BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 5305885 · Received December 17, 2015

    Report

    Report Number
    9612164-2015-01894
    Event Type
    Malfunction
    Date Received
    December 17, 2015
    Date of Event
    November 27, 2015
    Report Date
    November 27, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: NO DAMAGE TO THE DISTAL TIP. THE STENT WAS POSITIONED BETWEEN THE INNER SHAFT MARKERS AS PER SPECIFICATION REQUIREMENTS. A NUMBER OF STRUTS ON THE 15TH AND 16TH DISTAL STENT SEGMENTS WERE SLIGHTLY RAISED AND MISALIGNED . ALTHOUGH STENT PASSED OD MEASUREMENT SPECIFICATION THE FAILURE MODE IS DETERMINED BY VISUAL INSPECTION. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO USE AN ENDEAVOR RESOLUTE STENT. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITIES NOTED. NOTHING UNUSUAL WAS NOTED DURING DEVICE PREPARATION. THE TARGET LESION IN THE LM HAD SEVERE TORTUOSITY, SEVERE CALCIFICATION AND 90% STENOSIS. LESION WAS PRE-DILATED 3 TIMES AT 12 ATM铮 60% STENOSIS REMAINED AFTER PRE-DILATION. RESISTANCE WAS NOTED WHILE ADVANCING THE DEVICE TO THE LESION. IT WAS REPORTED THAT THE ENDEAVOR RESOLUTE STENT WAS NOTED TO BE DEFORMED WHEN IT WAS BEING ADVANCED TO THE LESION. DEVICE WAS REMOVED FROM THE PATIENT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PHYSICIAN DETERMINED THAT THIS WAS A QUALITY ISSUE. THE PHYSICIAN THINKS THE DEVICE 'IS DIFFERENT WITH DESCRIPTION'. NO PATIENT INJURY REPORTED, PATIENT IS WELL NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835764 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0007581475

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR