BEUDAMED
    FDA Adverse Event Death Summary report: N

    PORTICO TRANSCATHETER AORTIC VALVE

    MDR report key: 18297725 · Received December 8, 2023

    Report

    Report Number
    2135147-2023-05411
    Event Type
    Death
    Date Received
    December 8, 2023
    Date of Event
    January 1, 2016
    Report Date
    January 8, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARIZED PATIENT OUTCOMES/COMPLICATIONS OF CHARACTERISTICS AND OUTCOMES OF PATIENTS RECEIVING A SECOND RESCUE VALVE DURING TRANSCATHETER AORTIC VALVE IMPLANTATION WERE REPORTED IN A RESEARCH ARTICLE IN A SUBJECT POPULATION WITH MULTIPLE CO-MORBIDITIES INCLUDING HYPERTENSION, DIABETES, PRIOR CARDIAC SURGERY, PRIOR MYOCARDIAL INFARCTION, PRIOR PERCUTANEOUS CORONARY INTERVENTION, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, PRIOR STROKE, CRITICAL PREOPERATIVE STATE, PERIPHERAL VASCULAR DISEASE, REDUCED MOBILITY, ATRIAL FIBRILLATION, STEROID TREATMENT, HISTORY OF MALIGNANCY, PACEMAKER IMPLANT, DEPRESSED LVEF, BICUSPID VALVE. SOME OF THE COMPLICATIONS REPORTED WERE DEATH, ACUTE CARDIAC SURGERY (SURGICAL INTERVENTION), CIRCULATORY SUPPORT (ECMO, INOTROPIC SUPPORT, UNEXPECTED MEDICAL INTERVENTION), UNPLANNED GENERAL ANESTHESIA, BLEEDING, STROKE, MYOCARDIAL INFARCTION, INFECTION NEEDING TREATMENT, RENAL REPLACEMENT THERAPY (RENAL FAILURE), NEW PACEMAKER IMPLANT, MALPOSITION, AND DEVICE EMBOLIZATION 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. LITERATURE ATTACHMENT: ARTICLE TITLED "CHARACTERISTICS AND OUTCOMES OF PATIENTS RECEIVING A SECOND RESCUE VALVE DURING TRANSCATHETER AORTIC VALVE IMPLANTATION".

    Additional Manufacturer Narrative · 0

    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, "CHARACTERISTICS AND OUTCOMES OF PATIENTS RECEIVING A SECOND RESCUE VALVE DURING TRANSCATHETER AORTIC VALVE IMPLANTATION", WAS REVIEWED. THE ARTICLE PRESENTED A RETROSPECTIVE, MULTICENTER STUDY TO STUDY THE OCCURRENCE AND OUTCOMES OF ADDITIONAL RESCUE VALVE (RESCUE-AV) IN A NATIONWIDE REGISTRY. DEVICES INCLUDED IN THIS STUDY WERE ABBOTT NAVITOR, ABBOTT PORTICO, BOSTON ACURATE NEO, BOSTON ACURATE NEO2, BOSTON ACURATE TA, BOSTON LOTUS, BOSTON LOTUS EDGE, EDWARDS SAPIEN 3, EDWARDS SAPIEN 3 ULTRA, EDWARDS SAPIEN AND SAPIEN XT, MEDTRONIC COREVALVE, MEDTRONIC EVOLUT PRO, MEDTRONIC EVOLUT PRO PLUS, MEDTRONIC EVOLUT R, AND MERIL MYVAL. THE ARTICLE CONCLUDED AMONG TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PATIENTS IN A NATIONWIDE REGISTER, RESCUE-AV OCCURRED IN 1.3% OF PATIENTS. THE 30-DAY MORTALITY IN PATIENTS RECEIVING RESCUE-AV WAS HIGH, BUT LONG-TERM OUTCOME AMONG 30-DAY SURVIVORS WAS SIMILAR TO THE CONTROL GROUP [THE PRIMARY AND CORRESPONDING AUTHOR WAS HENRIK BJURSTEN, LUND UNIVERSITY, SKÅNE UNIVERSITY HOSPITAL, LUND, SWEDEN, WITH CORRESPONDING EMAIL: [email protected]]. THE TIME FRAME OF THE STUDY WAS FROM JANUARY 2016 TO DECEMBER 2021. A TOTAL OF 5948 PATIENTS WERE INCLUDED IN THIS STUDY, OF WHICH 256 (4.3%) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 81.1 YEARS AND THE AVERAGE GENDER WAS MALE. COMORBIDITIES INCLUDED HYPERTENSION, DIABETES, PRIOR CARDIAC SURGERY, PRIOR MYOCARDIAL INFARCTION, PRIOR PERCUTANEOUS CORONARY INTERVENTION, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, PRIOR STROKE, CRITICAL PREOPERATIVE STATE, PERIPHERAL VASCULAR DISEASE, REDUCED MOBILITY, ATRIAL FIBRILLATION, STEROID TREATMENT, HISTORY OF MALIGNANCY, PACEMAKER IMPLANT, DEPRESSED LVEF, BICUSPID VALVE. PERI- AND POST-PROCEDURAL COMPLICATIONS INCLUDED DEATH, ACUTE CARDIAC SURGERY (SURGICAL INTERVENTION), CIRCULATORY SUPPORT (ECMO, INOTROPIC SUPPORT, UNEXPECTED MEDICAL INTERVENTION), UNPLANNED GENERAL ANESTHESIA, BLEEDING, STROKE, MYOCARDIAL INFARCTION, INFECTION NEEDING TREATMENT, RENAL REPLACEMENT THERAPY (RENAL FAILURE), NEW PACEMAKER IMPLANT, MALPOSITION, AND DEVICE EMBOLIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1824274 PORTICO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| D| S| L