BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRITY RX

    MDR report key: 3042134 · Received April 9, 2013

    Report

    Report Number
    9612164-2013-00383
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 12, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ROOT CAUSE OF THE EVENT MOST LIKELY DUE TO PATIENT LESION MORPHOLOGY. CONCLUSIONS: ROOT CAUSE OF THE EVENT MOST LIKELY DUE TO PATIENT LESION MORPHOLOGY.

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO USE AN INTEGRITY RX STENT TO TREAT A LESION IN THE CX WITH 90% STENOSIS AND MODERATE CALCIFICATION AND TORTUOSITY. LESION PRE-DILATION WAS PERFORMED. APPROXIMATELY 30% STENOSIS REMAINED FOLLOWING PRE-DILATION. RESISTANCE WAS ENCOUNTERED ADVANCING THE INTEGRITY DEVICE AND FORCE USED IN THE ATTEMPT TO DELIVER THE DEVICE TO THE TARGET LESION. FOLLOWING THE ATTEMPT TO REACH THE TARGET LESION, THE STENT OBSERVED TO BE DAMAGED. NO ABNORMALITY WAS NOTED DURING PREPARATION OF THE RELEVANT DEVICE OR INSPECTION PRIOR TO USE. THE DEVICE WAS REPLACED WITH A NON-MEDTRONIC STENT. NO CLINICAL SEQUELAE WERE REPORTED. EVALUATION SUMMARY: THE DISTAL TIP WAS FLARED AND DAMAGED. THE HYPOTUBE WAS KINKED 48.5CM AND 86CM DISTAL TO THE STRAIN RELIEF AND THE DISTAL SHAFT WAS KINKED 0.9CM, 4.9CM AND 8.4CM PROXIMAL TO THE PROXIMAL INNER MARKER. STENT STRUTS ON THE 4TH PROXIMAL SEGMENT WERE RAISED AND PULLED DISTALLY. STENT STRUTS ON THE 14TH AND 15TH PROXIMAL SEGMENTS WERE SLIGHTLY MISALIGNED AND DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145463 INTEGRITY RX STENT, CORONARY MAF MEDTRONIC IRELAND 0005876403

    Patients

    Seq Age Sex Outcome Treatment
    1