BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-X LIFE TECHNOLOGIES, INC.

    MDR report key: 7660159 · Received July 3, 2018

    Report

    Report Number
    1649833-2018-00128
    Event Type
    Injury
    Date Received
    July 3, 2018
    Date of Event
    May 24, 2018
    Report Date
    September 28, 2018
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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 CRYOLIFE IS ACCURATE OR HAS BEEN CONFIRMED BY CRYOLIFE.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING RECORDS FOR THE ONXM-31/33 SN (B)(4) 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. 67.34 YEAR OLD MALE PATIENT IMPLANTED WITH ONXM-31/33 IN THE MITRAL POSITION [SN (B)(4) ] ON (B)(6)2018 AND REQUIRED EXPLANT AND REPLACEMENT VIA ADDITIONAL ONXM-31/33 ON (B)(6)2018 DUE TO "SEVERE MITRAL STENOSIS DUE TO CLOTTED MITRAL LEAFLET." PER THE OP NOTES, EXPLANTED VALVE "MITRAL VALVE WITH THROMBUS ON IT. (THERE WAS PANNUS OR VALVE TISSUE OR SUTURES)." ADDITIONAL CLARIFICATION REQUESTED INDICATED THAT THE SURGEON WAS NOT CERTAIN AT THE TIME OF EXPLANT WHAT EXACTLY WAS ON THE MITRAL VALVE DESPITE COMMENTS IN THE OP NOTES THAT STATE "I SAW NO VALVE MATERIAL AND NO SUTURES IN THE VALVE APPARATUS." REGARDLESS, THE EXPLANTED VALVE WAS SENT TO PATHOLOGY FOR ANALYSIS. AN AORTIC DISSECTION IN THE DESCENDING AORTA AND ARCH WAS REPORTED POST-OP HOWEVER THE SURGEON STATED, "I THINK THIS WAS CAUSED BY SOME COMPONENT OF THE CPB [CARDIOPULMONARY BYPASS] RUN." PATHOLOGICAL ANALYSIS STATE GROSS EXAMINATION WAS "CONSISTENT WITH THROMBUS" BUT NO CLOTS COULD BE IDENTIFIED ON THE LEAFLETS. HOWEVER, MICROSCOPIC EXAMINATION CONFIRMED THROMBUS OF "MAINLY FIBRIN COMPONENT." OBJECTIVE PERFORMANCE CRITERIA REPORT AN HISTORICAL THROMBOSIS INCIDENCE OF 0.8% PER VALVE-YEAR FOR ALL RIGID PROSTHETIC VALVES. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE INSTRUCTIONS FOR USE (IFU) ACKNOWLEDGE THROMBOEMBOLIC EVENTS AS POTENTIAL RISK FACTORS FOR MECHANICAL VALVE REPLACEMENT. THE VALVE WAS PERFORMING AS EXPECTED. THIS EVENT DOES NOT IDENTIFY ADDITIONAL HAZARDS OR MODIFY THE PROBABILITY AND SEVERITY OF EXISTING HAZARDS. 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 CRYOLIFE IS ACCURATE OR HAS BEEN CONFIRMED BY CRYOLIFE.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT AND IMPLANT REGISTRATION CARDS RECEIVED, A SIZE 31/33 MITRAL HEART VALVE WITH STANDARD SEWING RING (31/33 ONXM), SERIAL NUMBER 3773112 WAS IMPLANTED IN A 67 YEAR OLD MALE PATIENT ON (B)(6)2016. THE VALVE WAS THEN EXPLANTED AND REPLACED WITH 31/33 ONXM, SERIAL NUMBER (B)(4) ON (B)(6)2018 FOR UNDISCLOSED REASONS. NOTE: THIS INVESTIGATION IS RELEGATED TO ONXM 31/33 (SN(B)(4)). ADDITIONAL INFORMATION WAS RECEIVED VIA OPERATIVE NOTES. THE OPERATIVE NOTES INDICATE THAT THE REASON FOR EXPLANT WAS DUE TO SEVERE MITRAL STENOSIS DUE TO CLOTTED MITRAL LEAFLET.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT AND IMPLANT REGISTRATION CARDS RECEIVED, A SIZE 31/33 MITRAL HEART VALVE WITH STANDARD SEWING RING (31/33 ONXM), SERIAL NUMBER (B)(4) WAS IMPLANTED IN A 67 YEAR OLD MALE PATIENT ON 09/21/2016. THE VALVE WAS THEN EXPLANTED AND REPLACED WITH 31/33 ONXM, SERIAL NUMBER 6348911 ON 05/24/2018 FOR UNDISCLOSED REASONS. NOTE: THIS INVESTIGATION IS RELEGATED TO ONXM 31/33 (SN (B)(4)). ADDITIONAL INFORMATION WAS RECEIVED VIA OPERATIVE NOTES. THE OPERATIVE NOTES INDICATE THAT THE REASON FOR EXPLANT WAS DUE TO SEVERE MITRAL STENOSIS DUE TO CLOTTED MITRAL LEAFLET.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO CRYOLIFE IS ACCURATE OR HAS BEEN CONFIRMED BY CRYOLIFE.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL REPORT AND IMPLANT REGISTRATION CARDS RECEIVED, A SIZE 31/33 MITRAL HEART VALVE WITH STANDARD SEWING RING (31/33 ONXM), SERIAL NUMBER (B)(4) WAS IMPLANTED IN A (B)(6) MALE PATIENT ON (B)(6) 2016. THE VALVE WAS THEN EXPLANTED AND REPLACED WITH 31/33 ONXM, SERIAL NUMBER (B)(4) ON (B)(6) 2018 FOR UNDISCLOSED REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502306 ON-X LIFE TECHNOLOGIES, INC. HEART-VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXM-31/33

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| O