BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-X MITRAL HEART VALVE - 25 MM

    MDR report key: 5995423 · Received October 3, 2016

    Report

    Report Number
    1649833-2016-10052
    Event Type
    Death
    Date Received
    October 3, 2016
    Date of Event
    March 31, 2016
    Report Date
    October 3, 2016
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC
    Product Code
    LWQ
    UDI-DI
    00851788001273
    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. THE ON-X 614 HEART VALVE DESIGN FMEA 940816 01 REV S THOROUGHLY IDENTIFIES THE PROCESS AND PRODUCT HAZARDS FOR APPROVED INDICATIONS. EACH INDIVIDUAL HAZARD IS MITIGATED AND REDUCED AS LOW AS POSSIBLE BY DESIGN AND PROCESS. POST PRODUCTION RESIDUAL RISK IS COMMUNICATED IN THE PRODUCT'S LABELING AND INSTRUCTION FOR USE (IFU). DEATH FOLLOWING CARDIAC SURGERY IS A KNOWN POTENTIAL COMPLICATION OCCURING WITH THE USE OF PROSTHETIC VALVES AND IS NOT UNIQUE TO THE ON-X VALVE. WITHOUT RETURN OF THE VALVE, A SPECIFIC RISK CANNOT BE IDENTIFIED. REVIEW OF THE OPERATIVE NOTES DOES NOT REVEAL AN ALLEGATION OF DEFICIENCY OR A CAUSATIVE CORRELATION TO THE ON-X VALVE.

    Description of Event or Problem · 1

    IMPLANT RECOVERY CARD (IRC) RECEIVED INDICATES THAT PATIENT UNDERWENT DOUBLE VALVE SURGERY ON (B)(6) 2016 RECEIVING ONXANE-21 AND ONXM-25 INDICATED FOR SEVERE AORTIC INSUFFICIENCY AND SEVERE MITRAL REGURGITATION. PROCEDURE PERFORMED WAS "TRANSESOPHAGEAL ECHOCARDIOGRAM [TEE], MITRAL VALVE REPLACEMENT, CHORDAL SPARING (25 MM ON-X MECHANICAL VALVE), AORTIC VALVE REPLACEMENT (21 MM ON-X MECHANICAL VALVE), EXTENSIVE PERICARDIAL ADHESIOLYSIS SECONDARY TO EXTENSIVE PERICARDITIS." ADDITIONAL INFORMATION RECEIVED INDICATED THAT PATIENT DIED ON (B)(6) 2016. A PRELIMINARY AUTOPSY REPORT INDICATES THE FOLLOWING: PROVISIONAL ANATOMIC DIAGNOSES: CARDIOVASCULAR SYSTEM. STATUS POST (B)(6) 2016 AORTIC VALVE & RNLTRAL VALVE REPLACEMENT SURGERY. BOTH MITRAL & AORTIC ON-X PROSTHETIC HEART VALVES APPEAR PROPERLY POSITIONED & INTACT. SMALL EPICARDIAL ABSCESS (1 CM) AD]ACENT TO PROSTHETIC MITRAL VALVE B, HEART WITH CARDIOMEGALY (569 G). LEFT VENTRICULAR HYPERTROPHY. FOCAL SCARRING OF MYOMETRIUM SUGGESTIVE OF REMOTE INFARCT; NO ACUTE INFARCTION SEEN.. FIBRINOUS PERICARDITIS. CALCIFIC ATHEROSCLEROSIS OF CORONARY ARTERIES. PULMONARY SYSTEM. CONGESTED APPEARS TO LUNGS ,BILATERALLY (EACH LUNG 720 G). NO EVIDENCE OF ACUTE INFARCT OR PULMONARY EMBOLI. A DEFINITIVE CAUSE OF DEATH WAS NOT INDICATED. THIS REPORT IS RELEGATED TO THE ONXM-25 VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645952 ON-X MITRAL HEART VALVE - 25 MM MECHANICAL HEART VALVE LWQ ON-X LIFE TECHNOLOGIES, INC ONXM-25 00851788001273

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death| O