BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOTOFIX UNKNOWN CONFIGURATION

    MDR report key: 23533652 · Received November 12, 2025

    Report

    Report Number
    1063481-2025-00110
    Event Type
    Injury
    Date Received
    November 12, 2025
    Report Date
    January 6, 2026
    Manufacturer
    ARTIVION, INC.
    Product Code
    PSQ
    PMA / PMN Number
    K183635
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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.

    Additional Manufacturer Narrative · 0

    ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNMET. NO ADDITIONAL INFORMATION RELATED TO THE OPERATIVE NOTES FOR THE INCIDENT AND REINTERVENTION WERE NOT PROVIDED. NOR WERE ANY ADDITIONAL INFORMATION RELATED TO THE PATIENT MEDICAL HISTORY OR COMORBIDITIES PROVIDED. NO DIAGNOSTIC IMAGES HAVE BEEN PROVIDED RELATED TO THE REPORTED OBSTRUCTION; AND THE PATCH REMAINS IMPLANTED, SO NO TISSUE SAMPLES WERE RETURNED FOR FURTHER EVALUATION. PER INFORMATION PROVIDED, THE OBSTRUCTION WAS TREATED NON-SURGICALLY BY A STENT DILATATION. POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF PERICARDIUM INCLUDE ADHESION, EPICARDIAL INFLAMMATORY REACTIONS, AND REJECTION AND ARE INCLUDED IN THE INSTRUCTIONS FOR USE. THE CAUSE OF THE DESCRIBED EVENTS IS UNKNOWN. THE PHOTOFIX MANUFACTURING PROCESS INCLUDES 100% VISUAL INSPECTION PRIOR TO FINAL PACKAGING. THERE IS INSUFFICIENT INFORMATION AVAILABLE TO DETERMINE THE PRECISE CAUSE AND EFFECT RELATIONSHIP BETWEEN THE PHOTOFIX PRODUCT AND THE REPORTED ADVERSE EVENT. THE RISK FILE WAS REVIEWED, AND IT THOROUGHLY IDENTIFIES THE PROCESS AND PRODUCT HAZARDS FOR APPROVED INDICATIONS. EACH INDIVIDUAL HAZARD IS MITIGATED AND REDUCED AS FAR AS POSSIBLE BY DESIGN AND PROCESS. POST-PRODUCTION RESIDUAL RISK IS COMMUNICATED IN THE PRODUCT¿S LABELING AND IFU (INSTRUCTIONS FOR USE). THERE IS INSUFFICIENT INFORMATION AVAILABLE TO DETERMINE THE PRECISE CAUSE AND EFFECT RELATIONSHIP BETWEEN THE PHOTOFIX PRODUCT AND THE REPORTED ADVERSE EVENT. POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF PERICARDIUM INCLUDE ADHESION, EPICARDIAL INFLAMMATORY REACTIONS, AND REJECTION AND ARE INCLUDED IN THE INSTRUCTIONS FOR USE. THIS EVENT DOES NOT IDENTIFY ADDITIONAL HAZARDS OR MODIFY THE PROBABILITY AND SEVERITY OF EXISTING HAZARDS. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT ARTIVION- FORMERLY CRYOLIFE/JOTEC AND THE IFU ADEQUATELY COMMUNICATES RISK. FIELD ASSURANCE WILL CONTINUE TO MONITOR SIMILAR COMPLAINTS TO DETERMINE IF ADDITIONAL ACTIONS ARE WARRANTED; HOWEVER, AT THIS TIME NO FURTHER ACTIONS ARE NECESSARY. 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: ¿SCIMITAR SYNDROME: UPDATED FOLLOW-UP OF THE MULTIPATCH TECHNIQUE¿. ROBERT L. GEGGEL AND CHRISTOPHER W. BAIRD. JTCVS TECHNIQUES 2025;32:111-4. HTTPS://DOI.ORG/10.1016/J.XJTC.2025.05.023. IT REPORTS ON A SERIES OF PATIENTS UNDERGOING SURGICAL REPAIR OF SCIMITAR SYNDROME WITH THE USE OF PATCH MATERIAL. PHOTOFIX WAS USED IN ONE OF THE PATIENTS AND THIS PATIENT SUBSEQUENTLY DEVELOPED POST-OPERATIVE SCIMITAR VEIN OBSTRUCTION. THE OBSTRUCTION INVOLVED THE LENGTH OF THE BAFFLE AND NOT THE SCIMITAR VEIN-ATRIAL JUNCTION AND WAS TREATED NON-SURGICALLY BY STENT DILATION OF BAFFLE PATHWAY. THIS INVESTIGATION IS RELEGATED TO PHOTOFIX, SIZE UNKNOWN AND LOT NUMBER UNKNOWN WITH ALLEGATION OF OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2228532 PHOTOFIX UNKNOWN CONFIGURATION PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM PSQ ARTIVION, INC. PF UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention