BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONX AORTIC CONFORM EXT 21

    MDR report key: 21000668 · Received December 23, 2024

    Report

    Report Number
    1649833-2024-00073
    Event Type
    Injury
    Date Received
    December 23, 2024
    Date of Event
    October 18, 2024
    Report Date
    January 6, 2025
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MEDWATCH REPORT (MDR REPORT # MW5162053) FILED BY THE USER FACILITY. 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 ¿ FORMERLY CRYOLIFE/JOTEC.

    Additional Manufacturer Narrative · 0

    THE USER FACILITY SUBMITTED A REPORT TO THE FDA REGARDING THIS EVENT. THE MDR REPORT # FOR THAT SUBMISSION IS MW5162053. ACCORDING TO INITIAL REPORTS FROM GREG FEATHERSTONE, CARDIOVASCULAR SPECIALIST, ARTIVION, INC., PHYSICIAN IMPLANTED A SIZE 21 ONXACE AND SUTURES IT IN PLACE USING THE CORKNOT DEVICE. WHEN THEY CUT THE RELEASE SUTURE THE HOLDER WOULD NOT COLLAPSE. THEY ROTATED THE VALVE AND TRIED TO GET THE HOLDER FREE BUT ULTIMATELY HAD TO REMOVE THE IMPLANT. SURGERY WAS PROLONGED. ADDITIONAL INFORMATION RECEIVED. "VALVE HANDLE DID NOT RELEASE FROM VALVE. TISSUE INJURY RESULTED IN THE NEED FOR ADDITIONAL PROCEDURES." "THE PATIENT RECOVERED FROM THE INCIDENCE. THE STITCHES WERE RECORDED AS TEARING FROM THE AORTA." MULTIPLE ATTEMPTS TO RECEIVE THE DEVICE BACK HAVE GONE UNMET. THE DEVICE WILL NOT BE RETURNED. THIS INVESTIGATION IS RELEGATED TO ONXACE-21, SN (B)(6) FOR SUTURE/HOLDER RELEASE ISSUES. THE MANUFACTURING RECORDS FOR THE ONXACE-21, SN (B)(6) 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. A REVIEW OF THE AVAILABLE INFORMATION WAS PERFORMED. ONXACE-21 SN (B)(6) WAS IMPLANTED IN A PATIENT OF UNKNOWN GENDER AND AGE, IN THE AORTIC POSITION, ON AN UNSPECIFIED DATE. THE VALVE WAS EXPLANTED ON THE SAME DAY, WITH THE ALLEGATION THAT THE VALVE HOLDER WOULD NOT RELEASE FROM THE VALVE. FURTHER INFORMATION PROVIDED BY THE SURGEON INDICATED THAT THE "VALVE HANDLE DID NOT RELEASE FROM THE VALVE," LEADING TO TISSUE INJURY THAT NECESSITATED ADDITIONAL PROCEDURES. THE SURGICAL NOTES RECORDED THAT THE STITCHES TORE FROM THE AORTA. THE PATIENT REPORTEDLY RECOVERED FROM THE INCIDENT. A REVIEW OF THE PROCESSING RECORDS REVEALED NO ISSUES DURING MANUFACTURING OR PROCESSING, AND THE VALVE PASSED ALL INSPECTIONS, MEETING THE REQUIRED SPECIFICATIONS BEFORE SHIPMENT. HOWEVER, THE VALVE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION, AND NO MEDICAL RECORDS WERE PROVIDED. AS A RESULT, THERE IS INSUFFICIENT INFORMATION TO DETERMINE A PROBABLE CAUSE FOR THE VALVE HOLDER NOT RELEASING PROPERLY, WHETHER IT WAS DUE TO A MECHANICAL MALFUNCTION OR THE IMPLANTING TECHNIQUE. CONSEQUENTLY, THERE IS INSUFFICIENT DATA TO ESTABLISH A CLEAR RELATIONSHIP BETWEEN THE VALVE AND THE DECISION TO EXPLANT. THE INSTRUCTIONS FOR USE (IFU) FOR THE ON-X VALVE ACKNOWLEDGE THAT REOPERATION AND EXPLANTATION MAY BE REQUIRED AS POTENTIAL CONSEQUENCES FOLLOWING COMPLICATIONS DURING PROSTHETIC VALVE REPLACEMENT. DUE TO THE LIMITED INFORMATION PROVIDED AND THE VALVE NOT BEING RETURNED FOR INSPECTION, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE VALVE HOLDER'S FAILURE TO RELEASE PROPERLY. THE LACK OF DIRECT EXAMINATION OF THE VALVE AND THE ABSENCE OF COMPREHENSIVE MEDICAL RECORDS PREVENTS A CONCLUSIVE ANALYSIS. THE REPORTED EVENTS WILL CONTINUE TO BE MONITORED FOR TRENDS. NO UPDATES TO THE RMF ARE NEEDED IN RESPONSE TO THIS COMPLAINT. RISK HAS BEEN REDUCED AS LOW AS POSSIBLE AND OVERALL RESIDUAL RISK IS ACCEPTABLE. 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 ¿ FORMERLY CRYOLIFE/JOTEC.

    Description of Event or Problem · 0

    ACCORDING TO INITIAL REPORTS, PHYSICIAN IMPLANTED A SIZE 21 ONXACE AND SUTURED IT IN PLACE USING THE CORKNOT DEVICE. WHEN THEY CUT THE RELEASE SUTURE THE HOLDER WOULD NOT COLLAPSE. THEY ROTATED THE VALVE AND TRIED TO GET THE HOLDER FREE BUT ULTIMATELY HAD TO REMOVE THE IMPLANT. SURGERY WAS PROLONGED. THIS INVESTIGATION IS RELEGATED TO ONXACE-21, SN (B)(6) FOR SUTURE ISSUES. ADDITIONAL INFORMATION RECEIVED VIA A MEDWATCH REPORT (MDR REPORT # MW5162053) FILED BY THE USER FACILITY. ACCORDING TO THE SUBMISSION "VALVE HANDLE DID NOT RELEASE FROM VALVE. TISSUE INJURY RESULTED IN THE NEED FOR ADDITIONAL PROCEDURES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2624611 ONX AORTIC CONFORM EXT 21 HEART-VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXACE-21

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male Required Intervention