BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX CORONARY STENT SYSTEM

    MDR report key: 2231136 · Received August 26, 2011

    Report

    Report Number
    9612164-2011-01039
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 29, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: ROOT CAUSE OF REPORTED DISLODGEMENT CANNOT BE DETERMINED. FAILURE TO DELIVER THE STENT, STENT EMBOLISM. METHODS: FILM. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN. ROOT CAUSE OF REPORTED DISLODGEMENT CANNOT BE DETERMINED. EVAL SUMMARY: THE DEVICE WAS RETURNED TO THE MFG FACILITY FOR EVAL. THE STENT REMAINS IMPLANTED AND WAS THEREFORE NOT AVAILABLE TO BE RETURNED WITH THE STENT DELIVERY SYSTEM. THE BALLOON HAD BEEN INFLATED. NO FURTHER DAMAGE NOTED. PROCEDURAL IMAGES WERE PROVIDED FOR REVIEW. REVIEW OF THE IMAGES CONFIRMED A CTO LESION IN THE LCX. THE CD CONTAINS IMAGES OF THE DISLODGED STENT LOCATED IMMEDIATELY DISTAL TO THE GUIDE CATHETER TIP IN THE LM WHERE IT WAS SUBSEQUENTLY DEPLOYED. FROM THE IMAGES IT APPEARS THAT THE PHYSICIAN ENCOUNTERED DIFFICULTIES ADVANCING THE DEVICE TO THE TARGET LESION. PLEASE NOTE THAT THIS DEVICE (B)(4) IS DISTRIBUTED OUTSIDE THE U.S.; HOWEVER, IT IS SIMILAR TO THE U.S. DISTRIBUTED PRODUCT - (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN INTENDED TO IMPLANT A 2.75 MM DIAMETER X 14 MM LENGTH RESOLUTE INTEGRITY RAPID EXCHANGE (RX) DRUG-ELUTING STENT TO TREAT A STENOSIS IN THE CX. WHILE THE DEVICE WAS BEING ADVANCED TO THE TARGET LESION, THE PHYSICIAN NOTED THAT THE STENT HAD DISLODGED FROM THE STENT DELIVERY SYSTEM, INTO THE LEFT MAIN VESSEL. THE PHYSICIAN REMOVED THE STENT DELIVERY SYSTEM AND ATTEMPTED TO RETRIEVE THE DISLODGED STENT USING A NEW BALLOON. THE DISLODGED STENT WAS SUCCESSFULLY DEPLOYED IN THE VESSEL. PT STATUS POST PROCEDURE WAS REPORTED TO BE GOOD AND NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTE INTEGRITY RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0005706224

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention