTIC VALVE

    MDR report key: 3800123 · Received May 8, 2014

    Report

    Report Number
    2025587-2014-00270
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    February 3, 2014
    Report Date
    April 16, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE PRODUCT REMAINS IMPLANTED, THEREFORE, NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: PER THE INSTRUCTIONS FOR USE (IFU), CONDUCTION DISTURBANCES ARE A POTENTIAL PROCEDURAL COMPLICATION AND ARE ASSOCIATED WITH ANY CARDIAC OR THORACIC PROCEDURE, OPEN OR CATHETER-BASED, AND CAN BE RESOLVED WITH MEDICAL TREATMENT OR THE IMPLANT OF A PERMANENT PACEMAKER. ACCORDING TO LITERATURE REVIEW AND THE VALVE (B)(4), THE CLOSE ANATOMICAL RELATIONSHIP BETWEEN THE AORTIC VALVE COMPLEX AND THE BRANCHING ATRIOVENTRICULAR BUNDLE MAY PROVIDE AN EXPLANATION FOR THESE COMPLICATIONS OF THE PROCEDURE. OTHER FACTORS THAT COULD CONTRIBUTE TO THE ONSET OF CONDUCTION DEFECTS INCLUDE UNDERLYING HEART DISEASE, ELECTROLYTE DISTURBANCES AND CERTAIN MEDICATIONS (I.E. BETA BLOCKERS, CALCIUM CHANNEL BLOCKERS). IN THIS CASE, THE EXACT CAUSE OF THE REPORTED CLINICAL OBSERVATION CANNOT BE CONFIRMED, HOWEVER, MAY BE RELATED TO THE PATIENT'S PRE-EXISTING CONDUCTION DISTURBANCES. (B)(6). (B)(4).

    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 THREE DAYS FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE PATIENT DEVELOPED TRANSIENT HEART BLOCK. SUBSEQUENTLY A PERMANENT PACEMAKER WAS IMPLANTED WITH NO ADVERSE PATIENT EFFECTS. IT WAS REPORTED THAT THE PATIENT HAD HISTORY OF FIRST-DEGREE AV BLOCK, RIGHT BUNDLE BRANCH BLOCK, AND SYNCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279548 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 00082 YR Required Intervention