BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 2872032 · Received December 13, 2012

    Report

    Report Number
    9612164-2012-01772
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 11, 2012
    Report Date
    November 13, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: PATIENT CONDITION AFFECTED EFFECTIVENESS OF THE DEVICE (PATIENT LESION MORPHOLOGY PATIENT VESSEL MORPHOLOGY IMPACTED ON COMPLETE STENT EXPANSION). NO RESULTS AVAILABLE AS NO EVALUATION PERFORMED (NO DEVICE RETURNED FOR EVALUATION) EVALUATION CODES: CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION DEVICE (PATIENT LESION MORPHOLOGY, PATIENT VESSEL MORPHOLOGY IMPACTED ON COMPLETE STENT EXPANSION). (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN IMPLANTED A 2.5MM DIAMETER X 30MM LENGTH AND A 2.25MM DIAMETER X 30MM RESOLUTE INTEGRITY DRUG ELUTING STENTS IN A COMPLETE TOTAL OCCLUSION (CTO) OF THE LAD. THE STENTS WERE DEPLOYED OVERLAPPING. DURING THE PROCEDURE BOTH STENTS EXPERIENCED ISSUES WITH THE BALLOONS GETTING STUCK INSIDE THE STENTS AFTER PLACEMENT. THE BALLOONS WERE REMOVED, HOWEVER IT WAS REPORTED THAT THIS EVENT PROLONGED THE PROCEDURE. NO PATIENT INJURY OCCURRED AND NO CLINICAL SEQUELAE WERE REPORTED. CINE IMAGE REVIEW: THE TWO STENTS WERE DEPLOYED IN THE DISTAL AND MID TO DISTAL LAD. CINE IMAGES CONFIRM THESE STENTS WERE OVERLAPPING WITH EACH OTHER. THE VESSEL DISEASE APPEARS TO HAVE PREVENTED FULL CONCENTRIC STENT DEPLOYMENT. NO IMAGES WERE PROVIDED SHOWING THE MULTIPLE INFLATIONS OF THE STENT BALLOON DURING ATTEMPTS TO ENSURE THAT THE BALLOON WAS FULLY DEFLATED. NO IMAGES WERE SHOWN OF THE DELIVERY SYSTEM WITHDRAWAL AFTER THE STENT DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006155104

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR