BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 3150465 · Received June 6, 2013

    Report

    Report Number
    2024168-2013-03526
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 7, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT ESTIMATED AS DATE OF PUBLICATION. DATE OF IMPLANT ESTIMATED. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF RE-STENOSIS IS LISTED IN THE RX GRAFTMASTER INSTRUCTIONS FOR USE 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 THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW OF THE FOLLOWING PUBLICATION FROM THE JOURNAL OF INVASIVE CARDIOLOGY 2013; 25:E93-E95): "A CORONARY PSEUDOANEURYSM WITHIN A RESTENOTIC STENT TREATED BY IMPLANTATION OF A PERICARDIUM-COVERED STENT AND DRUG-ELUTING BALLOON." IT WAS REPORTED THAT A GENERAL COMMENT WAS MADE REGARDING THE GENERAL USE OF JOSTENT GRAFTMASTER POLYTETRAFLUOROETHYLENE (PTFE) COVERED STENTS: PTFE-COVERED STENTS EXHIBIT A HIGH RATE OF RESTENOSIS, OCCURRING IN ROUGHLY 30% OF THE CASES, MAINLY AT THE STENT EDGES. NO ADDITIONAL INFORMATION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249656 JOSTENT GRAFTMASTER CORONARY STENT GRAFT MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other