BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR RESOLUTE RX

    MDR report key: 3895933 · Received June 26, 2014

    Report

    Report Number
    9612164-2014-00677
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 23, 2014
    Report Date
    October 17, 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

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (FAILURE TO DELIVER STENT AND STENT DEFORMATION). PATIENT CONDITION AFFECTED EFFECTIVENESS OF THE DEVICE (THE LESION HAD SEVERE CALCIFICATION, 90% STENOSIS AND MODERATE TORTUOSITY. THE PHYSICIAN REPORTED THAT THE ISSUE WAS DUE TO THE PATIENT¿S LESION MORPHOLOGY). NO RESULTS AVAILABLE SINCE NO EVALUATION WAS PERFORMED (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW). DEVICE NOT RETURNED. EVALUATION CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE (FAILURE TO DELIVER STENT AND STENT DEFORMATION). DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION DEVICE (THE LESION HAD SEVERE CALCIFICATION, 90% STENOSIS AND MODERATE TORTUOSITY. THE PHYSICIAN REPORTED THAT THE ISSUE WAS DUE TO THE PATIENT¿S LESION MORPHOLOGY). UNABLE TO CONFIRM COMPLAINT (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW). (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: DEFORMATION ISSUE.

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO DEPLOY AN ENDEAVOR RESOLUTE 2.75 X 30MM DRUG ELUTING STENT. THE TARGET LESION WAS IN THE PROXIMAL CX. THE LESION HAD SEVERE CALCIFICATION AND 90% STENOSIS AND THE VESSEL TORTUOSITY WAS MODERATE. LESION PRE-DILATION WAS PERFORMED. THE PHYSICIAN REPORTED THAT RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE ENDEAVOR RESOLUTE DEVICE AND THE STENT WAS DAMAGED WHILE IT WAS PASSING THE LESION. IT WAS REPORTED THAT THE PHYSICIAN BELIEVES THAT THE ISSUE WAS DUE TO THE PATIENT'S LESION MORPHOLOGY. FURTHER PRE-DILATION WAS PERFORMED AND ANOTHER STENT WAS USED TO TREAT LESION SUCCESSFULLY. THE ENDEAVOR RESOLUTE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ABNORMALITIES NOTED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: ANALYSIS OF THE RETURNED DEVICE SHOWED THE STENT TO BE DAMAGED. THERE WAS A KINK ON THE TRANSITION SHAFT AT 37.5CM FROM THE TIP OF THE DEVICE.THE 5TH, 6TH AND 7TH PROXIMAL SEGMENT HAD RAISED AND STRETCHED STRUTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374720 ENDEAVOR RESOLUTE RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006915996

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR