BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTICO TRANSCATHETER AORTIC VALVE

    MDR report key: 16908452 · Received May 10, 2023

    Report

    Report Number
    2135147-2023-02043
    Event Type
    Injury
    Date Received
    May 10, 2023
    Date of Event
    January 1, 2018
    Report Date
    May 23, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT 422 PATIENTS RECEIVED A NAVITOR/PORTICO VALVE IN THE PERIOD BETWEEN (B)(6) 2018 TO (B)(6) 2021. 345 PATIENTS RECEIVED THE PORTICO VALVE, WHILE 77 RECEIVED THE NAVITOR VALVE. SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF PORTICO VALVE AND NAVITOR VALVE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES, HYPERTENSION, DIABETES MELLITUS, CORONARY ARTERY DISEASE, PRIOR STROKE, CHRONIC RENAL FAILURE, CHRONIC LUNG DISEASE, PRE-EXISTING RIGHT BUNDLE BRANCH BLOCK, ATRIAL FIBRILLATION. SOME OF THE COMPLICATIONS REPORTED WERE POST DILATATION, NEW ONSET OF LEFT BUNDLE BRANCH BLOCK, AND PACEMAKER IMPLANT. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW, AND NO DEVICE OR INDIVIDUAL PATIENT INFORMATION WAS RECEIVED FOR ANALYSIS.

    Additional Manufacturer Narrative · 0

    D4 - THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBERS WERE NOT PROVIDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    THE ARTICLE, "IMPACT OF IMPLANTATION TECHNIQUE ON CONDUCTION DISTURBANCES FOR TAVR WITH THE SELF-EXPANDING PORTICO/NAVITOR VALVE", WAS REVIEWED. THIS ARTICLE IS A RETROSPECTIVE OBSERVATIONAL STUDY TO ASSESS THE IMPACT OF DIFFERENT IMPLANTATION TECHNIQUES ON THE RISK OF PERMANENT PACEMAKER IMPLANTATION (PPMI)FOLLOWING TAVR WITH THE PORTICO/NAVITOR TRANSCATHETER HEART VALVE. THE PORTICO VALVE AND NAVITOR VALVE ARE ASSOCIATED WITH THIS STUDY. THE ARTICLE CONCLUDED THAT THE USE OF A R-L CUSP OVERLAP (RIGHT ANTERIOR OBLIQUE (RAO)-CAUDAL) VIEW FOR IMPLANTATION OF THE PORTICO/NAVITOR VALVE RESULTS IN LESS TILT OF THE NATIVE AORTIC ANNULUS PLANE AND A CLEAR TREND TOWARD A LOWER 30-DAY PPMI RATE AS COMPARED TO TAVR USING THE CONVENTIONAL LEFT ANTERIOR OBLIQUE (LAO) IMPLANTATION VIEW. [THE MAIN AUTHOR AND CORRESPONDING AUTHOR IS LARS SONDERGAARD, MD, DMSC, THE HEART CENTRE, RIGSHOSPITALET, UNIVERSITY OF COPENHAGEN, BLEGDAMSVEJ 9, COPENHAGEN 2100, DENMARK, WITH AN EMAIL: [email protected]] A TOTAL OF 422 PATIENTS RECEIVED A NAVITOR/PORTIVO VALVE IN THE PERIOD BETWEEN JANUARY 2018 TO DECEMBER 2021. THE MEAN AGE WAS 79 YEARS OLD AND THE MAJORITY OF THE PATIENTS WERE FEMALE. COMORBIDITIES INCLUDED HYPERTENSION, DIABETES MELLITUS, CORONARY ARTERY DISEASE, PRIOR STROKE, CHRONIC RENAL FAILURE, CHRONIC LUNG DISEASE, PRE-EXISTING RIGHT BUNDLE BRANCH BLOCK, , ATRIAL FIBRILLATION. 345 PATIENT RECEIVED THE PORTICO VALVE, WHILE 77 PATIENTS RECEIVED THE NAVITOR VALVE. PERI/POST COMPLICATIONS : POST DILATATION, NEW ONSET OF LEFT BUNDLE BRANCH BLOCK, PACEMAKER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881995 PORTICO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention