BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-X PROSTHETIC AORTIC VALVE WITH ANATOMIC SEWING RING WITH EXTENDED HOLDER

    MDR report key: 8556395 · Received April 26, 2019

    Report

    Report Number
    1649833-2019-00026
    Event Type
    Malfunction
    Date Received
    April 26, 2019
    Date of Event
    April 18, 2019
    Report Date
    September 20, 2019
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO INITIAL REPORTS, THE SEWING RING DISCONNECTED FROM THE HOUSING PRIOR TO IMPLANT. SUTURES WERE IN PLACE AND THE VALVE WAS BEING MOVED DOWN INTO POSITION WHEN THE VALVE HOUSING SEPARATED. THE VALVE WAS RETURNED FOR OBSERVATION. AN EVALUATION OF THE RETURNED ONXANE-21 SN (B)(6) WAS PERFORMED. THE VALVE WAS RECEIVED WITH THE SEWING CUFF ASSEMBLY SEPARATE FROM THE CARBON SUB-ASSEMBLY. A VISUAL EXAMINATION OF THE SEWING CUFF FOUND NO EVIDENCE OF FRAYS, TEARS, UNRAVELING OF THE CUFF, OR ANY OTHER DAMAGE. THE SEWING CUFF WAS X-RAYED TO ASSESS THE BUILD OF THE SEWING CUFF CONFIGURATION. THE X-RAY IMAGES REVEAL 2 RINGS ARE IN PLACE IN THE LOCATIONS EXPECTED FOR A CORRECTLY FABRICATED SEWING CUFF. THE FABRIC CONFIGURATION, STITCHING, ORIENTATION MARKS, AND RING PLACEMENT WERE ASSESSED WITH AN EXPERIENCED CUFF FABRICATOR WITHIN ON-X. THE ASSESSMENT FINDS THE FABRICATION APPEARS TO BE NORMAL AND WAS CORRECTLY ORIENTED AT ASSEMBLY AS EVIDENCED BY THE LOCATION OF THE ORIENTATION MARKS ON THE SEWING CUFF. THE SEWING CUFF WAS DISASSEMBLED AND THE SEWING RINGS WERE MEASURED FOLLOWING THE SEWING RING DIMENSIONAL INSPECTION PROCEDURE TO VERIFY THE SIZE AND TYPE OF RINGS USED IN THIS BUILD. THE RINGS WERE NOT SPLIT OR BROKEN. RINGS PASSED THE DIMENSIONAL SPECIFICATIONS. ON ONE OF THE RINGS IT WAS NOTED IT WAS NOT SITTING FLAT ON THE INSPECTION SURFACE AND SLIGHTLY OUT OF ROUND. THE HOUSING AND LEAFLETS PASSED VISUAL AND CMM DIMENSIONAL INSPECTION. HOUSING OD AND PROFILE PASSES THE COMPARATOR OVERLAY INSPECTION INDICATING THE HOUSING OD AND RETAINING FEATURE WERE THE CORRECT SIZE AND SHAPE FOR THE VALVE CONFIGURATION. NO DAMAGE WAS FOUND ON EITHER THE HOUSING OR THE LEAFLETS. REVIEW OF THE FINAL ASSEMBLY PROCESSING RECORDS DOES NOT INDICATE ANY UNUSUAL EVENTS OR ANOMALIES OCCURRING WITHIN THE FABRICATION OF THE VALVE. THE SEWING CUFF TORQUE INSPECTION VALUE RECORDED IS IN THE MIDDLE OF THE TORQUE SPECIFICATION RANGE AND IS A TYPICAL VALUE FOR THIS CONFIGURATION, WHICH INDICATES THE SEWING CUFF WAS CORRECTLY FABRICATED AND FUNCTIONALLY ACCEPTABLE IN THE FINAL VALVE ASSEMBLY CONFIGURATION. MULTIPLE SCENARIOS WERE DISCUSSED AND AN ATTEMPT TO DUPLICATE THE EVENT WAS PERFORMED. HOWEVER, THE CONCLUSION OF THE EVALUATION IS THAT NO EVIDENCE WAS DISCOVERED TO SUGGEST THE ONXANE-21 VALVE (SER# (B)(6)) HAD BEEN FABRICATED INCORRECTLY. THE REPORTED EVENT OF THE SEWING CUFF SEPARATING FROM THE SUBASSEMBLY DURING IMPLANTATION CANNOT BE EXPLAINED AND DOES NOT APPEAR TO BE DUE TO THE MANUFACTURE OR DESIGN OF THE VALVE. BASED ON THE SAMPLE EVALUATION OF THE VALVE DEFINITIVE ROOT CAUSE OF THE CARBON SUB-ASSEMBLY SEPARATING FROM THE SEWING CUFF CANNOT BE DETERMINED. THE PRODUCT WILL BE SCRAPPED. THE MANUFACTURING RECORDS FOR THE ONXANE-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. DURING THE INVESTIGATION NO NON-CONFORMANCES OR DEVIATIONS WERE NOTED. 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 · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ACCORDING TO INITIAL REPORTS, ONCE VALVE SUTURES WERE IN PLACE AND THE VALVE WAS BEING SEATED, THE SEWING CUFF DETACHED FROM THE VALVE HOUSING. SURGERY WAS PROLONGED AND THERE WAS NO ADVERSE EVENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347017 ON-X PROSTHETIC AORTIC VALVE WITH ANATOMIC SEWING RING WITH EXTENDED HOLDER HEART-VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXANE-21

    Patients

    Seq Age Sex Outcome Treatment
    1 Other