BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONX AORTIC ANATOMIC EXT 27/29

    MDR report key: 6402299 · Received March 14, 2017

    Report

    Report Number
    1649833-2017-00025
    Event Type
    Injury
    Date Received
    March 14, 2017
    Date of Event
    January 26, 2017
    Report Date
    April 27, 2017
    Manufacturer
    ONX LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CORRECTION TO PMA/510(K) NUMBER - P000037.  THE MANUFACTURING RECORDS FOR THE ONXANE-27/29 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. DURING THE INVESTIGATION NO NON-CONFORMANCES OR DEVIATIONS WERE NOTED. A REVIEW OF THE AVAILABLE INFORMATION WAS PERFORMED. THE ONXANE-27/29 SN (B(4) IMPLANTED (B)(6) 2017 IN (B)(6) YEAR OLD MALE IN THE AORTIC POSITION. TEN DAYS LATER ((B)(6) 2017) THIS VALVE WAS REPLACED WITH ONXANE-25 SN (B)(4) DUE TO MODERATE PARAVALVULAR LEAK (PVL) AND EPISODES OF HIGH-GRADE FEVER OF PATIENT. OPERATIVE NOTES WERE AVAILABLE FOR BOTH SURGERIES. TRANSESOPHAGEAL ECHO {TEE) DID NOT REVEAL ANY EVIDENCE OF VEGETATION (WHICH WOULD IMPLICATE INFECTION AND TISSUE DEGENERATION). FIRST VALVE WAS IMPLANTED USING RUNNING SUTURES. PVL WAS ATTRIBUTED TO SUTURES TORN AWAY FROM A PORTION OF THE ANNULUS TISSUE LEAVING A GAP BETWEEN THE CUFF AND THE ANNULUS. THE REPLACEMENT SURGERY USED PLEDGETS TO HELP ANCHOR THE SUTURES TO THE ANNULUS AND RELIEVE SOME OF THE STRAIN AT THE SUTURE-TISSUE INTERFACE. PVL IS A KNOWN POTENTIAL COMPLICATION OF PROSTHETIC HEART VALVE REPLACEMENT AND LISTED AS SUCH IN THE INSTRUCTIONS FOR USE (IFU). AS THIS REOPERATION OCCURRED ONLY TEN DAYS AFTER THE FIRST AND NO VEGETATION WAS FOUND, THE SEPARATION OF SUTURES FROM TISSUE IS PRIMARILY ATTRIBUTED TO THE SURGICAL TECHNIQUE EMPLOYED, IN PARTICULAR, THE INITIAL DECISION TO USE A NON-PLEDGETED, CONTINUOUS SUTURING TECHNIQUE. ROOT CAUSE FOR THIS EVENT IS SURGICAL TECHNIQUE OF CONTINUOUS, NON-PLEDGETED SUTURES INCOMPATIBLE WITH VIABILITY OF ANNULAR TISSUE. THE CAUSE OF THE FEVER IS UNKNOWN; HOWEVER, THE ON-X VALVE UNDERGOES A VALIDATED TERMINAL STERILIZATION PROCESS AND THEREFORE LIKELY NOT RELATED TO THE CLINICALLY NOTED FEVER. NO FURTHER ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    ACCORDING TO OPERATIVE NOTES, "RIGHT AND LEFT VENTRICULAR FUNCTIONS WERE NORMAL. NEWLY IMPLANTED PROSTHESIS APPEARED TO BE OPENING WELL. THERE WAS, HOWEVER, MODERATE PARAVALVULAR LEAK ORIGINATING FROM A SMALL OPENING NEAR THE RIGHT AND NONCORONARY COMMISSURES. THERE WAS ALSO SUGGESTION OF A SMALL RESIDUAL LEAKS IN AT LEAST ONE OTHER SPOT ALONG THE LEFT CORONARY ANNULUS. WE THEN PROCEEDED TO EXPOSE THE AORTIC VALVE THROUGH A FULL STERNOTOMY AND TRANSVERSE AORTOTOMY. EXAMINATION OF THE VALVE DID NOT REVEAL ANY BREAKAGE IN THE SUTURES. THERE WAS, HOWEVER, A SMALL GAP BETWEEN THE SEWING CUFF AND THE NONCORONARY ANNULUS TISSUE SUGGESTIVE OF POSSIBLE TEARING OF THE SUTURES THROUGH THE TISSUE ALONG THIS ANNULUS . AFTER SOME DISCUSSION, DECISION WAS MADE TO REPLACE THE VALVE INSTEAD OF REPAIRING THE PARAVALVULAR LEAK. FOR THIS PURPOSE, THE VALVE WAS REMOVED. FURTHER REASON TO REMOVE THE VALVE WAS PATIENT'S HISTORY OF HIGH-GRADE FEVER. THE LVOT AND ANNULUS WERE WASHED WITH COPIOUS AMOUNTS OF ANTIBIOTIC SALINE. A 25 MM ON-X VALVE WAS NOW IMPLANTED USING RIFAMPIN DIPPED 2-0 ETHIBOND PLEDGET SUTURES. THE PATIENT WAS THEN SEPARATED FROM CARDIOPULMONARY BYPASS WITH EASE. POSTBYPASS TRANSESOPHAGEAL ECHOCARDIOGRAM CONFIRMED A WELL-FUNCTIONING PROSTHESIS WITHOUT ANY EVIDENCE OF PARAVALVULAR LEAK. THE PATIENT DID RECEIVE 1 UNIT OF PACKED RED BLOOD CELLS. HE WAS THEN TRANSFERRED TO CORONARY CARE UNIT IN SATISFACTORY AND STABLE CONDITION."

