BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVE GFX OTW CORONARY STENT SYSTEM

    MDR report key: 217729 · Received April 7, 1999

    Report

    Report Number
    2953200-1999-00033
    Event Type
    Death
    Date Received
    April 7, 1999
    Date of Event
    March 6, 1999
    Report Date
    March 8, 1999
    Manufacturer
    ARTERIAL VASCULAR ENGINEERING, INC.
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 3.0MM DIAMETER X 30MM LENGTH AVE GFX STENT WAS INSERTED INTO THE RIGHT CORONARY ARTERY AFTER PREDILATION WITH A 3.0MM DIAMETER PTCA BALLOON. AFTER DEPLOYMENT OF THE STENT AND INFLATION OF THE STENT DELIVERY SYSTEM BALLOON TO 10 ATMS., WHICH SLIGHTLY EXCEEDS "RATED" BURST PRESSURE OF 9 ATMS., THE BALLOON WAS DEFLATED TO "NEGATIVE PRESSURE". RESISTANCE WAS THEN NOTICED BY THE DOCTOR DURING REMOVAL OF THE STENT DELIVERY BALLOON FROM THE STENT AND EXCESSIVE FORCE WAS REQUIRED TO REMOVE THE STENT DELIVERY SYSTEM FROM THE STENT. THE BALLOON MATERIAL BECAME UNSTABLE. IT WAS NOT DETERMINED IF THE PATIENT WAS A SURGICAL CANDIDATE BECAUSE OF SEVERE PERIPHERAL VASCULAR DISEASE. APPROX 10 DAYS FOLLOWING THE STENT PROCEDURE. THE PATIENT EXPIRED. THE CAUSE OF DEATH HAS NOT BEEN DISCLOSED TO AVE FROM THE USER FACILITY. NO FURTHER INFORMATION IS AVAILABLE FROM THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVE GFX OTW CORONARY STENT SYSTEM Implant OVER-THE-WIRE CORONARY STENT SYSTEM MAF ARTERIAL VASCULAR ENGINEERING, INC. NA 8H31E03

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death