BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-X AORTIC VALVE

    MDR report key: 6714634 · Received July 14, 2017

    Report

    Report Number
    1649833-2017-00055
    Event Type
    Injury
    Date Received
    July 14, 2017
    Date of Event
    December 12, 2016
    Report Date
    September 22, 2017
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE AVAILABLE INFORMATION WAS PERFORMED. THE RESULTS OF THIS EVALUATION SUGGEST THAT THIS VALVE MEETS ALL DIMENSIONAL AND FUNCTIONAL INSPECTION. INITIALLY REPORTED, AN ONXAAP-21 SN (B)(4) WAS IMPLANTED IN A (B)(6) YEAR OLD FEMALE (B)(6) 2016. THE PATIENT WAS DIAGNOSED WITH "SPONTANEOUS SUBDURAL HEMATOMA WITH 2CM MIDLINE SHIFT" ON (B)(6) 2016 (62 DAYS POST-IMPLANT). ANTICOAGULATION REPORTED TO BE WARFARIN WITH AN INR OF 1.2 ON (B)(6) 2016. THE ASPIRIN CHECKBOX WAS NOT MARKED ON THE REPORT. TREATMENT CONSISTED OF A CRANIOTOMY WITH EVACUATION OF THE SUBDURAL HEMATOMA ON (B)(6) 2016. THE EVENT WAS MARKED AS FULLY RESOLVED. A SUBDURAL HEMATOMA IS A COLLECTION OF BLOOD BETWEEN THE TOUGH COVERING OF THE BRAIN (DURA) AND THE SURFACE OF THE BRAIN. THE PRIMARY DANGER IS COMPRESSION OF THE BRAIN THAT CAN LEAD TO SEVERE SYMPTOMS INCLUDING DEATH. MOST COMMONLY THE RESULT OF TRAUMA, SUCH AS FALLS OR BLOWS TO THE HEAD, THEY ARE TERMED "SPONTANEOUS" IF A CAUSE CANNOT BE IDENTIFIED. ANTICOAGULATION INCREASES THE RISK. UNFORTUNATELY, WE DON'T HAVE ANY INFORMATION PRECEDING THE EVENT-WHETHER OR NOT THE PATIENT HAD EXPERIENCED ANY TRAUMA TO THE HEAD, AN ACUTE CIRCUMSTANCE, OR A CHRONIC CONDITION SUCH AS SLOW BLEEDING-SO WE CANNOT DETERMINE WITH ANY CERTAINTY WHETHER OR NOT THE VALVE HAD ANY ASSOCIATION TO THE EVENT. WE ALSO DO NOT HAVE SUFFICIENT INFORMATION TO ASCERTAIN THE EFFECT OF HER ANTICOAGULATION THERAPY, ALTHOUGH THE LOW INR SUGGESTS THE PATIENT HAD DISCONTINUED TAKING WARFARIN. THE INSTRUCTIONS FOR USE (IFU) FOR THE ON-X ASCENDING AORTIC PROSTHESIS LISTS HEMORRHAGE AS A POTENTIAL COMPLICATION FOR RECIPIENTS OF THE VALVE. THE OBJECTIVE PERFORMANCE CRITERIA LISTS A RATE OF MAJOR HEMORRHAGE FOR RIGID VALVE RECIPIENTS OF 1.5%/PT-YEAR [ISO 5840:2005]. ROOT CAUSE FOR THIS EVENT IS UNKNOWN BLOOD COLLECTION BETWEEN THE SURFACE OF THE BRAIN AND ITS DURA COVERING. NO FURTHER ACTION IS REQUIRED AT THIS TIME. 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

    UPDATED INFORMATION, PRODUCT CODE (ONXAAP-21), AND SERIAL NUMBER (B)(4). THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. 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 UPDATED INFORMATION, ONXAAP-21 SN (B)(4) IMPLANTED IN (B)(6) YEAR OLD FEMALE (B)(6) 2016. PATIENT DIAGNOSED WITH "SPONTANEOUS SUBDURAL HEMATOMA WITH 2CM MIDLINE SHIFT" ON (B)(6) 2016 (62 DAYS POST-IMPLANT).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, A PATIENT WITH A "HEADACHE FOUND TO HAVE SPONTANEOUS SUBDURAL HEMATOMA WITH 2CM MID-LINE SHIFT." ADDITIONAL INFORMATION INDICATED A 21MM AORTIC ON-X VALVE WAS IMPLANTED (B)(6) 2016. PATIENT COMORBIDITIES INCLUDED " ENDOCARDITIS, ALSO HAD PRIOR AORTIC VALVE AND PPM/ICD IMPLANTED." PATIENT¿S HISTORIC INR LEVELS WERE 1.2 ON (B)(6) 2016.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, A PATIENT WITH A "HEADACHE FOUND TO HAVE SPONTANEOUS SUBDURAL HEMATOMA WITH 2 CM MID-LINE SHIFT." ADDITIONAL INFORMATION INDICATED A 21 MM AORTIC ON-X VALVE WAS IMPLANTED (B)(6) 2016. PATIENT COMORBIDITIES INCLUDED " ENDOCARDITIS, ALSO HAD PRIOR AORTIC VALVE AND PPM/ICD IMPLANTED." PATIENT'S HISTORIC INR LEVELS WERE 1.2 ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495166 ON-X AORTIC VALVE HEART VALVE MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXAAP-21

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| R