BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3931270 · Received July 14, 2014

    Report

    Report Number
    9612164-2014-00913
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 11, 2014
    Report Date
    August 20, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: (INHERENT RISK OF PROCEDURE, STENT DEFORMATION). (PATIENTS CONDITION AFFECTED THE EFFECTIVENESS OF THE DEVICE, 99% CALCIFIED LESION). (DEFORMATION PROBLEM). NO RESULTS AVAILABLE SINCE NO EVALUATION WAS PERFORMED). (NONE, NO DEVICE RECEIVED FOR EVALUATION). EVALUATION CONCLUSION: (DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENTS CONDITION, 99% CALCIFIED LESION). (KNOWN INHERENT RISK OF PROCEDURE, STENT DEFORMATION). (MATERIAL DEFORMATION); (INACCURATE DELIVERY); (NO CONSEQUENCE OR IMPACT TO THE PATIENT). (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN ATTEMPTED TO TREAT LESION IN THE PDA USING A RESOLUTE INTEGRITY STENT. THE SVG EXHIBITED 99% STENOSIS (SVG TO PAD-99% OSTIAL CALCIFIED LESION), WITH UNKNOWN TORTUOSITY/ CALCIFICATION. NO ISSUES WERE NOTED WITH THE DEVICE PRIOR TO USE. IT WAS REPORTED THAT THE STENT BECAME FLARED WHILE PASSING THROUGH THE SVG TO PDA. AN ATTEMPT WAS MADE TO REMOVE THE SDS AND THE GUIDE CATHETER AS A SINGLE UNIT FROM THE PATIENT WHEN THE FLARING WAS NOTED HOWEVER STENT COULD NOT BE RETRACTED BACK INTO THE SHEATH. IT CANNOT BE CONFIRMED IF POSITIVE PRESSURE WAS APPLIED TO THE STENT DURING ADVANCEMENT TOWARDS THE TARGET LESION. IT WAS REPORTED THAT STENT WAS DEPLOYED IN THE LEFT RADIAL ARTERY. NO PATIENT COMPLICATIONS WERE REPORTED. LESION WAS TREATED WITH A COMPETITOR STENT.

    Description of Event or Problem · 1

    CINE IMAGE REVIEW: REVIEW OF PROCEDURAL IMAGES CONFIRM THAT THE STENT BECAME FLARED WHILE PASSING THROUGH THE SVG TO THE PDA. THE PATIENTS LESION MORPHOLOGY APPEARS POOR IN THE VESSEL. IT APPEARS THAT THE STENT WAS SLIGHTLY INFLATED PRIOR TO BEING IN THE CORRECT POSITION. THE STENT THEN APPEARED TO BE IMPLANTED IN THE LEFT RADIAL ARTERY AND THE STENT DID NOT EXPAND UNIFORMLY POSSIBLY DUE TO THE PRESENCE OF CALCIFICATION IN THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411138 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0007012108

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR