BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 689736 · Received March 16, 2006

    Report

    Report Number
    9616290-2006-00014
    Event Type
    Injury
    Date Received
    March 16, 2006
    Date of Event
    February 13, 2006
    Report Date
    February 15, 2006
    Manufacturer
    ABBOTT VASCULAR INSTRUMENTS DEUTSCHLAND GMBH
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 02/13/2006, THE PATIENT COMPLAINED OF CHEST PAIN AND WAS DIAGNOSED WITH ACUT MYOCARDIAL INFARCATION (MI). REPORTEDLY , THREE MONTH LATER A GRAFTMASTER STENT GRAFT WAS USED FOR A PERFORATION IN THE 'LCX" (LEFT CIRCUMFLEX) DISTAL DUE TO HEMOSTASIS." SINCE THE IMPLANTATION OF THE GRAFTMASTER STENT, IT WAS REPORTED THAT THE "PATIENTS CONDITION HAD BEEN WELL AND THERE HAS BEEN NO PARTICULAR FOLLOW-UP PRIOR TO THIS EVENT." IT WAS ALSO NOTED THAT THE PATIENT DECIDED TO STOP TAKING THE PRESCRIBED ANTI-PLATELET AGENTS ONE(1) MONTH PRIOR TO THIS EPISODE. ON 02/13/2006, AN ANGIOGRAM WAS PERFORMED WHICH REVEALED: " AN OCCLUSION DUE TO THROMBOSIS AROUND THE PROXIMAL EDGE OF THE IMPLANTED GRAFTMASTER IN THE DISTAL CIRCUMFLEX (DCS). A "THROMBECTOMY WITH CATHETER" WAS PERFORMED TO TREAT THE OCCLUSION. REPORTEDLY, "THE PATIENT'S CORONARY BLOOD FLOW MADE A RECOVERY AND THE PROCEDURE WENT WELL," IT IS UNKNOWN HOW LONG THE PATIENT STAYED IN THE HOSPITAL DURING THIS EVENT OR WHAT HIS PRESENT STATUS IS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER CORONARY STENT MAF ABBOTT VASCULAR INSTRUMENTS DEUTSCHLAND GMBH NA 228768

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| L| R