BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 1961611 · Received December 27, 2010

    Report

    Report Number
    2953200-2010-02671
    Event Type
    Malfunction
    Date Received
    December 27, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 1, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): RESULTS: FAILURE TO DELIVER STENT, STENT DEFORMATION. STENT DEFORMATION OCCURRED DURING WITHDRAWAL FROM VESSEL. CONCLUSIONS: STENT DEFORMATION OCCURRED DURING WITHDRAWAL FROM VESSEL. EVALUATION SUMMARY: THE DEVICE WAS RETURNED TO MEDTRONIC FOR EVALUATION. THE STENT WAS POSITIONED ON THE BALLOON AS PER SPECIFICATION. THREE STRUTS ON THE FIRST PROXIMAL STENT SEGMENT WERE RAISED AND DEFORMED AND PULLED IN A DISTAL DIRECTION AWAY FROM THE PROXIMAL PILLOW. BLOOD RESIDUE WAS EVIDENT BETWEEN THE BALLOON FOLDS. THE DISTAL TIP WAS FRAYED.

    Description of Event or Problem · 1

    AN ENDEAVOR RESOLUTE RX DRUG-ELUTING STENT, LENGTH 12MM, DIAMETER 3 MM, WAS INTENDED TO TREAT A LESION IN A PATIENT WHICH EXHIBITED MODERATE TORTUOUSITY AND MODERATE CALCIFICATION. IT WAS REPORTED THAT THE STENT SYSTEM COULD NOT CROSS THE LESION AND, ON WITHDRAWAL, RAISED STENT STRUTS WERE NOTED. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITIES NOTED. RESISTANCE WAS EXPERIENCED DURING ATTEMPTS TO CROSS THE LESION AND DURING REMOVAL. IT WAS REPORTED THAT THE PHYSICIAN FELT THAT THE DAMAGE OCCURRED DURING WITHDRAWAL. A NEW DEVICE WAS USED TO TREAT THE LESION. NO PATIENT INJURY OCCURRED AND NO CLINICAL SEQUELAE HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0001701353

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK