BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 4112479 · Received September 24, 2014

    Report

    Report Number
    9612164-2014-01230
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 27, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (LESION MORPHOLOGY - CALCIFIED WITH 90% STENOSIS). DEFORMATION PROBLEM (CATHETER). RELATED TO OPERATIONAL CONTEXT (ATTEMPTS TO ADVANCE AND REMOVE THE DEVICE HAVE MOST LIKELY CAUSED THE DEVICE TO KINK AND DETACH). CONCLUSION RESULTS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (LESION MORPHOLOGY - CALCIFIED WITH 90% STENOSIS). RELATED TO OPERATIONAL CONTEXT (ATTEMPTS TO ADVANCE AND REMOVE THE DEVICE HAVE MOST LIKELY CAUSED THE DEVICE TO KINK AND DETACH).

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO IMPLANT ONE RESOLUTE INTEGRITY DRUG-ELUTING STENT (3.50MM X 18MM) TO A LITTLE CALCIFIED LESION IN THE RCA WITH 90% STENOSIS. RESISTANCE WAS ENCOUNTERED AND THE DEVICE COULD NOT CROSS THE LESION. DURING REMOVAL THE DOCTOR FOUND THE PROXIMAL SHAFT OF STENT WAS KINKED AND THEN BROKE OFF OUTSIDE THE PATIENT. THE SHAFT OF THE RESOLUTE INTEGRITY BROKE OFF AT ABOUT 30CM FROM PROXIMAL HUB DURING THE PROCEDURE. THE LESION HAD BEEN PRE-DILATED AND ANOTHER NON-MDT STENT HAD FAILED TO CROSS. THE PHYSICIAN CHANGED TO ANOTHER BRAND STENT TO COMPLETE THE PROCEDURE. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES NOTED. THERE WERE NO CLINICAL SEQUELAE REPORTED. DEVICE EVALUATION: THE STENT WAS POSITIONED BETWEEN THE MARKER BANDS AS PER SPECIFICATIONS. THERE WAS NO DAMAGE EVIDENT ON THE STENT. THE HYPOTUBE HAD DETACHED DISTAL TO THE STRAIN RELIEF. THE DETACHMENT SITES WERE OVAL AND JAGGED. ADDITIONAL KINKS WERE PRESENT ON THE PROXIMAL HYPOTUBE SECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593064 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006812841

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR