BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-X MITRAL VALVE UNKNOWN

    MDR report key: 6878582 · Received September 20, 2017

    Report

    Report Number
    1649833-2017-00069
    Event Type
    Injury
    Date Received
    September 20, 2017
    Report Date
    November 21, 2017
    Manufacturer
    ONX LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE REQUESTS TO THE SURGEON FOR ADDITIONAL CLARIFYING INFORMATION WERE MADE WITHOUT SUCCESS TO ACQUIRE THE FOLLOWING INFORMATION: THE CURRENT STATUS OF THE PATIENT, DATE OF IMPLANT, DATE OF EVENT, PATIENT¿S HISTORIC INR LEVELS UP TO THE EVENT, PROPOSED ETIOLOGY, INTERVENTIONS DONE OR PLANNED TO PERFORM, SPECIFIC VALVE SIZE AND CONFIGURATION, SERIAL NUMBER, AND INTERVENTION NOTES/MEDICAL RECORDS. NO RESPONSE WAS RECEIVED. THE MANUFACTURING RECORD FOR THE ON-X MITRAL CONFORM-X VALVE WAS NOT REVIEWED AS THE SERIAL NUMBER WAS NOT PROVIDED. THE SYSTEM COULD NOT BE QUERIED FOR POTENTIAL VALVES SENT TO THE HOSPITAL AS THE DATE OF IMPLANT WAS NOT PROVIDED. A REVIEW OF THE AVAILABLE INFORMATION WAS PERFORMED. THE VALVE IS SAID TO BE AN ONXMC-25/33 OF UNKNOWN SERIAL NUMBER AND IMPLANTED IN (B)(6) 2016 IN A (B)(6) YEAR OLD FEMALE, BUT THIS CANNOT BE CONFIRMED WITH THE INFORMATION WE HAVE AVAILABLE. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HEART FAILURE WHICH WAS ATTRIBUTED TO A PARTIALLY THROMBOSED VALVE PER ECHOCARDIOGRAPHY AND A HEART CATHETERIZATION. THE PATIENT'S INR WAS REPORTED TO BE 3.0, WHICH CONFORMS TO STANDARD-OF-CARE GUIDELINES. NORMAL CORRECTIVE ACTION WOULD BE TO REPLACE THE VALVE WITH REDO SURGERY, OR INTRODUCE THROMBOLYTIC AGENTS TO BREAK UP THE CLOT. HOWEVER, THE SURGEON WANTED TO KNOW OF ANY OTHER ALTERNATIVES DUE TO THE PATIENT'S CONDITION AND THE RISKS INVOLVED WITH THESE PRESCRIPTIONS. OUR REPRESENTATIVE POINTED OUT THAT CRYOLIFE DOES NOT MAKE RECOMMENDATIONS FOR SPECIFIC MEDICAL CASES. THIS IS A POTENTIAL THROMBOSIS OF UNKNOWN ORIGIN AND UNKNOWN OUTCOME. THE GENESIS OF THE THROMBUS IS UNKNOWN AND ITS AGE WOULD BE LESS THAN A YEAR. WHILE THROMBOSIS IS A RECOGNIZED POTENTIAL COMPLICATION ASSOCIATED WITH PROSTHETIC MITRAL VALVE REPLACEMENT [INSTRUCTIONS FOR USE], ITS OCCURRENCE IS RELATIVELY RARE. OBJECTIVE PERFORMANCE CRITERIA REPORT AN HISTORICAL THROMBOSIS INCIDENCE OF 0.8% PER VALVE-YEAR FOR ALL RIGID PROSTHETIC VALVES [ISO 5840:2005]. THERE IS NOT ENOUGH INFORMATION TO ESTABLISH THE POSITIVE IDENTITY OF THE VALVE, NOR TO ESTABLISH WHAT, IF ANY, CONTRIBUTION THE VALVE HAD TO THE DIAGNOSIS. THE IFU LISTS THROMBOSIS AS A POTENTIAL ADVERSE EVENT WITH COMPLICATIONS. ADDITIONALLY, OTHER POTENTIAL EVENTS ASSOCIATED WITH THE USE OF PROSTHETIC HEART VALVES INCLUDE HEART FAILURE, PROSTHESIS THROMBOSIS, STROKE, MYOCARDIAL INFARCTION, AND THROMBOEMBOLISM. THIS EVENT DOES NOT IDENTIFY ADDITIONAL HAZARDS OR MODIFY THE PROBABILITY AND SEVERITY OF EXISTING HAZARDS.

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS WERE MADE TO OBTAIN THE FOLLOWING CLARIFYING INFORMATION WITHOUT SUCCESS: SERIAL NUMBER, THE PATIENT¿S CURRENT STATUS, DATE OF IMPLANT AND DATE OF EVENT, PERTINENT PATIENT CO-MORBIDITIES, PATIENT¿S HISTORIC INR LEVELS UP TO THE EVENT, PROPOSED ETIOLOGY, AND PLANNED INTERVENTIONS. THE PRODUCT CODE, SERIAL NUMBER, AND DEFINITIVE DATE OF IMPLANT WERE UNAVAILABLE. AS SUCH, THE SYSTEM COULD NOT BE QUERIED FOR POTENTIAL SERIAL NUMBERS SHIPPED TO THE HOSPITAL. THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT FROM THE REP, THE SURGEON "INFORMED ME THAT IN THEIR FACILITY THEY HAVE A (B)(6) YEAR OLD FEMALE PATIENT WITH AN ON-X MITRAL CONFORM-X VALVE THAT WAS IMPLANTED (B)(6) 2016. THIS PATIENT PRESENTS WITH SYMPTOMS OF HEART FAILURE. THIS DOCTOR REPORTS THAT THE PATIENT'S INR IS 3.0 CONCLUDING THAT THE PATIENT IS WITHIN THERAPEUTIC INR RANGE." A PHONE CONVERSATION WITH THE SURGEON'S COLLEAGUE INDICATED, "WE DISCUSSED THIS PATIENT'S STATUS AND HE ASKED WHAT OPTIONS WERE AVAILABLE IN THE CASE OF A THROMBOSED VALVE. HE STATED THAT THEY HAVE DONE A HEART CATH AND ECHOCARDIOGRAPHIC INTERROGATION OF THE VALVE AND IT APPEAR TO BE RESTRICTED LEAFLET MOTION OF THE ON-X MITRAL VALVE IN THE PATIENT. WE DISCUSSED THE STANDARD OPTIONS OF THROMBOLYTIC THERAPY AND SURGICAL REINTERVENTION. [THE SURGEON] STATED THAT HE CONSULTED WITH COLLEAGUES WHO HAD STATED THE SAME OPTIONS FOR COURSE OF ACTION WITH THIS PATIENT. [THE SURGEON] STATED THAT THEY DID NOT FEEL THAT IT WAS WARRANTED TO ATTEMPT THROMBOLYTIC THERAPY AND BECAUSE OF THIS PATIENT'S LARGE BMI, SURGICAL INTERVENTION IS NOT WARRANTED."

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT FROM THE REP, THE SURGEON "INFORMED ME THAT IN THEIR FACILITY THEY HAVE A (B)(6) FEMALE PATIENT WITH AN ON-X MITRAL CONFORM-X VALVE THAT WAS IMPLANTED (B)(6) 2016. THIS PATIENT PRESENTS WITH SYMPTOMS OF HEART FAILURE. THIS DOCTOR REPORTS THAT THE PATIENT'S INR IS 3.0 CONCLUDING THAT THE PATIENT IS WITHIN THERAPEUTIC INR RANGE." A PHONE CONVERSATION WITH THE SURGEON'S COLLEAGUE INDICATED, "WE DISCUSSED THIS PATIENT'S STATUS AND HE ASKED WHAT OPTIONS WERE AVAILABLE IN THE CASE OF A THROMBOSED VALVE. HE STATED THAT THEY HAVE DONE A HEART CATH AND ECHOCARDIOGRAPHIC INTERROGATION OF THE VALVE AND IT APPEAR TO BE RESTRICTED LEAFLET MOTION OF THE ON-X MITRAL VALVE IN THE PATIENT. WE DISCUSSED THE STANDARD OPTIONS OF THROMBOLYTIC THERAPY AND SURGICAL REINTERVENTION. [THE SURGEON] STATED THAT HE CONSULTED WITH COLLEAGUES WHO HAD STATED THE SAME OPTIONS FOR COURSE OF ACTION WITH THIS PATIENT. [THE SURGEON] STATED THAT THEY DID NOT FEEL THAT IT WAS WARRANTED TO ATTEMPT THROMBOLYTIC THERAPY AND BECAUSE OF THIS PATIENT'S LARGE BMI, SURGICAL INTERVENTION IS NOT WARRANTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660886 ON-X MITRAL VALVE UNKNOWN HEART-VALVE, MECHANICAL LWQ ONX LIFE TECHNOLOGIES, INC. ONXM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening| O