BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3900557 · Received June 27, 2014

    Report

    Report Number
    2024168-2014-04179
    Event Type
    Death
    Date Received
    June 27, 2014
    Date of Event
    May 15, 2014
    Report Date
    April 9, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PATIENT EFFECTS OF THROMBOSIS, DEATH AND CEREBROVASCULAR ACCIDENT, AS LISTED IN THE OTW GRAFTMASTER INSTRUCTIONS FOR USE (IFU), ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH THE USE OF JOSTENT CORONARY STENT GRAFT IN NATIVE CORONARY ARTERIES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING AND THE TREATMENTS APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. IT SHOULD BE NOTED THAT THE OTW GRAFTMASTER IFU, STATES: THE JOSTENT GRAFTMASTER IS INDICATED FOR USE IN THE TREATMENT OF FREE PERFORATIONS, DEFINED AS FREE CONTRAST EXTRAVASATION INTO THE PERICARDIUM, IN NATIVE CORONARY VESSELS OR SAPHENOUS VEIN BYPASS GRAFTS GREATER THAN OR EQUAL TO 2.75 MM IN DIAMETER. IN THIS CASE, IT IS UNKNOWN IF THE TREATMENT OUTSIDE THE INDICATION CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PSEUDOANEURYSM LOCATED IN THE LEFT INTERNAL CAROTID ARTERY WHICH WAS CAUSED BY AN AUTOMOBILE ACCIDENT IN (B)(6) 2013. DUE TO THE PATIENTS AGE AND TO AVOID IMPLANTING A LONGER STENT (MORE METAL) IN THE VESSEL, AN ATTEMPT WAS MADE TO USE THE SHORTER 5.0X16 MM GRAFTMASTER STENT TO COVER THE ANEURYSM; HOWEVER, IT DID NOT COMPLETELY COVER REQUIRING THE NEED FOR ANOTHER NON-ABBOTT COVERED STENT TO COMPLETELY COVER THE ANEURYSM SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. THE PATIENT PRESENTED TO THE HOSPITAL ON (B)(6) 2014, EXPERIENCING A LEFT MIDDLE CEREBRAL ARTERY TERRITORY CEREBRAL INFARCTION LEADING TO A FATAL [DEATH] THROMBOTIC COMPLICATION. A COMPUTED TOMOGRAPHY SCAN ON ARRIVAL REVEALED THE LEFT INTERNAL CAROTID ARTERY AND LEFT MIDDLE CEREBRAL ARTERY ARE HYPERDENSE CONSISTENT WITH THROMBUS. MAGNETIC RESONANCE ANGIOGRAPHY ALSO REVEALED THERE IS NONVISUALIZATION OF THE INTRACRANIAL PORTION OF THE LEFT INTERNAL CAROTID ARTERY AND LEFT MIDDLE CEREBRAL ARTERY BRANCHES CONSISTENT WITH INTRALUMINAL THROMBUS. THE PATIENT WAS ADMINISTERED ORAL MEDICATIONS ONLY AS HE WAS OUTSIDE THE TREATMENT WINDOW FOR ACUTE STROKE INTERVENTION. THE PATIENT DIED ON (B)(6) 2014. IT WAS CONFIRMED THAT THE PATIENT HAD NOT BEEN ADHERING TO THE MEDICATION REGIMEN PER HIS PHYSICIANS INSTRUCTIONS, DID NOT RENEW HIS PRESCRIPTION AND HAD STOPPED TAKING PLAVIX. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377853 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 735614

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death STENT: ENDOGRAFT