BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3850683 · Received June 5, 2014

    Report

    Report Number
    9612164-2014-00563
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    April 7, 2014
    Report Date
    May 9, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: FAILURE TO FOLLOW INSTRUCTIONS (FORCE WAS USED DURING THE PROCEDURE). DEFORMATION PROBLEM; RELATED TO OPERATIONAL CONTEXT (DETACHMENT OF THE HYPOTUBE IS MOST LIKELY PROCEDURAL RELATED). EVALUATION CONCLUSION: FAILURE TO FOLLOW INSTRUCTIONS (FORCE WAS USED DURING THE PROCEDURE). OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (DETACHMENT OF THE HYPOTUBE IS MOST LIKELY PROCEDURAL RELATED). (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO DEPLOY A RESOLUTE INTEGRITY 2.25MM DIAMETER X 30MM LENGTH RX DRUG ELUTING STENT. THE TARGET LESION WAS IN THE LCX. IT WAS REPORTED THAT A FORCE GREATER THAN EXPECTED WAS REQUIRED TO ADVANCE THE DEVICE. DURING THE ADVANCEMENT, THE SHAFT OF THE DEVICE AT THE Y PIECE, WAS BROKEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED. DEVICE EVALUATION: THE STENT WAS POSITIONED BETWEEN THE MARKER BANDS AS PER SPECIFICATIONS. SLIGHT PINCHING OF THE DISTAL STENT SEGMENTS WAS NOTED. THE HYPOTUBE HAD DETACHED 17.7CM DISTAL TO THE STRAIN RELIEF. THE BREAK SITES WERE OVAL AND JAGGED. THE HYPOTUBE WAS KINKED PROXIMAL AND DISTAL TO THE DETACHMENT SITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329809 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006980800

    Patients

    Seq Age Sex Outcome Treatment
    1