BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY OTW

    MDR report key: 2982149 · Received February 28, 2013

    Report

    Report Number
    9612164-2013-00221
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    April 9, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE-FAILURE TO DELIVER THE STENT AND STENT DEFORMATION. PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE-HIGHLY CALCIFIED LESION/VESSEL. NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED- DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. EVALUATION CONCLUSION: INHERENT RISK OF PROCEDURE-FAILURE TO DELIVER THE STENT AND STENT DEFORMATION. DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION-HIGHLY CALCIFIED LESION/VESSEL. UNABLE TO CONFIRM COMPLAINT - DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. (B)(4).

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE DISTAL TIP WAS FLARED, INDICATING THAT IT MAY HAVE BEEN STUBBED DURING ADVANCEMENT. A STRUT ON THE 10TH PROXIMAL SEGMENT WAS RAISED AND DEFORMED. THE 21ST, 22ND, 23RD, 24RD AND 25TH PROXIMAL SEGMENTS WERE MISALIGNED.

    Description of Event or Problem · 1

    A RESOLUTE INTEGRITY OTW DRUG ELUTING STENT BECAME DAMAGED DURING AN ATTEMPT TO CROSS A HIGHLY CALCIFIED LESION. NO CLINICAL SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86828 RESOLUTE INTEGRITY OTW STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006162455

    Patients

    Seq Age Sex Outcome Treatment
    1