BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT CORONARY STENT GRAFT

    MDR report key: 1020732 · Received March 27, 2008

    Report

    Report Number
    2024168-2008-00225
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    April 11, 2003
    Report Date
    November 21, 2007
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MALFUNCTION- PERMANENT DAMAGE/HOSPITALIZATION/REQUIRED INTERVENTION. REPORTING RATIONALE: DELAY IN PROCEDURE REQUIRING SURGICAL INTERVENTION. DEVICE ISSUE: FAILURE TO CROSS. IT WAS REPORTED THAT THE PT HAD DEVELOPED A PERFORATION IN THE LAD AFTER A SINGLE PASS WITH ANOTHER COMPANY'S CUTTING-BALLOON. TWO ATTEMPTS WERE MADE TO DELIVER THE JOSTENT; HOWEVER, IT WOULD NOT CROSS THE LESION. A PERFUSION BALLOON WAS PLACED ACROSS THE PERFORATION AND THE PT REMAINED HEMODYNAMICALLY STABLE AND WAS TAKEN TO THE OPERATING ROOM SUITE FOR EMERGENCY BYPASS. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT CORONARY STENT GRAFT NONE MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 134161

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R| S