BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 4100662 · Received September 19, 2014

    Report

    Report Number
    9612164-2014-01218
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 4, 2014
    Report Date
    October 31, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE ¿ (STENT DEFORMATION). PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (LESION MORPHOLOGY) ¿ 100% STENOSIS, MODERATE CALCIFICATION AND MODERATE VESSEL TORTUOSITY. FAILURE TO FOLLOW INSTRUCTIONS ¿ (NC SPRINTER BALLOON INFLATED BEYOND RBP). (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - DEVICE NOT PROVIDED FOR REVIEW. DEVICE NOT RETURNED FOR EVALUATION. EVALUATION CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (LESION MORPHOLOGY) ¿ 100% STENOSIS, MODERATE CALCIFICATION AND MODERATE VESSEL TORTUOSITY. INHERENT RISK OF PROCEDURE ¿ (STENT DEFORMATION). FAILURE TO FOLLOW INSTRUCTIONS ¿ (NC SPRINTER BALLOON INFLATED BEYOND RBP). UNABLE TO CONFIRM COMPLAINT ¿ (DEVICE NOT RETURNED FOR EVALUATION). (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN DELIVERED ONE ENDEAVOR RESOLUTE DRUG-ELUTING STENT TO A MODERATELY CALCIFIED LESION IN THE LAD WITH 100% STENOSIS AND MODERATE VESSEL TORTUOSITY BUT RESISTANCE WAS NOTED AND THE STENT DEFORMED AT THE LESION. STENT WAS POST DILATED WITH A BALLOON 22ATMS, 3 TIMES. LESION HAD BEEN PRE-DILATED TO 14ATM. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES NOTED. NO OTHER CLINICAL SEQUELAE WERE REPORTED FOR THIS EVENT. IMAGE REVIEW THE PROCEDURAL STILL IMAGE SHOWS A DEPLOYED STENT IN THE MID-LAD VESSEL. STENT DEFORMATION CAN BE CONFIRMED FROM THE IMAGE. IT APPEARS LIKELY THAT THE OVER INFLATION WITH THE POST-DILATION BALLOON COUPLED WITH THE TORTUOSITY AND CALCIFICATION IN THE VESSEL HAVE MOST LIKELY CONTRIBUTED TO THE STENT DEFORMATION. ¿PLEASE NOTE THAT THIS DEVICE (ENDEAVOR RESOLUTE) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT (RESOLUTE INTEGRITY).¿

    Description of Event or Problem · 1

    IMAGE REVIEW THE IMAGES CONFIRM A TOTAL OCCLUSION IN THE LAD VESSEL. THE AREA OF TREATMENT IS ON A TORTUOUS BEND IN THE MID LAD VESSEL. THE VESSEL IS PRE-DILATED HOWEVER THEY APPEAR TO HAVE HAD LITTLE IMPACT ON IMPROVING THE VESSEL LUMINAL DIAMETER. THE ERES27530X STENT IS POSITIONED AND DEPLOYED ON A BEND IN THE MID LAD VESSEL. STENT SEGMENT DEFORMATION IS EVIDENT IN THE MID SEGMENTS. MULTIPLE POST-DILATIONS ARE PERFORMED HOWEVER THE STENT REMAINS DEFORMED IN THE MID SEGMENTS. BASED ON THE IMAGES IT APPEARS THAT THE MORPHOLOGY OF THE VESSEL COUPLED WITH THE MULTIPLE POST-DILATIONS HAVE CONTRIBUTED TO THE STENT DEFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582301 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0007112463

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR