BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3092655 · Received May 3, 2013

    Report

    Report Number
    2024168-2013-02774
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    February 22, 2013
    Report Date
    April 19, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. DATE OF IMPLANT ESTIMATED AS DATE OF PUBLICATION. DATE ARTICLE REVIEWED. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF THROMBOSIS AND STENOSIS ARE LISTED IN THE RX GRAFTMASTER INSTRUCTIONS FOR USE AS POTENTIAL ADVERSE EFFECTS. 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.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW OF THE FOLLOWING PUBLICATION: (CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 2013, 81:717-718): EDITORIAL COMMENT: "CORONARY STENT GRAFT: 'A DEVICE IN NEED IS A DEVICE". IT WAS REPORTED THAT THE EVENT INVOLVING AN (B)(6) MALE WHO PRESENTED WITH A GIANT RIGHT CORONARY ARTERY (RCA) ANEURYSM DUE TO KAWASAKI DISEASE AND RECEIVED TWO JOSTENT GRAFTMASTER COVERED STENT SYSTEMS (REPORTED IN INCIDENT (B)(4)) PROVIDES AN OPPORTUNITY FOR THE DISCUSSION OF THE USE OF JOSTENT GRAFTMASTER DEVICES TO TREAT EMERGENT CORONARY ARTERY ANEURYSMS AS AN ALTERNATIVE TO SURGICAL BYPASS GRAFTING. IN THIS EDITORIAL, THE FOLLOWING GENERAL COMMENTS REGARDING THE USE OF JOSTENT GRAFTMASTER DEVICES WERE EXPRESSED: COVERED STENT GRAFTS (CSG) HAVE BEEN ASSOCIATED WITH HIGHER ACUTE AND SUBACUTE STENT THROMBOSIS RATES AS THESE DEVICES DO NOT ENDOTHELIALIZE ADEQUATELY; CSGS HAVE ALSO BEEN ASSOCIATED WITH A HIGHER RESTENOSIS RATE. NO ADDITIONAL INFORMATION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194959 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other