BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE

    MDR report key: 5002119 · Received August 13, 2015

    Report

    Report Number
    2025587-2015-00860
    Event Type
    Injury
    Date Received
    August 13, 2015
    Date of Event
    April 25, 2015
    Report Date
    August 25, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE: MANAGEMENT STRATEGIES FOR ACUTE CORONARY OCCLUSION ASSOCIATED WITH COREVALVE TRANSCATHETER AORTIC VALVE REPLACEMENT AUTHORS: SREEDIVYA CHAVA, EDWARD TERRIEN, JOSEPH SCHMOKER, MARC TISCHLER, HAROLD L. DAUERMAN CITATION: J THROMB THROMBOLYSIS (2015) 40:198¿202 (DOI 10.1007/S11239-015-1222-6) DATE OF PUBLISH USED FOR EVENT DATE.

    Additional Manufacturer Narrative · 1

    A SEARCH OF THE MEDTRONIC COMPLAINT HANDLING DATABASE WITH THE NEWLY RECEIVED MODEL/SERIAL INFORMATION REVEALED THIS EVENT WAS PREVIOUSLY REPORTED TO FDA VIA REPORT # 2025587-2014-00698. THE INVESTIGATION IS CURRENTLY PENDING, ONCE INVESTIGATION IS COMPLETE A SUMMARY OF THIS EVENT WILL BE HANDLED WITH A SUPPLEMENTAL REPORT UNDER THIS NUMBER.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW OF ACUTE CORONARY ARTERY OCCLUSION SUBSEQUENT TO MEDTRONIC TRANSCATHETER BIOPROSTHETIC VALVE IMPLANTATION. A (B)(6) FEMALE PATIENT WITH SEVERE AORTIC STENOSIS AND PROGRESSIVELY WORSENING EXERTIONAL DYSPNEA UNDERWENT SUCCESSFUL IMPLANT OF A MEDTRONIC 26-MM TRANSCATHETER BIOPROSTHETIC VALVE (SERIAL NOT REPORTED). IMMEDIATE POST-IMPLANT MEASURES SHOWED NEGLIGIBLE PRESSURE GRADIENTS ACROSS THE AORTIC VALVE AND MILD PERIVALVULAR REGURGITATION. DURING CLOSURE OF THE FEMORAL ACCESS SITE, HYPOTENSION WITH EVIDENCE OF SEVERE DIFFUSE LEFT VENTRICLE HYPOKINESIS WAS NOTED. AN ANGIOGRAPHY REVEALED OCCLUSION OF THE LEFT MAIN CORONARY ARTERY (LMCA) OSTIUM BY A DISPLACED NATIVE AORTIC VALVE LEAFLET. THE BIOPROSTHETIC VALVE WAS SNARED AND PULLED UP TO THE SINOTUBULAR JUNCTION, RESULTING IN RESTORATION OF CORONARY FLOW AND RECOVERY OF LEFT VENTRICULAR SYSTOLIC FUNCTION. AN ECHOCARDIOGRAM ONE WEEK POST-OPERATIVE REVEALED PRESSURE GRADIENTS CONSISTENT WITH MODERATE AORTIC STENOSIS. AT SIX MONTHS POST-OPERATIVE, SEVERE SYMPTOMATIC AORTIC STENOSIS RECURRED AND THE PATIENT UNDERWENT HIGH RISK SURGICAL AORTIC VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED, AND NO FURTHER DETAILS WERE PROVIDED REGARDING THE SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION IDENTIFIED THE BIOPROSTHETIC VALVE AS MODEL MCS-P3-640 AND SERIAL (B)(4), WHICH WAS EXPLANTED AND SURGICALLY REPLACED BY A NON-MEDTRONIC BIOPROSTHETIC VALVE WITH GOOD CLINICAL OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533855 COREVALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-640

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention