BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 2240072 · Received September 9, 2011

    Report

    Report Number
    2024168-2011-06212
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 15, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF THROMBOSIS, AS LISTED IN THE INSTRUCTIONS FOR USE, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 5.0 X 16 MM GRAFTMASTER STENT WAS IMPLANTED TO TREAT A PERFORATION IN THE MID RIGHT CORONARY ARTERY (RCA). IT WAS IMPLANTED WITHOUT ISSUE, TO SUCCESSFULLY SEAL THE PERFORATION. HOWEVER, POST STENT IMPLANTATION, ACUTE CLOSURE OF THE VESSEL WAS NOTED WITH THROMBOSIS. ADDITIONAL BALLOONING WAS PERFORMED TO TREAT THE THROMBOSIS. NO FURTHER PATIENT EFFECTS WERE REPORTED. 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 590012

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention