BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2880049 · Received December 19, 2012

    Report

    Report Number
    2024168-2012-08166
    Event Type
    Death
    Date Received
    December 19, 2012
    Date of Event
    July 13, 2012
    Report Date
    December 4, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE STENT REMAINS IN THE PATIENT. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4) - INCORRECT ANATOMY. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF DEATH AND THROMBOSIS ARE A KNOWN ADVERSE EVENT AS LISTED IN THE GRAFT MASTER OTW INSTRUCTION FOR USE (IFU) IN THE POTENTIAL ADVERSE EVENTS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. IT SHOULD BE NOTED IN THE INDICATIONS FOR USE SECTION OF THE GRAFTMASTER OTW 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 LESS THAN OR QUAL TO 2.75 MM IN DIAMETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012, THE 3.5 X 19 MM GRAFTMASTER STENT WAS USED TO TREAT A PSEUDOANEURYSM AND ONGOING LEAK IN THE RIGHT PROFUNDA FEMORAL ARTERY. THE GRAFTMASTER SUCCESSFULLY TREATED THE LEAK WITH A GOOD OUTCOME. ON (B)(6) 2012, THE PATIENT DIED DUE TO DISSEMINATED INTRAVASCULAR COAGULATION/MULTI-ORGAN FAILURE. THE PHYSICIAN BELIEVES THAT THE DEATH WAS NOT DUE TO AN ISSUE WITH THE GRAFTMASTER STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT 716352

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death