BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 26MM AORTIC VALVE

    MDR report key: 5831933 · Received July 28, 2016

    Report

    Report Number
    2025587-2016-01161
    Event Type
    Injury
    Date Received
    July 28, 2016
    Date of Event
    January 16, 2011
    Report Date
    July 7, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. CITATION: KENSUKE TAKAGI,1,2,3 MD, AZEEM LATIB,1,2,4 MD, RASHA AL-LAMEE ,1,2 MA, MRCP, MARCO MUSSARDO,1 MD, MATTEO MONTORFANO,1 MD, FRANCESCO MAISANO,5 MD, COSMO GODINO,1,2 MD, ALAIDE CHIEFFO,1 MD, OTTAVIO ALFIE PREDICTORS OF MODERATE-TO-SEVERE PARAVALVULAR AORTIC REGURGITATION IMMEDIATELY AFTER COREVALVE IMPLANTATION AND THE IMPACT OF POSTDILATATION CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 2011: 78:432¿443 THE REVISION ACCEPTED DATE OF 16 JANUARY 2011 WAS USED AS THE EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION, IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED.

    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 VIA LITERATURE REVIEW REGARDING TO INVESTIGATE THE PREDICTORS OF MODERATE-TO-SEVERE PARAVALVULAR LEAK (PVL) FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION AND EVALUATE THE FEASIBILITY AND SAFETY OF POST DILATATION IN REDUCING THE DEGREE OF AR. ALL DATA WAS COLLECTED FROM A SINGLE CENTER BETWEEN (B)(6) 2008 AND (B)(6) 2010. THE STUDY POPULATION INCLUDED 79 PATIENTS, PREDOMINANTLY MALE; MEAN AGE 80 YEARS, ALL OF WHOM WERE IMPLANTED WITH MEDTRONIC COREVALVE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS 3 DEATHS OCCURRED WITHIN 30 DAYS OF IMPLANT AND 7 DEATHS OCCURRED WITHIN THE NEXT 5 MONTHS. THREE DEATHS WERE REPORTED TO BE "CARDIOVASCULAR RELATED", HOWEVER, NONE OF THE DEATHS WERE ATTRIBUTED DIRECTLY TO A MEDTRONIC PRODUCT. CLINICAL FOLLOW-UP WAS ACHIEVED IN 79 PATIENTS (100%) AT 1-MONTH AND 65 PATIENTS AT 6-MONTHS. FOLLOW-UP TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED AT PRE-DISCHARGE, 1 MONTH AND 6 MONTHS, RESPECTIVELY WHERE POSSIBLE. PVL WAS SEEN IN 40.5% (32/79) IMMEDIATELY POST IMPLANT. TWENTY-ONE PATIENTS UNDERWENT POST DILATATION WITH IMPROVEMENT IN PVL GRADE IN THE MAJORITY (17/21). OF THE FOUR PATIENTS WHO DID NOT RESPOND TO POST DILATATION, TWO UNDERWENT VALVE-IN-VALVE IMPLANTATION. IN ONE PATIENT, THE VALVE WAS PULLED MORE PROXIMALLY BY THE SNARE TECHNIQUE. THE REMAINING 10 PATIENTS WERE TREATED CONSERVATIVELY. ONE PATIENT REQUIRED A SECOND TAVI PROCEDURE (VALVE-IN-VALVE) AT 6-MONTHS DUE TO SEVERE PERSISTENT PARAVALVULAR REGURGITATION (PVL). AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: PERMANENT PACEMAKER IMPLANTATION (19), VASCULAR COMPLICATION (NOT SPECIFIED) (16), EMBOLIZATION (4), PATIENT PROSTHESIS MISMATCH (6) AND MYOCARDIAL INFARCTION (1). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481087 COREVALVE 26MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-26-AOA-US

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention