BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY RX CORONARY STENT SYSTEM

    MDR report key: 2092758 · Received May 10, 2011

    Report

    Report Number
    9612164-2011-00399
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    March 25, 2011
    Report Date
    April 11, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS: NO CONCLUSION CAN BE DRAWN BASED ON INFORMATION PROVIDED TO DATE. STENT THROMBOSIS.

    Description of Event or Problem · 1

    FOUR INTEGRITY RX BARE METAL CORONARY STENTS WERE DEPLOYED TO A PATIENT'S RIGHT CORONARY ARTERY. THE VESSEL WAS REPORTED TO BE HIGHLY CALCIFIED WITH A LONG DISEASED SEGMENT WHICH REQUIRED MULTIPLE PRE-DILATATIONS PRIOR TO THE DEPLOYMENT OF THE STENTS. APPROXIMATELY TWENTY MINUTES POST DEPLOYMENT OF THE STENTS, AN ANGIOGRAM FOUND AN ACUTE THROMBOSIS WITHIN THE THIRD STENT IN THE MID RIGHT CORONARY ARTERY. INFORMATION RECEIVED CONFIRMED THAT THERE APPEARED TO BE AN UNSTENTED GAP BETWEEN THE THIRD AND FOURTH STENT WHERE THE THROMBOSIS OCCURRED. A THROMBECTOMY CATHETER WAS INSERTED INTO THE PATIENT TO RESOLVE THE THROMBUS. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO OTHER CLINICAL SEQUELAE WERE REPORTED. REFERENCE MFR REPORT NUMBERS 9612164201100396, 9612164201100397 AND 9612164201100398.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRITY RX CORONARY STENT SYSTEM MAF MEDTRONIC IRELAND NA 0005089558

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ANGIOMAX