BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 772041 · Received October 19, 2006

    Report

    Report Number
    6000089-2006-02278
    Event Type
    Injury
    Date Received
    October 19, 2006
    Date of Event
    September 21, 2006
    Report Date
    September 25, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE; AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. SHOULD FURTHER RELEVANT INFO BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CLINICAL STUDY # 202244. IT WAS REPORTED THAT 1623 DAYS AFTER A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE PT HAD A MYOCARDIAL INFARCTION (MI) AND REQUIRED A TARGET VESSEL REINTERVENTION (TVR). THE INDEX PROCEDURE TREATED A 3.5X12MM, 80% STENOSED LESION IN THE MID RIGHT CORONARY ARTERY (MID RCA) WITH PREDILATION AND PLACEMENT OF AN EXPRESS2 3.5X16MM BARE METAL STENT WITH 0% RESIDUAL STENOSIS. AT 1623 DAYS, AFTER THE INDEX PROCEDURE, THE PT PRESENTED TO AN OUTLYING HOSP WITH SEVERE, WORSENING CHEST PAIN. EKG SHOWED AN INFERIOR MI AND THE PT WAS TRANSFERRED TO THE STUDY HOSP FOR ENERGENT CORONARY ANGIOGRAPHY. CORONARY ANGIOGRAPHY REVEALED 99% IN-STENT RESTENOSIS IN THE MID RCA. AFTER PREDILATION, TWO TAXUS 3.5X24MM AND 3.5X12MM STENTS WERE PLACED IN THE TARGET LESION AND THEN POST-DILATED WITH RESIDUAL STENOSIS OF 0%. THE PT WAS DISCHARGED 2 DAYS LATER. THE PHYSICIAN NOTED, IT WAS POSSIBLE THE SERIOUS ADVERSE EVENT WAS RELATED TO THE DEVICE. NO FURTHER INFO ABOUT EVENT IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM CORONARY STENT SYSTEM MAF BOSTON SCIENTIFIC 3.50 X 16MM 4426271

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| O| R