BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17835294 · Received September 28, 2023

    Report

    Report Number
    1649833-2023-00035
    Event Type
    Injury
    Date Received
    September 28, 2023
    Date of Event
    August 30, 2023
    Report Date
    December 4, 2023
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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- FORMERLY CRYOLIFE/JOTEC IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.

    Additional Manufacturer Narrative · 0

    NO SAMPLE EVALUATION WAS PERFORMED AS THE DEVICE REMAINS IMPLANTED. 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 NOTED. ON (B)(6) 2022 AN ONXAAP-23 WAS IMPLANTED IN A 52-YEAR-OLD MALE AND ON (B)(6) 2023 (323 DAYS POST IMPLANT) HE WAS HOSPITALIZED WITH A DIAGNOSIS OF RIGHT SIDED CEREBELLAR STROKE. LIMITED INFORMATION WAS PROVIDED REGARDING THE EVENT AND NO MEDICAL RECORDS WERE PROVIDED. ACCORDING TO COMMUNICATIONS, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2023 (1 DAY POST INCIDENT) AND IS DOING WELL. TREATMENT IN RESPONSE TO THE STROKE WAS TO MAINTAIN INR AT 2.0-3.0. IT IS UNKNOWN IF THERE WERE ANY CONTRIBUTING FACTORS AND THE INR AT THE TIME OF THE INCIDENT IS ALSO UNKNOWN. THE DEVICE HISTORY RECORD CONCLUDED THAT THE AAP DEVICE PASSED ON-X ACCEPTANCE CRITERIA PRIOR TO INITIAL RELEASE. THROMBOEMBOLISM IS RECOGNIZED AS A POTENTIAL ADVERSE EVENT IN THE INSTRUCTIONS FOR USE [IFU] AND OCCURS AT A HISTORICAL RATE OF 1.6%/VALVE-YEAR FOR MECHANICAL AORTIC VALVES [ISO 5840]. WITH THE AVAILABLE INFORMATION, IT IS UNKNOWN WHAT, IF ANY, CONTRIBUTION THE VALVE HAD TO THE OCCURRENCE OF THIS STROKE OR IF THE PATIENT'S PAST MEDICAL HISTORY OR INR LEVEL WERE CONTRIBUTORY FACTORS. 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.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT RECEIVED "PATIENT IMPLANTED WITH ONXAAP-23 ON (B)(6) 2022. PATIENT ADMITTED TO HOSPITAL ON (B)(6) 2023 WITH RIGHT SIDED CEREBELLAR STROKE. PATIENT RELEASED NEXT DAY (B)(6) 2023 DOING WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2246302 ON-X ASCENDING AORTIC PROSTHESIS WITH THE VASCUTEK GELWEAVE VALSALVA GRAFT HEART-VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXAAP-23

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Other