BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTEGRITY RX CORONARY STENT SYSTEM

    MDR report key: 2023193 · Received March 16, 2011

    Report

    Report Number
    9612164-2011-00068
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 18, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: (ROOT CAUSE OF EVENT CANNOT BE IDENTIFIED BASED ON INFO AVAILABLE), (PERFORATION, DEATH). CONCLUSION: NO CONCLUSION CAN BE DRAWN (ROOT CAUSE OF EVENT CANNOT BE IDENTIFIED BASED ON INFO AVAILABLE).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTEGRITY RAPID EXCHANGE (RX) CORONARY STENT WAS DEPLOYED TO THE LEFT CIRCUMFLEX ARTERY OF A PT. A PERFORATION OCCURRED WHICH WAS TREATED WITH ANOTHER MFR COVERED STENT. HOWEVER, IT WAS REPORTED THAT THE PT DIED APPROX TWO HRS POST PROCEDURE. ACCORDING TO THE PHYSICIAN, THE PT DEATH WAS PROBABLY NOT RELATED TO THE INTEGRITY STENT. THE CAUSE OF DEATH IS UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death