BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY RX CORONARY STENT SYSTEM

    MDR report key: 2092788 · Received May 10, 2011

    Report

    Report Number
    9612164-2011-00405
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    March 28, 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: VESSEL HIGHLY CALCIFIED. MULTIPLE PRE-DILATIONS AND POSITIONING DIFFICULTIES. DISSECTION AND STENT THROMBOSIS. EVALUATION CODES: CONCLUSION: VESSEL HIGHLY CALCIFIED. MULTIPLE PRE-DILATIONS AND POSITIONING DIFFICULTIES.

    Description of Event or Problem · 1

    A 3.5MM DIAMETER X 15MM LENGTH INTEGRITY RAPID EXCHANGE (RX) STENT WAS DEPLOYED TO THE DISTAL RIGHT CORONARY ARTERY. THE RCA WAS REPORTED TO BE HIGHLY CALCIFIED AND REQUIRED MULTIPLE PRE-DILATIONS AND NUMEROUS ATTEMPTS TO POSITION THE STENT ACROSS THE LESION PRIOR TO THE SUCCESSFUL DEPLOYMENT. IVUS CONFIRMED THAT THE STENT WAS APPOSED TO THE VESSEL WALL. APPROXIMATELY FIFTEEN MINUTES POST PROCEDURE, THE PATIENT DEVELOPED CHEST AND PAIN AND EKG CHANGES. AN ANGIOGRAM CONFIRMED AN ACUTE STENT THROMBOSIS. THE ANGIOGRAM ALSO SHOWED A POSSIBLE DISSECTION IMMEDIATELY PROXIMAL TO THE NEWLY DEPLOYED STENT. A THROMBECTOMY CATHETER WAS INSERTED INTO THE PATIENT AND THE THROMBUS WAS RESOLVED. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO OTHER 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 0005141754

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ANGIOMAX