BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM

    MDR report key: 1023394 · Received April 2, 2008

    Report

    Report Number
    2134265-2008-00957
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    November 2, 2007
    Report Date
    March 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MAF
    PMA / PMN Number
    P020009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL: 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    CLINICAL TRIAL. IT WAS REPORTED THAT POST INDEX PROCEDURE, THE PT HAD A TARGET VESSEL REVASCULARIZATION (TVR). THE PT PRESENTED TO THE INDEX WITH AN ACUTE MYOCARDIAL INFARCTION. THE INDEX PROCEDURE TREATED A DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS 2.5 MM WIDE, 24 MM LONG, AND 80% STENOSED. THE PHYSICIAN PREDILATED THE LESION PRIOR TO PLACING A 2.5 X 24 MM EXPRESS2 STENT. RESIDUAL STENOSIS WAS 0%. THE PT RECEIVED FENTANYL, VERSED, INTEGRILIN, HEPARIN, NITROGLYCERIN, AND NIPRIDE DURING THE PROCEDURE. THE PT WAS DISCHARGED 3 DAYS LATER ON ASPIRIN AND PLAVIX (AMONGST OTHERS). ABOUT 391 DAYS LATER, THE PT WAS ADMITTED FOR THE SCHEDULED 13 MONTH FOLLOW UP. THE PT DESCRIBED ANGINA AND FATIGUE AT THIS TIME. THE MID LAD CONTAINED A LONG AREA OF 75% IN-STENT RESTENOSIS. THE PT WAS SUCCESSFULLY TREATED WITH IVUS GUIDED STENTING OF THE LAD. A DE NOVO LESION IN THE LCX WAS ALSO TREATED WITH IVUS GUIDED BALLOON ANGIOPLASTY. THE LAD STENOSIS WAS TREATED WITH OVERLAPPING TAXUS STENTS: A 2.5 X 16 MM, AS WELL AS A 2.5 X 20 MM. THE EVENT WAS CONSIDERED RESOLVED. IN THE OPINION OF THE PHYSICIAN, THERE IS A POSSIBLE RELATIONSHIP BETWEEN THE TVR AND THE EXPRESS2 STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS2 MONORAIL CORONARY STENT DELIVERY SYSTEM MAF STENT, CORONARY MAF BOSTON SCIENTIFIC CORPORATION 2.5 X 24 MM 6131124

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R