BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BX SONIC STENT DELIVERY SYSTEM (OUS RX)

    MDR report key: 1083545 · Received July 28, 2008

    Report

    Report Number
    9616099-2008-01865
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    June 10, 2007
    Report Date
    June 30, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MAF
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ARTICLE ENTITLED: "SUCCESSFUL TRAPPING OF AN ORGANIZED THROMBUS IN A CORONARY ARTERY ANEURYSM IN MYOCARDIAL INFARCTION: CASE REPORT AND LITERATURE REVIEW". PUBLISHED IN CARDIOVASCULAR REVASCULARIZATION MEDICINE 9 (2008) PP. 52-55. THE PRODUCT IS NOT AVAILABLE FOR EVAL AND TESTING. THIS FEMALE EXPERIENCED RESTENOSIS OF A BX SONIC STENT. MEDICAL HISTORY LISTED ONLY A RISK FACTOR OF SMOKING. THE STENT WAS IMPLANTED TO TREAT A PRE-EXISTING THROMBOTIC CORONARY ANEURYSM IN THE PT'S PROXIMAL RCA. THE TREATMENT WAS SUCCESSFUL; HOWEVER, SHE WAS READMITTED APPROX. 6 MONTHS LATER WITH ANGINA; ANGIOGRAPHY IDENTIFIED THE RESTENOSIS. TREATMENT INCLUDED DRUG-ELUTING STENT IMPLANTATION. THE PRODUCT WAS NOT RETURNED FOR EVAL; IT REMAINED IMPLANTED. A REVIEW OF THE MFG RECORDS COULD NOT BE DONE WITHOUT A LOT NUMBER. RESTENOSIS IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING. PT'S WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. REVIEW OF THE AVAILABLE INFO SUGGESTS THAT VESSEL CHARACTERISTICS (PRE-EXISTING ANEURISMAL SEGMENT) MAY HAVE CONTRIBUTED TO THIS EVENT. PLEASE NOTE THAT THIS IS THE INITIAL/FINAL REPORT FOR THIS PRODUCT.

    Description of Event or Problem · 1

    AN ARTICLE FOUND DURING A LITERATURE SEARCH ENTITLED "SUCCESSFUL TRAPPING OF AN ORGANIZED THROMBUS IN A CORONARY ARTERY ANEURYSM IN MYOCARDIAL INFARCTION: CASE REPORT AND LITERATURE REVIEW" WAS FOUND. THE REPORT INDICATED THAT APPROX. SIX MONTHS AFTER IMPLANTATION OF A 4.0X 33MM BX SONIC STENT, THE PT EXPERIENCED STABLE ANGINA. THE STENT WAS IMPLANTED TO TREAT A PRE-EXISTING CORONARY ANEURYSM IN THE PROXIMAL RIGHT CORONARY ARTERY. CORONARY ANGIOGRAPHY WAS DONE AND AN IN-STENT RESTENOSIS WAS OBSERVED WITH NO EVIDENCE OF THE ANEURYSM REPORTED. THE RESTENOSIS WAS TREATED BY IMPLANTATION OF TWO ADD'L CYPHER STENTS WITH EXCELLENT RESULTS AFTER SIX MONTHS. THE PT WAS ASYMPTOMATIC WITH PRESERVED NORMAL LEFT VENTRICULAR FUNCTION WITH ONLY MILD INFERIOR HYPOKINESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BX SONIC STENT DELIVERY SYSTEM (OUS RX) CORONARY SDS/STENTS (MAF) MAF CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| L| R