BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1932492 · Received December 18, 2010

    Report

    Report Number
    2024168-2010-02821
    Event Type
    Injury
    Date Received
    December 18, 2010
    Date of Event
    May 13, 2009
    Report Date
    November 22, 2010
    Manufacturer
    AV-CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT EQUIPMENT: STENTS:(2) 3.5 X 30 MM DRIVER; (2) 3.5 X 24 MM UNSPECIFIED BARE METAL STENTS; LIBERTE 4.0 X 20 MM; BALLOON CATHETER: BOSTON SCIENTIFIC THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION (MI), OCCLUSION, AND ANGINA AS LISTED IN THE PRODUCT INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WITH 99% STENOSIS. PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON, WHICH RESULTED IN A GRADE C DISSECTION. THE STUDY STENT WAS THEN PLACED, FOLLOWED BY ULTRASOUND WHICH REVEALED A DISSECTION AND HEMATOMA BETWEEN THE MEDIA AND ADVENTITIA, THEREFORE THE DISSECTION WAS TREATED WITH A CUTTING BALLOON AND THE PLACEMENT OF SEVERAL NON-ABBOTT STENTS. SEVERAL HOURS POST PROCEDURE, CHEST PAIN OCCURRED AND ST ELEVATION WAS NOTED. URGENT ANGIOGRAM WAS PERFORMED BECAUSE ACUTE MYOCARDIAL INFARCTION WAS SUSPECTED. A TOTAL OCCLUSION IN WAS NOTED IN THE DISTAL RCA. THE OCCLUSION WAS TREATED WITH CUTTING BALLOON AND A NON-ABBOTT STENT. SUBJECT WAS DISCHARGED (B)(6) 2009 ON ASPIRIN AND CLOPIDOGREL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-CLONMEL 8092941

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R| S CONCOMITANT EQUIPMENT