BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHOTOFIX UNKNOWN CONFIGURATION

    MDR report key: 24620197 · Received March 17, 2026

    Report

    Report Number
    1063481-2026-00010
    Event Type
    Death
    Date Received
    March 17, 2026
    Report Date
    May 22, 2026
    Manufacturer
    ARTIVION, INC. ¿ KENNESAW
    Product Code
    PSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.

    Description of Event or Problem · 0

    THE RECENT PUBLICATION TITLED: ¿REEVALUATING AORTIC VALVE NEOCUSPIDIZATION IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS: A CASE SERIES ANALYSIS¿. ANGELO POLITO, MD, SONIA B. ALBANESE, MD, ENRICO CETRANO, MD, MARIANNA CICENIA, MD, GABRIELE RINELLI, MD, VERONICA FELICI, MD, AND ADRIANO CAROTTI, MD WORLD JOURNAL FOR PEDIATRIC AND CONGENITAL HEART SURGERY 2026, VOL. 17(2) 213-220. DOI: 10.1177/21501351251364879 A RETROSPECTIVE COHORT STUDY (07/2016-08/2024) TO EVALUATE THE DURABILITY OF AORTIC VALVE NEOCUSPIDIZATION (AVNEO, ALSO THE OZAKI PROCEDURE) IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS. THE STUDY COHORT (N=49) INCLUDED THE USE OF VARIOUS PATCH MATERIALS FOR THEAVNEO PROCEDURE: AUTOLOGOUS (N=36), BOVINE PERICARDIUM (N=13), CARDIOCEL® (N=9) AND PHOTOFIX (N=4). ONE OF THE PHOTOFIX RECIPIENTS UNDERWENT A LATE REOPERATION 16 MONTHS POST-OP OF AVNEO REPLACEMENT FOR AORTIC WALL CUSP INCORPORATION WITH ASSOCIATED HYPERTROPHIC CARDIOMYOPATHY. THIS PATIENT UNDERWENT SUCCESSFUL HEART TRANSPLANT 4 MONTHS AFTER THE AVNEO REPLACEMENT. NOTE: LEAFLET REPAIR IS CURRENTLY LISTED AS A CONTRAINDICATION FOR THE USE OF PHOTOFIX. A REVIEW OF THE AVAILABLE LITERATURE WAS PERFORMED TO ASSESS PERFORMANCE CONSIDERATIONS FOR AORTIC VALVE NEOCUSPIDIZATION (AVNEO/OZAKI) IN PEDIATRIC AND YOUNG ADULT POPULATIONS. POLITO ET AL., IN THE PUBLICATION TITLED ¿REEVALUATING AORTIC VALVE NEOCUSPIDIZATION IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS: A CASE SERIES ANALYSIS,¿ REPORTED OUTCOMES FROM A SINGLE-CENTER RETROSPECTIVE COHORT OF 49 PATIENTS (JULY 2016 ¿ AUGUST 2024; MEDIAN FOLLOW-UP 37.8 MONTHS). WITHIN THIS COHORT, AVNEO LEAFLET RECONSTRUCTION WAS PERFORMED USING VARIOUS PERICARDIAL PATCH MATERIALS, INCLUDING: AUTOLOGOUS PERICARDIUM (PATIENT-DERIVED) AND HETEROLOGOUS/BOVINE PERICARDIUM, INCLUDING: CARDIOCEL AND PHOTOFIX AUTOLOGOUS PERICARDIUM WAS UTILIZED IN THE MAJORITY OF PATIENTS, WHILE HETEROLOGOUS MATERIALS WERE USED IN A SMALLER SUBSET, PARTICULARLY IN EARLIER CASES OR REOPERATIONS WHERE SUITABLE AUTOLOGOUS TISSUE WAS UNAVAILABLE. REPORTED ADVERSE EVENTS INCLUDE: EARLY MORTALITY. FATAL CEREBRAL HEMORRHAGE FOLLOWING KONNO + AVNEO + MECHANICAL MITRAL VALVE REPLACEMENT. CORONARY OSTIAL OBSTRUCTION / MYOCARDIAL ISCHEMIA. REDUNDANT CUSP CAUSING INTERMITTENT OBSTRUCTION OF THE LEFT CORONARY OSTIUM CONVERSION TO ROSS PROCEDURE. ASEPTIC AORTIC ROOT DISRUPTION. ASSOCIATED WITH LUNG CONGESTION HOMOGRAFT AORTIC ROOT REPLACEMENT. MEDIASTINITIS WITH AORTIC PSEUDOANEURYSM. POST-OPERATIVE INFECTION/STRUCTURAL COMPLICATION REQUIRING ROOT REPLACEMENT. STRUCTURAL VALVE DEGENERATION (SVD). LATE DEGENERATION REQUIRING REOPERATION (REPORTED IN MULTIPLE CASES). INFECTIVE ENDOCARDITIS. INCLUDING STREPTOCOCCUS ORALIS AND STAPHYLOCOCCUS EPIDERMIDIS; ONE CASE LINKED TO DENTAL PROCEDURES WITHOUT PROPHYLAXIS. AORTIC WALL CUSP INCORPORATION. STRUCTURAL INCORPORATION COMPLICATION WAS REPORTED IN ONE PATIENT. THIS INVESTIGATION IS RELEGATED TO PHOTOFIX, SERIAL NUMBER UNKNOWN, WITH AN ALLEGATION AGAINST THE PERFORMANCE AND DURABILITY OF THE HETEROLOGOUS PERICARDIAL PATCH MATERIAL UTILIZED FOR AORTIC VALVE NEOCUSPIDIZATION (AVNEO) LEAFLET RECONSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551343 PHOTOFIX UNKNOWN CONFIGURATION DECELLULARIZED BOVINE PERICARDIUM PSQ ARTIVION, INC. ¿ KENNESAW PF UNK UNKOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| O