BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX PIXEL CORONARY STENT SYSTEM

    MDR report key: 1024933 · Received April 3, 2008

    Report

    Report Number
    2024168-2008-00265
    Event Type
    Injury
    Date Received
    April 3, 2008
    Date of Event
    August 17, 2006
    Report Date
    March 6, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS SUMMATION: PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO. THE PT EFFECT OF RESTENOSIS IS LISTED IN THE PIXEL IFU AS A KNOWN ADVERSE EFFECT OF CORONARY STENTING PROCEDURES. REPORTEDLY, THE PIXEL STENT IMPLANTS WERE USED TO TREAT A LESION IN AN ACUTE MYOCARDIAL INFARCTION CASE. THE DEVICE IFU STATES THAT IT IS A CONTRAINDICATION TO USE THE DEVICE IN: "PTS WHO HAVE EXPERIENCED A RECENT (LESS THAN 1 WEEK) ACUTE MYOCARDIAL INFARCTION." HOWEVER, IN THIS CASE, A CONCLUSIVE ROOT CAUSE FOR THE RESTENOSIS CANNOT BE DETERMINED. THE SECOND MULTI-LINK PIXEL, LOT# 5050931 IS INDICATED, IS BEING FILED UNDER THE SAME MFG REPORT NUMBER.

    Description of Event or Problem · 1

    REPORTING RATIONALE: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: RESTENOSIS REQUIRING ADD'L STENTING. DEVICE ISSUE: NONE. PMS CASE. IT WAS REPORTED THAT THE INITIAL PROCEDURE WAS TO TREAT AN AMI PT IN 2006. PRE-DILATATION WAS PERFORMED WITH ANOTHER COMPANY'S 2.5 X 15 MM BALLOON IN THE TARGET LESIONS WHICH HAD NO TORTUOSITY, CALCIFICATION AND 90% STENOSIS. THE 2.5 X 23 MM PIXEL STENT WAS IMPLANTED IN THE PROXIMAL LAD AND THE 2.5 X 18 MM PIXEL STENT WAS IMPLANTED IN THE MID LAD. BOTH STENTS WERE IMPLANTED SUCCESSFULLY. ON SIX AND A HALF MONTHS LATER, THE PT RETURNED FOR A FOLLOW-UP AND IN STENT RESTENOSIS (ISR) AS CONFIRMED. ON TWO WEEKS LATER, 2006, PCI WAS PERFORMED AND TWO STENTS, OF ANOTHER COMPANY, WERE IMPLANTED TO TREAT THE ISR. THE PT WAS REPORTED TO BE RECOVERED. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX PIXEL CORONARY STENT SYSTEM MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 5080931

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R RUNTHROUGH GUIDING CATHETER: MACH 1 JL 4.0| STENT: 2.5 X 23 MM PIXEL| GUIDE WIRE: ATHLETE GT SOFT| DILATATION CATHETER: 2.5 X 15 MM OTTIMO