BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS VASCULAR SD

    MDR report key: 841695 · Received April 26, 2007

    Report

    Report Number
    6000093-2007-00852
    Event Type
    Malfunction
    Date Received
    April 26, 2007
    Date of Event
    February 5, 2007
    Report Date
    March 28, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS VERIFIED THE DIFFICULTY AS STATED IN THE COMPLAINT. THE DELIVERY DEVICE WITHOUT THE DEPLOYED STENT WAS RECEIVED IN GOOD CONDITION, WITH NO DAMAGE OBSERVED, AND WITH THE BALLOON IN A SEMI INFLATED STATE. MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL REVEALED A PINHOLE TEAR IN THE BALLOON WALL LOCATED 1.2 CENTIMETERS PROXIMAL FROM THE DISTAL TIP. MICROSCOPIC EXAMINATION OF THE AREA SURROUNDING THE TEAR DID NOT REVEAL ANY IRREGULARITIES IN THE BALLOON MATERIAL, WHICH WOULD HAVE CONTRIBUTED TO THE FORMATION OF THE TEAR. NO ISSUES WERE NOTED WITH THE BALLOON MATERIAL OR WITH THE RO MARKERS THAT COULD HAVE CONTRIBUTED TO THE LEAK. THE MFG RECORD FOR BATCH 9121775 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECS. THERE ARE NO SIMILAR COMPLAINTS OF THIS NATURE RELATED TO THIS BATCH NUMBER. THIS WILL CONTINUE TO BE MONITORED FOR FUTURE TRENDS. THE ROOT CAUSE OF THE BALLOON TEAR DIFFICULTIES EXPERIENCED DURING THE PROCEDURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS APPROVED ON 3/28/07. IT WAS REPORTED THAT DURING A DIRECT STENTING TREATMENT PROCEDURE IN THE LEFT RENAL ARTERY, BALLOON INFLATION DIFFICULTIES OCCURRED. USING RADIOGRAPHY, THE PHYSICIAN PLACED THE STENT WITHOUT DIFFICULTY. WHILE ATTEMPTING TO POST-DILATE THE STENT, IT WAS NOT POSSIBLE TO INFLATE THE BALLOON TO MORE THAN 4 ATMS ON THE FIRST INFLATION. LEAKAGE OF CONTRAST MEDIUM OCCURRED AND THE BALLOON WAS WITHDRAWN. THE PHYSICIAN WAS ABLE TO POST-DILATE THE STENT WITH A DIFFERENT BALLOON. THERE WERE NO REPORTED PT COMPLICATIONS AND THE CURRENT PT CONDITION IS REPORTED AS "WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS VASCULAR SD PREMOUNTED BALLOON EXPANDABLE STENT SYSTEM FGE BOSTON SCIENTIFIC CORP. NA 9121775

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR