BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINTER LEGEND RX

    MDR report key: 3811430 · Received May 15, 2014

    Report

    Report Number
    9612164-2014-00515
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    March 6, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH - FORM FDA 3500A UF/IMPORTER RPT NUMBER: (B)(4). EVALUATION RESULTS: RELATED TO OPERATIONAL CONTEXT (PREVIOUSLY DEPLOYED STENT IN VESSEL). EVALUATION CONCLUSIONS: USER ERROR CONTRIBUTED TO EVENT (RATED BURST PRESSURE OF BALLOON EXCEEDED). OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THE EVENT (PREVIOUSLY DEPLOYED STENT IN VESSEL).

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS/CONCLUSIONS: RATED BURST PRESSURE OF BALLOON EXCEEDED. DEVICE OR PROCEDURAL IMAGES WERE NOT RETURNED FOR REVIEW. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING A CORONARY ANGIOPLASTY WITH INTRAVASCULAR ULTRASOUND STENTING TO THE LAD VESSEL, THE PHYSICIAN USED A SPRINTER LEGEND BALLOON 2.5X15 MM. THE BALLOON WAS INFLATED AT THE TARGET LESION TO 18 ATM FOR 15 SECONDS. WHEN THE BALLOON WAS REMOVED FROM THE PATIENT, IT WAS NOTED TO HAVE RUPTURED. IT IS REPORTED THE BALLOON HAD BEEN USED IN A PREVIOUSLY DEPLOYED STENT. THERE WAS A 5% DECREASE IN STENOSIS OF SVG-LAD AFTER THE BALLOON WAS USED. THE TARGET LESION WAS TREATED WITH PCI AND STENTING. NO REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291992 SPRINTER LEGEND RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX MEDTRONIC MEXICO 207838249

    Patients

    Seq Age Sex Outcome Treatment
    1 00094 YR