BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-X AORTIC HEART VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER - 27/29MM

    MDR report key: 5956021 · Received September 16, 2016

    Report

    Report Number
    1649833-2016-00013
    Event Type
    Injury
    Date Received
    September 16, 2016
    Date of Event
    December 7, 2015
    Report Date
    October 4, 2016
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN 2016, ON-X TECHNOLOGIES INCORPORATED (ON-X) BECAME A WHOLLY OWNED SUBSIDIARY OF CRYOLIFE, INC. (CRYOLIFE). A RETROSPECTIVE REVIEW OF THE ON-X COMPLAINT SYSTEM WAS PERFORMED TO IDENTIFY ANY AREAS REQUIRING ADDITIONAL ACTION AND TO APPROPRIATELY ASSIMILATE THE ON-X PROCESS INTO THE CRYOLIFE QUALITY MANAGEMENT SYSTEM. IN AN ABUNDANCE OF CAUTION THIS MDR IS BEING REPORTED TO SATISFY REGULATORY REPORTING OBLIGATIONS. ENDOCARDITIS IS A KNOWN POTENTIAL COMPLICATIONS LISTED IN THE INSTRUCTIONS FOR USE (IFU). FURTHERMORE, THIS COMPLICATION IS NOT UNIQUE TO THE ON-X DEVICE AND IS ASSOCIATED WITH ALL MECHANICAL HEART VALVES. ALL OBSERVED RISKS ARE MITIGATED IN THE LABELING AND IFU. NO FURTHER ACTION REQUIRED.

    Additional Manufacturer Narrative · 1

    IN 2016, ON-X TECHNOLOGIES INCORPORATED (ON-X) BECAME A WHOLLY OWNED SUBSIDIARY OF CRYOLIFE, INC. (CRYOLIFE). A RETROSPECTIVE REVIEW OF THE ON-X COMPLAINT SYSTEM WAS PERFORMED TO IDENTIFY ANY AREAS REQUIRING ADDITIONAL ACTION AND TO APPROPRIATELY ASSIMILATE THE ON-X PROCESS INTO THE CRYOLIFE QUALITY MANAGEMENT SYSTEM. IN AN ABUNDANCE OF CAUTION THIS MDR IS BEING REPORTED TO SATISFY REGULATORY REPORTING OBLIGATIONS. ENDOCARDITIS IS A KNOWN POTENTIAL COMPLICATIONS LISTED IN THE INSTRUCTIONS FOR USE (IFU). FURTHERMORE, THIS COMPLICATION IS NOT UNIQUE TO THE ON-X DEVICE AND IS ASSOCIATED WITH ALL MECHANICAL HEART VALVES. ALL OBSERVED RISKS ARE MITIGATED IN THE LABELING AND IFU. NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    IMPLANT RECOVERY CARDS RECEIVED INDICATE THAT PATIENT IMPLANTED WITH ONXACE-27/29 ON 01/07/2013 AND REQUIRED INTERVENTION/EXPLANT ON (B)(6) 2015 WITH REPLACEMENT VIA ONXANE-25. MEDICAL RECORDS INDICATE THE FOLLOWING: PREOPERATIVE DIAGNOSIS: ENDOCARDITIS OF AN ASCENDING AORTIC GRAFT ALONG WITH AO11IC VALVE ENDOCARDITIS WITH STAPHYLOCOCCUS SPECIES. POSTOPERATIVE DIAGNOSIS: PUMLENT MEDIASTINITIS WITH FRANK PURNLENCE AROUND THE ASCENDING AORTIC GRAFT, ENDOCARDITIS OF THE ASCENDING AORTIC GRAFT, ENDOCARDITIS OF PROSTHETIC VALVE. PROCEDURE : REDO STERNOTOMY, EXCISION OF ASCENDING AORTIC GRAFT REPLACEMENT WITH A CRYOPRESERVED ASCENDING AORTIC GRAFT, REDO AORTIC VALVE REPLACEMENT WITH A 25 NUN ONYX VALVE, SERIAL #(B)(4), INTRAOPERATIVE TEE, 22 MODIFIER FOR EXTREMELY DIFFICULT CASE DUE TO SEVERE ADHESIONS, RUPTURE OF THE INFERIOR CURVE OF THE ARCH, AND IMMOBILITY OF THE BASE OF THE HEART. TOTAL OPERATIVE TIME = APPROXIMATELY 10 HOURS.

    Description of Event or Problem · 1

    IMPLANT RECOVERY CARDS RECEIVED INDICATE THAT PATIENT IMPLANTED WITH ONXACE-27/29 ON (B)(6) 2013 AND REQUIRED INTERVENTION/EXPLANT ON (B)(6) 2015 WITH REPLACEMENT VIA ONXANE-25. MEDICAL RECORDS INDICATE THE FOLLOWING: PREOPERATIVE DIAGNOSIS: ENDOCARDITIS OF AN ASCENDING AORTIC GRAFT ALONG WITH AO11IC VALVE ENDOCARDITIS WITH STAPHYLOCOCCUS SPECIES. POSTOPERATIVE DIAGNOSIS: PUMLENT MEDIASTINITIS WITH FRANK PURNLENCE AROUND THE ASCENDING AORTIC GRAFT, ENDOCARDITIS OF THE ASCENDING AORTIC GRAFT, ENDOCARDITIS OF PROSTHETIC VALVE. PROCEDURE: REDO STERNOTOMY, EXCISION OF ASCENDING AORTIC GRAFT REPLACEMENT WITH A CRYOPRESERVED ASCENDING AORTIC GRAFT, REDO AORTIC VALVE REPLACEMENT WITH A 25 NUN ONYX VALVE, SERIAL #(B)(4), INTRAOPERATIVE TEE, 22 MODIFIER FOR EXTREMELY DIFFICULT CASE DUE TO SEVERE ADHESIONS, RUPTURE OF THE INFERIOR CURVE OF THE ARCH, AND IMMOBILITY OF THE BASE OF THE HEART. TOTAL OPERATIVE TIME = APPROXIMATELY 10 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607995 ON-X AORTIC HEART VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER - 27/29MM MECHANICAL HEART VALVE LWQ ON-X LIFE TECHNOLOGIES, INC ONXACE-27/29

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| O