BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX PIXEL CORONARY STENT SYSTEM

    MDR report key: 1002004 · Received February 22, 2008

    Report

    Report Number
    2024168-2008-00133
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    December 20, 2006
    Report Date
    January 24, 2008
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION. IT WAS REPORTED THAT THE PATIENT HAD THROMBUS PRIOR TO IMPLANTING THE PIXEL STENT. THE INSTRUCTIONS FOR USE CONTRAINDICATES THE USE OF THIS PRODUCT IN PATIENTS WHO EXHIBIT ANGIOGRAPHIC OR CLINICAL EVIDENCE OF EXISTING THROMBOSIS. IFU LISTS RESTENOSIS OF THE STENTED SEGMENT AS A KNOWN ADVERSE EFFECT OF CORONARY STENTING. THIS KNOWN PATIENT EFFECT IS NOT NECESSARILY AN INDICATION OF A PRODUCT ISSUE, AND NO DEVICE ISSUES/MALFUNCTION WERE REPORTED DURING THE PROCEDURE. A CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED, BUT THE REPORTED PATIENT EFFECT IS A KNOWN ADVERSE EVENT OF CORONARY STENTING.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY-MEDICAL INTERVENTION. REPORTING RATIONALE: IN-STENT RESTENOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NONE. PMS CASE. IT WAS REPORTED THAT THE INITIAL PROCEDURE WAS IN 2006, TO TREAT A PATIENT PRESENTED WITH ANGINA DECUBITUS. THE TARGET LESION WAS 90% STENOSED WITH CALCIFICATION. AFTER SUCTIONING OUT THE THROMBUS, THE LESION WAS PREDILATED AND THE 2.25 X 13 MM PIXEL STENT WAS DEPLOYED. ON APPROX THREE AND A HALF MONTHS LATER, FOLLOW-UP CORONARY ANGIOGRAPHY WAS PERFORMED AT WHICH TIME 90% IN-STENT RESTENOSIS WAS CONFIRMED. AFTER USING A ROTABLATOR, THE STENOSIS WAS PRE-DILATED AND ANOTHER COMPANY'S DEVICE WAS DEPLOYED TO COMPLETE THE PROCEDURE. IN 2007, THE PATIENT FOLLOW-UP SHOWED NO PROBLEMS. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX PIXEL CORONARY STENT SYSTEM 74MAF MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 6071831

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention OTHER: ROTABLATOR| DIL CATH: TIP TOP| GUIDE WIRE: ROTAWIRE| GUIDE CATH: MACH 1| STENT: CYPHER (TREATMENT)