BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTICO TRANSCATHETER AORTIC VALVE

    MDR report key: 24915918 · Received April 17, 2026

    Report

    Report Number
    2135147-2026-02537
    Event Type
    Injury
    Date Received
    April 17, 2026
    Date of Event
    September 1, 2022
    Report Date
    April 17, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 HYPERTENSION, DIABETES, DYSLIPIDEMIA, CORONARY ARTERY DISEASE, HEART BLOCK, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, AND PRIOR MYOCARDIAL INFARCTION, ATRIAL FIBRILLATION, TRANSIENT ISCHEMIC ATTACK, AND CEREBROVASCULAR ACCIDENT. COMPLICATIONS REPORTED INCLUDED STROKE, CARDIAC ARREST, PERICARDIAL EFFUSION, HEART BLOCK, ARRHYTHMIA, SURGICAL INTERVENTION (PERMANENT PACEMAKER), UNEXPECTED MEDICAL INTERVENTION (PERICARDIOCENTESIS); 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. LITERATURE: RAPID ATRIAL PACING-INDUCED WENCKEBACH ATRIOVENTRICULAR BLOCK: A POOR PREDICTOR OF PERMANENT PACEMAKER NEED POST-TAVR. B3: EVENT DATE WAS ESTIMATED. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

    Description of Event or Problem · 0

    THE ARTICLE, "RAPID ATRIAL PACING-INDUCED WENCKEBACH ATRIOVENTRICULAR BLOCK: A POOR PREDICTOR OF PERMANENT PACEMAKER NEED POST-TAVR", WAS REVIEWED. THIS RESEARCH ARTICLE IS A PROSPECTIVE MULTICENTER EXPERIENCE TO EVALUATE THE PREDICTIVE VALUE OF RAPID ATRIAL PACING (RAP)-INDUCED WENCKEBACH ATRIOVENTRICULAR BLOCK (W-AVB) FOR PERMANENT PACEMAKER IMPLANT (PPI) AND SUDDEN CARDIAC DEATH WITHIN 30 DAYS POST-TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THE DEVICES INCLUDED IN THIS STUDY WERE PORTICO/NAVITOR, EVOLUT/PRO/PRO+, ACURATE NEO/NEO2, AND SAPIEN XT/S3/S3 ULTRA. THE ARTICLE CONCLUDED THAT RAP-INDUCED W-AVB DEMONSTRATED LIMITED UTILITY IN PREDICTING POST-TACR PPO OR SUDDEN CARDIAC DEATH, PARTICULARLY IN PATIENTS AT HIGH-RISK FOR PPI. [THE PRIMARY AND CORRESPONDING AUTHOR WAS IAN BUYSSCHAERT, DEPARTMENT OF CARDIOLOGY, AZ SINT JAN BRUGGE AV, RUDDERSHOVE 10, B-8000 BRUGGE, BELGIUM, WITH CORRESPONDING E-MAIL: [email protected].] THIS STUDY INCLUDED PATIENTS UNDERGOING TAVR FROM 01 SEPTEMBER 2022 TO 31 MAY 2024. A TOTAL OF 640 PATIENTS WERE INCLUDED IN THE STUDY, OF WHICH 14.6% (80) RECEIVED AN ABBOTT DEVICE. THE AVERAGE AGE WAS 82.1 YEARS. THE MAJORITY GENDER WAS MALE. COMORBIDITIES INCLUDED HYPERTENSION, DIABETES, DYSLIPIDEMIA, CORONARY ARTERY DISEASE, HEART BLOCK, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, AND PRIOR MYOCARDIAL INFARCTION, ATRIAL FIBRILLATION, TRANSIENT ISCHEMIC ATTACK, AND CEREBROVASCULAR ACCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69044 PORTICO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL UNK PORTICO

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| S