BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    MDR report key: 1840614 · Received September 17, 2010

    Report

    Report Number
    2953200-2010-01766
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 19, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (FAILURE TO DELIVER STENT, STENT DEFORMATION), (HIGHLY CALCIFIED, 95% STENOSIS). CONCLUSIONS: (HIGHLY CALCIFIED, 95% STENOSIS). EVAL SUMMARY: THE DEVICE WAS RETURNED FOR EVAL. THE STENT WAS POSITIONED ON THE BALLOON AND PER SPECIFICATION. THE 1ST, 2ND, 6TH, 7TH AND 8TH DISTAL SEGMENTS WERE PINCHED AND KINKED. TWO STRUTS ON 14TH SEGMENT WERE RAISED AND PULLED DISTALLY. SEGMENTS 19, 20 AND 21 WERE SLIGHTLY RAISED. A PROTECTIVE SHEATH COULD NOT BE PLACED OVER THE RETURNED STENT DUE TO THE RAISED MIDDLE STENT STRUTS.

    Description of Event or Problem · 1

    A 3.00MM DIAMETER X 24MM LENGTH ENDEAVOR RESOLUTE RX DRUG-ELUTING STENT WAS INSERTED INTO A PT FOR TREATMENT OF HIGHLY CALCIFIED PROXIMAL OSTIAL RCA LESION. THE LESION IS REPORTED TO HAVE EXHIBITED 95% STENOSIS. THE LESION HAD BEEN PRE-DILATED 5 TIMES, WITH 2.00MM X 20MM OTHER BRAND BALLOON, WITH 90% STENOSIS REMAINING. IT WAS CONFIRMED THAT THE ENDEAVOR RESOLUTE RX DEVICE HAD BEEN INSPECTED PRIOR TO USE, WITH NO ANOMALIES NOTED. IT WAS REPORTED THAT THE STENT WOULD NOT ADVANCE THROUGH THE LESION. AFTER REMOVING THE DEVICE FROM THE PT, IT WAS REPORTED THAT THE DEVICE LOOKED DAMAGED. A 3.00 X 18MM ENDEAVOR RESOLUTE RX DRUG-ELUTING STENT WAS SUCCESSFULLY IMPLANTED. PT STATUS POST PROCEDURE WAS REPORTED TO BE OKAY. NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0003279799

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK