BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1000139 · Received February 19, 2008

    Report

    Report Number
    2134265-2008-00479
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    November 13, 2006
    Report Date
    January 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    PMA / PMN Number
    P020009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    CLINICAL STUDY: IT WAS REPORTED THAT 403 DAYS AFTER A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT REQUIRED A TARGET VESSEL REINTERVENTION (TVR). THE PATIENT PRESENTED FOR TREATMENT WITH AN ACUTE MYOCARDIAL INFARCTION (MI). THE LESION BEING TREATED WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (MID LAD). TREATMENT INCLUDED THE ADMINISTRATION OF HEPARIN AND REPRO. THERE WAS A LARGE AREA OF THROMBUS, SO A THROMBECTOMY WAS PERFORMED. THE PATIENT HAD AN EPISODE OF BRADYCARDIA AND BECAME UNRESPONSIVE WITH ASSOCIATED HYPOTENSION. ASSISTED VENTILATION WAS INITIATED AND NIPRIDE WAS GIVEN. THE PATIENT DEVELOPED HEART FAILURE WHICH WAS TREATED WITH APPROPRIATE MEDICATIONS. THE PHYSICIAN SUCCESSFULLY PLACED A 3.5X20MM EXPRESS STUDY STENT. INTRAVASCULAR ULTRASOUND GUIDANCE WAS USED WITH EXCELLENT RESULTS. AT THIS POINT INTERVENTIONAL PROCEDURE WAS COMPLETED AND INTRA-AORTIC BALLOON PUMP WAS PLACED BECAUSE OF THE PATIENT'S PULMONARY EDEMA. THE PATIENT'S STATUS IMPROVED AND SHE WAS DISCHARGED 14 DAYS LATER AFTER BEING STARTED ON HEPARIN AND COUMADIN IN STABLE CONDITION. THE RELATIONSHIP OF THE DEVICE TO THE TVR IS UNKNOWN. FOUR HUNDRED AND THREE DAYS AFTER THE INDEX PROCEDURE, THE PATIENT RETURNED FOR ROUTINE HEART CATH COMPLAINT OF SHORTNESS OF BREATH WITH EXERTION. THE LAD STENT WAS PATENT WITH A MILD NEAR INTIMAL HYPERPLASIA UP TO 40% IN-STENT RESTENOSIS. THE SECOND DIAGONAL BRANCH HAD AN 80% OSTIAL STENOSIS. SUCCESSFUL BALLOON ANGIOPLASTY WAS PERFORMED IN THIS AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC 3.50X20MM 5678996

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R