BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3118846 · Received May 19, 2013

    Report

    Report Number
    2024168-2013-03146
    Event Type
    Injury
    Date Received
    May 19, 2013
    Date of Event
    January 1, 2002
    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
    JA
    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 EVENT ESTIMATED AS DATE OF PUBLICATION. DATE OF IMPLANT ESTIMATED AS DATE OF PUBLICATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF STENOSIS IS LISTED IN THE RX GRAFTMASTER INSTRUCTIONS FOR USE, IN THE POTENTIAL ADVERSE EFFECTS SECTION AS A POTENTIAL ADVERSE EFFECT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, 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. ARTICLE- (CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 2013, 81:713-716): LONG-TERM OUTCOME OF TRANSCATHETER POLYTETRAFLUOROETHYLENE-COVERED STENT IMPLANTATION IN A GIANT CORONARY ANEURYSM OF A CHILD WITH KAWASAKI DISEASE.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW OF THE FOLLOWING PUBLICATION: (CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 2013, 81:713-716): "LONG-TERM OUTCOME OF TRANSCATHETER POLYTETRAFLUOROETHYLENE-COVERED STENT IMPLANTATION IN A GIANT CORONARY ANEURYSM OF A CHILD WITH KAWASAKI DISEASE". DURING A REVIEW IF THIS ARTICLE, THE FOLLOWING RESULTS ARE REPORTED IN THIS ARTICLE FROM A REFERENCED ARTICLE, "RESULTS OF THE JOSTENT CORONARY STENT GRAFT IMPLANTATION IN VARIOUS CLINICAL SETTINGS: PROCEDURAL AND FOLLOW-UP RESULTS" BY GERCKEN U, LANSKY AJ, BUELLESFELD L, ET AL. FROM CATHETER CARDIOVASC INTERV 2002;56:353-360: OF 78 UNSPECIFIED JOSTENT GRAFTMASTER POLYTETRAFLUOROETHYLENE (PTFE) COVERED STENTS IMPLANTED IN 70 ADULT PATIENTS, ANGIOGRAPHIC RESTENOSIS WAS FOUND IN 31.6%, WITH RESTENOSIS PRIMARILY LOCALIZED AT THE STENT EDGE (29.8% STENT EDGE VERSUS 8.8% STENT CENTER). NO ADDITIONAL INFORMATION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220727 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other