BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTI-LINK RX PIXEL CORONARY STENT SYSTEM

    MDR report key: 2032451 · Received March 29, 2011

    Report

    Report Number
    2024168-2011-02097
    Event Type
    Death
    Date Received
    March 29, 2011
    Date of Event
    December 24, 2009
    Report Date
    March 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P970020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. STENT: ENDEAVOR (2); PIXEL 2.25X13. THE PIXEL STENT WILL BE FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF DEATH, AS LISTED IN THE RX PIXEL INSTRUCTIONS FOR USE IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2009, THREE NON-ABBOTT STENTS WERE IMPLANTED IN THE RIGHT CORONARY ARTERY. POST DILATATION WAS PERFORMED AND BLOOD FLOW WAS TIMI 3. ON (B)(6) 2009, THE PATIENT EXPERIENCED CHEST PAIN. ON (B)(6) 2009, PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED. TWO NON-ABBOTT STENTS WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY, AND TWO PIXEL STENTS (2.25 X 13 AND 2.25 X 8) WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY. POST DILATATION WAS PERFORMED AND BLOOD FLOW WAS TIMI 3. ON (B)(6) 2009, THE PATIENT WAS TAKEN TO A DIFFERENT HOSPITAL AND DIED. THE CAUSE OF DEATH IS UNKNOWN. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX PIXEL CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death