BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVEO R DELIVERY SYSTEM

    MDR report key: 11848806 · Received May 19, 2021

    Report

    Report Number
    2025587-2021-01601
    Event Type
    Injury
    Date Received
    May 19, 2021
    Date of Event
    April 20, 2021
    Report Date
    May 19, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: GORLA R, ET AL. IN-HOSPITAL OUTCOMES AND PREDICTORS OF PARAVALVULAR LEAK AND DEEP IMPLANTATION WITH THE EVOLUT-R 34 MM DEVICE: A COMPARISON WITH SMALLER EVOLUT-R SIZES. CARDIOVASC REVASC MED. 2021 APR 20;S1553-8389(21)00184-6. DOI: 10.1016/J.CARREV.2021.03.024. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING THE IN-HOSPITAL PATIENT OUTCOMES WITH THE 34 MM EVOLUT R COMPARED TO SMALLER EVOLUT R VALVES AND TO IDENTIFY PREDICTORS OF PARAVALVULAR LEAK (PVL) AND DEEP IMPLANTATION SPECIFIC TO THE 34 MM EVOLUT R. ALL DATA WAS RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN 2016 AND 2019. THE STUDY POPULATION INCLUDED 359 PATIENTS AND WAS PREDOMINANTLY FEMALE WITH A MEAN AGE OF 83.2 YEARS. ALL PATIENTS UNDERWENT TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH MEDTRONIC EVOLUT R TRANSCATHETER VALVE SYSTEMS. OF THOSE, 84 PATIENTS WERE TREATED WITH 34 MM SIZE VALVES AND 275 PATIENTS WERE TREATED WITH 23, 26, OR 29 MM SIZE VALVES. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, A TOTAL OF 13DEATHS OCCURRED WITHIN THIRTY DAYS OF TAVR. EVOLUT R AND ENVEO R DELIVERY CATHETER SYSTEM MAY HAVE CAUSED OR CONTRIBUTED TO FIVE OF THESE DEATHS (ALL PERIPROCEDURAL). THE CAUSES OF THESE FIVE DEATHS CONSISTED OF LEFT VENTRICLE PERFORATION THAT OCCURRED DURING VALVE SYSTEM PASSAGE THROUGH THE NATIVE AORTIC VALVE (ONE CASE), BOWEL ISCHEMIA (ONE CASE), RETROPERITONEAL HEMORRHAGE (ONE CASE), AND CARDIOGENIC SHOCK (TWO CASES). NONE OF THE OTHER DEATHS WERE ATTRIBUTED TO MEDTRONIC DEVICES. AMONG ALL PATIENTS, NON-DEATH PROCEDURAL ADVERSE EVENTS INCLUDED: VALVE DISLODGEMENT INTO THE LEFT VENTRICLE CAUSING MODERATE TO SEVERE PVL TREATED WITH IMPLANTATION OF A SECOND VALVE, REDUCING PVL TO MILD; PERCUTANEOUS CORONARY INTERVENTION WITH STENTING; VALVE RECAPTURE AND REPOSITIONING; DEEP VALVE IMPLANTATION (DEFINED AS MEAN IMPLANT DEPTH OF = 6 MM); PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WITH STENTING OF ACCESS SITE; POST-DILATION FOR MODERATE TO SEVERE PVL; AND MAJOR VASCULAR COMPLICATIONS. NON-DEATH IN-HOSPITAL ADVERSE EVENTS INCLUDED: PERMANENT PACEMAKER IMPLANTATION; STROKE (INCLUDING NOT DISABLING); MEAN AORTIC GRADIENT GREATER THAN 20 MMHG; AND MILD TO SEVERE PVL. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743586 ENVEO R DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION ENVEOR-L UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention