BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRITY RX CORONARY STENT SYSTEM

    MDR report key: 2093109 · Received April 14, 2011

    Report

    Report Number
    9612164-2011-00239
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 17, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL, RESULTS, CONCLUSION: (PT VESSEL MORPHOLOGY). (USE OF FORCE). EVAL SUMMARY: STENT WAS MOVED DISTALLY ON THE BALLOON. THE FIRST AND SECOND PROXIMAL STENT SEGMENTS WERE RAISED, DAMAGED AND OVERLAPPING DISTALLY. THE DISTAL TIP WAS SLIGHTLY DAMAGED. THE BALLOON HAD NOT BEEN INFLATED. NO FURTHER DAMAGES WERE NOTED.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO DEPLOY A 2.25 MM DIAMETER X 08MM LENGTH INTEGRITY RAPID EXCHANGE (RX) BARE METAL STENT IN A MILDLY CALCIFIED LESION WITH 70% STENOSIS LOCATED IN THE OSTIAL 2ND DIAGONAL. THE LESION WAS PRE-DILATED WITH 40% STENOSIS REMAINING. IT WAS REPORTED THAT FORCE WAS USED TO TRY AND CROSS THE LESION, AND WHEN THE DEVICE WAS REMOVED FROM THE PT, THE STENT WAS NOTED TO BE DAMAGED. THE DEVICE WAS INSPECTED AND PREPPED WITH NO ABNORMALITIES NOTED. NO PT INJURY OCCURRED AND NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRITY RX CORONARY STENT SYSTEM MAF MEDTRONIC IRELAND NA 0002014744

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK