BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTICO TRANSCATHETER AORTIC VALVE

    MDR report key: 23206351 · Received October 2, 2025

    Report

    Report Number
    2135147-2025-05615
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Date of Event
    January 1, 2020
    Report Date
    October 2, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    PMA / PMN Number
    P190023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF PORTICO VALVE WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING CHRONIC KIDNEY DISEASE AND HEART FAILURE. COMPLICATIONS REPORTED INCLUDED SURGICAL INTERVENTION (PACEMAKER, CONVERSION), HOSPITALIZATION, STROKE, TRANSIENT ISCHEMIC ATTACK, RENAL FAILURE, BLEEDING, HEART FAILURE, PERFORATION, OCCLUSION, VASCULAR DISSECTION, AND VALVE MIGRATION; THESE COMPLICATIONS ARE ANTICIPATED FOR THE PROCEDURE AND SUBJECT POPULATION. 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. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURING, DESIGN, OR LABELING. B3: DATE OF EVENT IS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. LITERATURE REVIEW: CONDITIONAL 1-YEAR OUTCOMES AFTER EMERGENT CONVERSION TO OPEN HEART SURGERY DURING TRANSCATHETER AORTIC VALVE IMPLANTATION: A PROPENSITY-MATCHED LANDMARK ANALYSIS.

    Description of Event or Problem · 0

    THE ARTICLE, "CONDITIONAL 1-YEAR OUTCOMES AFTER EMERGENT CONVERSION TO OPEN HEART SURGERY DURING TRANSCATHETER AORTIC VALVE IMPLANTATION: A PROPENSITYMATCHED LANDMARK ANALYSIS", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, MULTICENTER STUDY TO ASSESS 1-YEAR CONDITIONAL OUTCOMES IN PATIENTS WHO SURVIVED =30 DAYS POST-TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI), COMPARING EMERGENT CONVERSION TO OPEN HEART SURGERY (E-OHS) SURVIVORS WITH PROPENSITY-MATCHED UNCOMPLICATED TAVI RECIPIENTS. DEVICES INCLUDED IN THE STUDY WERE COREVALVE EVOLUT R, PORTICO, COREVALVE, AND MYVAL. THE ARTICLE CONCLUDED THAT E-OHS SURVIVORS WHO OVERCOME THE INITIAL HIGH-RISK PHASE ACHIEVE 1-YEAR OUTCOMES COMPARABLE TO STANDARD TAVI PATIENTS. THESE FINDINGS SUPPORT IMMEDIATE SURGICAL BACKUP WITHIN TAVI PROGRAMS AND PROVIDE REASSURANCE FOR HIGH-RISK PATIENT COUNSELING. [THE PRIMARY AND CORRESPONDING AUTHOR WAS GIUSEPPE NASSO, DEPARTMENT OF CARDIAC SURGERY, ANTHEA HOSPITAL AND SANTA MARIA HOSPITAL GVM CARE & RESEARCH, BARI, ITALY, WITH CORRESPONDING EMAIL: [email protected]] THE TIME FRAME OF THE STUDY WAS FROM JANUARY 2020 TO AUGUST 2023. A TOTAL OF 825 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 281 (34.1%) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 77 YEARS. THE GENDER RATIO WAS NOT REPORTED FOR THE OVERALL PATIENT POPULATION. COMORBIDITIES INCLUDED CHRONIC KIDNEY DISEASE AND HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2427195 PORTICO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL UNK PORTICO

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown