BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT

    MDR report key: 16351226 · Received February 10, 2023

    Report

    Report Number
    1649833-2023-00005
    Event Type
    Injury
    Date Received
    February 10, 2023
    Date of Event
    December 5, 2022
    Report Date
    April 13, 2023
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    UDI-DI
    00851788001525
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING RECORDS WERE REVIEWED AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. ALL LOTS PASSED FUNCTIONAL TESTING AND MET RELEASE SPECIFICATIONS. DURING THE INVESTIGATION NO NON-CONFORMANCES OR DEVIATIONS WERE FOUND TO BE RELATED TO THE COMPLAINT. ON (B)(6) 2022, THE PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT WITH AN ONXAAP-23 SN (B)(6). THE PROVIDED MEDICAL RECORDS, AFTER TRANSLATION, GIVE A POST-OPERATIVE DIAGNOSIS AT THE TIME OF INITIAL DISCHARGE OF ¿ENDOCARDITIS AORTIC ABOUT BENTALL MECHANICAL, COMPLICATED WITH ABSCESS¿, BUT NO MICROBIOLOGY RESULTS OR INDICATION OF SOURCE OF INFECTION WAS INCLUDED. THEN ACCORDING TO THE ADVERSE EVENT CASE REPORT FORM THEY WERE DIAGNOSED WITH ENDOCARDITIS ON (B)(6) 2022 (68 DAYS POST-IMPLANT), AND ON (B)(6) 2022 (72 DAYS POST IMPLANT) UNDERWENT AN EXPLANT SURGERY OF THE ONXAAP DEVICE. THE EXPLANTED VALVE WAS NOT RETURNED FOR EXAMINATION, AND THE PROVIDED MEDICAL RECORDS WITH LIMITED TRANSLATION WERE THE ONLY RECORDS AVAILABLE FOR REVIEW. WITH THE INFORMATION PROVIDED, THE SOURCE OF THE ENDOCARDITIS IS UNKNOWN. HOWEVER, BECAUSE ALL ON X VALVES UNDERGO VALIDATED TERMINAL STERILIZATION PRIOR TO DISTRIBUTION, THE VALVE IS UNLIKELY TO BE THE SOURCE OF THE INFECTION. THE INSTRUCTIONS FOR USE (IFU) FOR THE ON-X VALVE STATES THAT REOPERATION, INCLUDING EXPLANTATION, MAY RESULT FROM A COMPLICATION, IN THIS CASE, ENDOCARDITIS, A KNOWN POTENTIAL EVENT ACKNOWLEDGED IN THE IFU. THOUGH RARE, HISTORICALLY, ENDOCARDITIS OCCURS AT A RATE OF 0.3 %/PATIENT-YEAR FOR MECHANICAL AORTIC HEART VALVES [ISO 5840-2:2021]. ENDOCARDITIS IS THE ROOT CAUSE FOR THE EXPLANTATION OF THE AORTIC VALVE. BECAUSE ALL ON-X VALVES UNDERGO VALIDATED TERMINAL STERILIZATION PRIOR TO DISTRIBUTION, THE VALVE IS UNLIKELY TO BE THE SOURCE OF THE INFECTION. 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). NO NEW RISKS WERE IDENTIFIED DURING THE COURSE OF THE REVIEW. 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- FORMERLY CRYOLIFE/JOTEC IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.

    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

    ACCORDING TO THE INITIAL REPORT RECEIVED, PATIENT IN THIS STUDY EXPERIENCED ENDOCARDITIS WITH INFECTION ON (B)(6) 2022. SUBSEQUENTLY, THIS ON-X VALVE WAS EXPLANTED ON (B)(6) 2022.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT RECEIVED, PATIENT IN THIS STUDY EXPERIENCED ENDOCARDITIS WITH INFECTION ON (B)(6) 2022. SUBSEQUENTLY, THIS ON-X VALVE WAS EXPLANTED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161484 ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT HEART-VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXAAP-23 00851788001525

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Unknown Hospitalization| R