BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 4234155 · Received November 7, 2014

    Report

    Report Number
    9612164-2014-01438
    Event Type
    Malfunction
    Date Received
    November 7, 2014
    Date of Event
    August 19, 2014
    Report Date
    November 27, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (STENT DEFORMATION). PATIENT CONDITION AFFECTED EFFECTIVENESS OF DEVICE (LESION MORPHOLOGY - 80% STENOSIS). NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW). EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE (STENT DEFORMATION). DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (LESION MORPHOLOGY - 80% STENOSIS). UNABLE TO CONFIRM COMPLAINT (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW).

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS - DEFORMATION PROBLEM (STENT).

    Description of Event or Problem · 1

    DEVICE EVALUATION: THE DISTAL CATHETER TIP WAS FLARED. A NUMBER OF STRUTS ON THE 10TH, 11TH, 12TH, 16TH AND 17TH PROXIMAL STENT SEGMENTS WERE RAISED AND DEFORMED. THE REMAINING SEGMENTS WERE INTACT.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING AN ENDEAVOR RESOLUTE DRUG-ELUTING STENT FOR TREATMENT OF THE RCA. THE DEVICE WAS REMOVED FROM THE PACKAGING, INSPECTED AND PREPPED PRIOR TO USE WITH NO ISSUES NOTED. THE LESION WAS 80% STENOSED. THE LESION WAS PRE-DILATED THREE TIMES TO 12 ATMS WITH A 2.00 X 18 UNKNOWN BRAND BALLOON. IT WAS REPORTED THAT DUE TO THE HIGH RATE OF STENOSIS IN THE VESSEL THE DEVICE WAS UNABLE TO CROSS THE LESION AND STENT STRUTS BECAME DEFORMED. THE DEVICE WAS REMOVED AND A SECOND ENDEAVOR RESOLUTE STENT WAS USED. THIS DEVICE WAS ALSO UNABLE TO CROSS THE LESION DUE TO HIGH RATE OF STENOSIS AND THE STENT STRUTS OF THIS STENT ALSO BECAME DEFORMED. THE PHYSICIAN INDICATED THAT THE DIFFICULT LESION MORPHOLOGY/ANATOMY IMPACTED ON THE REPORTED EVENT. NO REPORTED PATIENT COMPLICATIONS OR OTHER CLINICAL SEQUELAE. 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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720322 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0007132188

    Patients

    Seq Age Sex Outcome Treatment
    1