BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM

    MDR report key: 1840814 · Received September 17, 2010

    Report

    Report Number
    2024168-2010-01953
    Event Type
    Death
    Date Received
    September 17, 2010
    Date of Event
    March 6, 2008
    Report Date
    August 31, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    P970020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT DEATH IS A KNOWN ADVERSE EVENT LISTED IN THE ULTRA INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS 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. EG: PP JOKHI, K RAMANATHAN, S WALSH, ET AL. "EXPERIENCE OF STENTING FOR ATHEROSCLEROTIC RENAL ARTERY STENOSIS IN A CARDIAC CATHETERIZATION LABORATORY: TECHNICAL CONSIDERATIONS AND COMPLICATIONS." CAN J CARDIOL, VOL 25, NO 8, AUGUST 2009. THE UNK RX TETRA, UNK HERKULINK, INDICATED ARE BEING FILED UNDER SEPARATE MFR#'S.

    Description of Event or Problem · 1

    THE FOLLOWING EVENTS WERE NOTED DURING LITERATURE REVIEW: A PROSPECTIVE STUDY WAS PERFORMED IN 106 PATIENTS IN REVIEW. ONE HUNDRED SIX PATIENTS UNDERWENT RENAL ARTERY STENTING. OF THOSE 106 PATIENTS AT APPROXIMATELY 6 WEEKS AND 10 MONTHS, TWO PATIENTS DIED REPORTED TO BE FROM RENAL FAILURE AND CARDIAC CAUSES. OF THOSE 106 PATIENTS, 6 PATIENTS SUFFERED FROM RENAL DEFICIENCY AND HIGH CREATINE LEVELS, 1 PATIENT SUFFERED A DISSECTION, AND 2 PATIENTS UNDERWENT REVASCULARIZATION FOR PLANNED CABG PROCEDURES. ONE PATIENT UNDERWENT REVASCULARIZATION OF THE RENAL ARTERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death GUIDE WIRE: FILTERWIRE EZ| LIBERTE| STENT: EXPRESS| ANGIOGUARD| UNK RX TETRA| GENESIS| RACER| UNK HERKULINK