BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 2882938 · Received December 21, 2012

    Report

    Report Number
    9612164-2012-01823
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 26, 2012
    Report Date
    January 8, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS AND CONCLUSIONS: (TARGET LESION EXHIBITED EXCESSIVE TORTUOSITY, SEVERE CALCIFICATION AND 80% STENOSIS). (FORCE USED IN AN EFFORT TO ADVANCE AND WITHDRAW DEVICE). (STENT DAMAGE, FAILURE TO DELIVER THE STENT).

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO DELIVER A 4.0 X 22 MM RESOLUTE INTEGRITY RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO TREAT A LESION THE CX, AT THE LOCATION WHERE A PREVIOUS BY-PASS GRAFT HAD BEEN IMPLANTED. THE TARGET LESION EXHIBITED EXCESSIVE TORTUOSITY, SEVERE CALCIFICATION AND 80% STENOSIS. LESION PRE-DILATION WAS PERFORMED. A 40% STENOSIS REMAINED FOLLOWING PRE-DILATION. IT WAS REPORTED THAT THE RESOLUTE INTEGRITY DEVICE COULD NOT CROSS THE LESION DUE TO THE TORTUOSITY OF THE VESSEL AND THE SEVERE CALCIFICATION. FORCE WAS USED IN AN EFFORT TO ADVANCE THE DEVICE TO THE TARGET LESION AND TO WITHDRAW THE DEVICE FOLLOWING THE FAILED DELIVERY ATTEMPT. THE STENT OF THE DEVICE WAS REPORTED TO BE DAMAGED ON REMOVAL. A 3.5 X 18 MM AND A 3.0 X 12 MM RESOLUTE INTEGRITY STENT WERE USED TO TREAT THE LESION. PATIENT STATUS POST PROCEDURE WAS REPORTED TO BE EXCELLENT AND NO CLINICAL SEQUELAE WERE REPORTED. THE DEVICE HAD BEEN INSPECTED PRIOR TO USE WITH NO ABNORMALITIES NOTED.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE DISTAL TIP WAS FLARED AND DAMAGED. THERE WERE NUMEROUS KINKS ALONG THE HYPOTUBE SHAFT. A GAP WAS EVIDENT BETWEEN THE PROXIMAL PILLOW AND STENT. THE 1ST SIX DISTAL SEGMENTS WERE BUNCHED AND DEFORMED. THE 7TH, 8TH, 9TH AND 10TH DISTAL SEGMENTS WERE PINCHED AND PARTIALLY FLATTENED. THE REMAINING SEGMENTS WERE INTACT. PROCEDURAL IMAGES PROVIDED FOR REVIEW CONFIRMED THE TORTUOUS NATURE OF THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006124578

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR