BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ STENT UNKNOWN

    MDR report key: 1080762 · Received July 22, 2008

    Report

    Report Number
    9610978-2008-00188
    Event Type
    Injury
    Date Received
    July 22, 2008
    Report Date
    June 24, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT, IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED DRUG-ELUTING STENTS. THE STERILE LOT NUMBER FOR THE DEVICE IS UNKNOWN THEREFORE, A DEVICE HISTORY REPORT REVIEW COULD NOT BE CONDUCTED. STENT INFECTION IS A RARE COMPLICATION OF CORONARY ANGIOPLASTY. PSEUDOMONAS AERUGINOSA IS ONE OF THE MORE PREVALENT BACTERIUMS ASSOCIATED WITH HOSPITAL ACQUIRED INFECTIONS. THE MOST COMMON SITES FOR PSEUDOMONAS ARE THE LOWER RESPIRATORY TRACT, SURGICAL WOUNDS, URINARY TRACT AND THE BLOODSTREAM. INFECTIONS FROM PSEUDOMONAS IN THE BLOODSTREAM AND RESPIRATORY TRACT WERE ASSOCIATED WITH CERTAIN AREAS IN AN INTENSIVE CARE UNIT. THERE ARE MANY FACTORS THAT CAN IMPACT THE INTEGRITY OF THE STERILE FIELD NECESSARY TO PREVENT INFECTIONS DURING AN INVASIVE PROCEDURE. THERE ARE ALSO PROCEDURES THAT OCCUR PRIOR TO ADMITTANCE INTO A CATH LAB THAT CAN CAUSE INFECTION SUCH AS DRAWING BLOOD AND STARTING AN INTRAVENOUS LINE. ANY TIME THAT THE PROTECTIVE BARRIER OF SKIN IS COMPROMISED OR BREACHED, THERE IS A POTENTIAL FOR INFECTION. WITH THE LIMITED AMOUNT OF AVAILABLE INFO, IT IS NOT POSSIBLE TO DETERMINE EXACTLY WHAT FACTORS MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    AS IT WAS REPORTED IN A LITERATURE REVIEW: A MALE HAD A PALMAZ-SCHATZ STENT IMPLANTED IN THE LEFT CIRCUMFLEX ARTERY. THE PT HAD A CORONARY STENT INFECTION DUE TO PSEUDOMONAS AERUGINOSA, SHORTLY AFTER IMPLANTATION OF THE STENT (4 DAYS), WHICH PRESENTED AS AN ACUTE PERICARDITIS. ANGIOGRAPHY DETERMINED A PSEUDOANEURYSM IN THE LEFT CIRCUMFLEX AS WELL. SURGICAL TREATMENT CONSISTED OF STENT REMOVA,L AND PARTIAL EXCISION OF THE CIRCUMFLEX ARTERY WITHOUT CORONARY ARTERY BYPASS GRAFTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ STENT UNKNOWN NONE MAF CORDIS EUROPA, N.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention