BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXICOR

    MDR report key: 23408498 · Received October 28, 2025

    Report

    Report Number
    3005619880-2025-00012
    Event Type
    Injury
    Date Received
    October 28, 2025
    Report Date
    October 28, 2025
    Manufacturer
    ELUTIA INC
    Product Code
    DXZ
    PMA / PMN Number
    K063349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLE IS AVAILABLE FOR EVALUATION. LHR REVIEW IS UNABLE TO BE COMPLETED AS THE PRODUCT INFORMATION (MODEL NUMBER AND LOT NUMBER) IS UNKNOWN. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME, SHOULD ELUTIA RECEIVE ANY ADDITIONAL DETAILS RELATED TO THIS EVENT, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    AS PART OF THE POST MARKET SURVEILLANCE PROCESS, PUBLICATION OF THE ARTICLE ENTITLED "IMPACT OF KONNO PROCEDURE ON RIGHT HEART FUNCTION" BY PAULAMY GANGULY, BS ET AL WAS REVIEWED AND SUMMARIZED AS FOLLOWS: A 62-YEAR OLD WOMAN WITH PRIOR MECHANICAL AORTIC AND MITRAL VALVE REPLACEMENTS UNDERWENT A KONNO PROCEDURE. IN (B)(6) 2021, SHE PRESENTED WITH LEFT VENTRICULAR HYPERTROPHY AND PATIENT-PROSTHESIS MISMATCH (PPM) ALONG WITH STENOSIS OF THE MECHANICAL AORTIC VALVE. SHE UNDERWENT A MODIFIED KONNO PROCEDURE USING A COMATRIX PATCH AND A SUBSEQUENT REDO WITH A 23MM MECHANICAL AORTIC VALVE REPLACEMENT. THIS SURGERY WAS ALSO COMPLICATED BY STERNAL WOUND INFECTION, ACUTE KIDNEY INJURY, AND PROLONGED MECHANICAL VENTILATION. IN (B)(6) 2022, THE PATIENT UNDERWENT A TRANSCATHETER PULMONARY VALVE REPLACEMENT (TPVR) USING AN ALTERRA/SAPIEN 3 VALVE WITHOUT COMPLICATIONS. THREE MONTHS AFTER THE TPVR, HER SYMPTOMS IMPROVED FROM NYHA FUNCTIONAL CLASS IV TO FUNCTIONAL CLASS II SYMPTOMS, AND SHE NO LONGER REQUIRED PARACENTESES WITH OPTIMIZED MEDICAL THERAPY. THE ARTICLE CONCLUDED THAT THE KONNO PROCEDURE MAY BE USED TO ENLARGE THE LVOT AND THE AORTIC VALVE ANNULUS; HOWEVER, THE TECHNIQUE IS COMPLEX IN THAT AN ANTERIOR APPROACH WITH EXPOSURE THROUGH A RIGHT VENTRICULOTOMY INCISION IS USED TO OPEN THE AORTIC ROOT VIA A VERTICAL AORTOTOMY DOWN TO THE IVS. THE LVOT IS THEN ENLARGED WITH A PATCH RECONSTRUCTION, AND A SECOND PATCH IS USED TO CLOSE THE RIGHT VENTRICULAR INCISION. AS SEEN IN THIS CASE, ALTHOUGH THE KONNO PROCEDURE IS A LEFT-SIDED SURGICAL INTERVENTION, IT MAY LEAD TO RIGHT-SIDED HEART FAILURE POSTOPERATIVELY DUE TO PULMONARY OR TRICUSPID VALVE DYSFUNCTION. THE AUTHOR HYPOTHESIZED THAT THE ETIOLOGY OF RIGHT-SIDED HEART FAILURE SEEN IN THIS CASE MAY BE ATTRIBUTED TO POSTOPERATIVE DISRUPTION OF THE PULMONARY VALVE ANNULUS AND RIGHT VENTRICULAR OUTFLOW TRACT (BASED ON PROXIMITY OF THE PATCH TO THE PULMONARY ANNULUS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1679096 PROXICOR PATCH, PLEDGET-INTRACARDIAC-DXZ, PRODUCT CODE: DXZ DXZ ELUTIA INC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention