BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3781664 · Received April 30, 2014

    Report

    Report Number
    9612164-2014-00465
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    February 28, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: PACKAGE MISLABELED. EVALUATION CONCLUSIONS: DEVICE WAS OUT OF SPECIFICATION IN A MANNER THAT RELATES TO EVENT (LABELLING ISSUE) LABELING RELATED. (B)(4).

    Description of Event or Problem · 1

    A RESOLUTE INTEGRITY 2.50 X 12 MM DRUG ELUTING STENT WAS INTENDED TO BE USED TO TREAT A PATIENT. ON INSPECTION IT WAS NOTED THAT THE BOX AND HUB OF THE SHAFT REFERENCED A 2.50 X 12 MM SIZE BUT THE COMPLIANCE CHART ATTACHED TO THE HOOP REFERENCED A 2.25 X 12 MM SIZE. THE DEVICE WAS NOT USED IN THE PATIENT. A NON-MEDTRONIC DEVICE SIZE 2.25 X 8MM WAS USED TO TREAT THE LESION. NO REPORTED PATIENT COMPLICATIONS.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE DEVICE WAS RETURNED PARTIALLY IN THE HOOP INSIDE THE PRODUCT SHELF CARTON. THE COMPLIANCE CHART ATTACHED TO THE PROTECTIVE HOOP WAS FOR A 2.25MM DIAMETER STENT BUT THE LUER AND PRODUCT SHELF CARTON REFERENCED A 2.5MM DIAMETER STENT. THE HYPOTUBE WAS SEVERELY KINKED. NO FURTHER DAMAGE WAS NOTED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260030 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006531382

    Patients

    Seq Age Sex Outcome Treatment
    1