    Description of Event or Problem · 1

    ACCORDING TO OPERATIVE NOTES, "RIGHT AND LEFT VENTRICULAR FUNCTIONS WERE NORMAL. NEWLY IMPLANTED PROSTHESIS APPEARED TO BE OPENING WELL. THERE WAS, HOWEVER, MODERATE PARAVALVULAR LEAK ORIGINATING FROM A SMALL OPENING NEAR THE RIGHT AND NONCORONARY COMMISSURES. THERE WAS ALSO SUGGESTION OF A SMALL RESIDUAL LEAKS IN AT LEAST ONE OTHER SPOT ALONG THE LEFT CORONARY ANNULUS. WE THEN PROCEEDED TO EXPOSE THE AORTIC VALVE THROUGH A FULL STERNOTOMY AND TRANSVERSE AORTOTOMY. EXAMINATION OF THE VALVE DID NOT REVEAL ANY BREAKAGE IN THE SUTURES. THERE WAS, HOWEVER, A SMALL GAP BETWEEN THE SEWING CUFF AND THE NONCORONARY ANNULUS TISSUE SUGGESTIVE OF POSSIBLE TEARING OF THE SUTURES THROUGH THE TISSUE ALONG THIS ANNULUS . AFTER SOME DISCUSSION, DECISION WAS MADE TO REPLACE THE VALVE INSTEAD OF REPAIRING THE PARAVALVULAR LEAK. FOR THIS PURPOSE, THE VALVE WAS REMOVED. FURTHER REASON TO REMOVE THE VALVE WAS PATIENT'S HISTORY OF HIGHGRADE FEVER. THE LVOT AND ANNULUS WERE WASHED WITH COPIOUS AMOUNTS OF ANTIBIOTIC SALINE. A 25 MM ONX VALVE WAS NOW IMPLANTED USING RIFAMPIN DIPPED 20 ETHIBOND PLEDGETED SUTURES. THE PATIENT WAS THEN SEPARATED FROM CARDIOPULMONARY BYPASS WITH EASE. POSTBYPASS TRANSESOPHAGEAL ECHOCARDIOGRAM CONFIRMED A WELL FUNCTIONING PROSTHESIS WITHOUT ANY EVIDENCE OF PARAVALVULAR LEAK. THE PATIENT DID RECEIVE 1 UNIT OF PACKED RED BLOOD CELLS. HE WAS THEN TRANSFERRED TO CORONARY CARE UNIT IN SATISFACTORY AND STABLE CONDITION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186847 ONX AORTIC ANATOMIC EXT 27/29 HEART VALVE MECHANICAL LWQ ONX LIFE TECHNOLOGIES, INC. ONXANE27/ 29

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R