BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1730426 · Received June 18, 2010

    Report

    Report Number
    2024168-2010-01219
    Event Type
    Injury
    Date Received
    June 18, 2010
    Date of Event
    May 25, 2010
    Report Date
    May 26, 2010
    Manufacturer
    ABBOTT VASCULAR CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). THE STENT REMAINS IN THE PT. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADD'L RELEVANT INFO. THE OTHER PROMUS (1009539-28B, 9121641) IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: THROMBOSIS/MYOCARDIAL INFARCTION. TIME OF ADVERSE EVENT: 5 DAYS POST PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2010, A 2.5X28 RX PROMUS STENT WAS DEPLOYED IN THE MID LEFT DESCENDING ARTERY (LAD) AND A 2.75X12 RX PROMUS STENT WAS DEPLOYED IN THE PRE-DILATED PROXIMAL LAD. THE TARGET LESION WAS MILDLY TORTUOUS, MILDLY CALCIFIED AND THROMBOTIC IN THE PROXIMAL TO MID LAD AND 100% STENOSED. POST DEPLOYMENT OF THE STENTS, ANGIOGRAM AND INTRAVASCULAR ULTRASOUND CONFIRMED NO ISSUES. ON (B)(6) 2010, THE PT EXPERIENCED CHEST PAIN. IT WAS FOUND THAT THE LESION FROM THE PROXIMAL EDGE OF THE LAD TO THE DISTAL PART OF THE LAD WAS COMPLETELY OCCLUDED. THROMBOSIS WAS ASPIRATED USING A THROMBUSTER. BALLOON DILATATION WAS PERFORMED USING A NON-ABBOTT BALLOON CATHETER IN THE PROXIMAL LAD. THE PT WAS PLACED ON AN INTRA AORTIC BALLOON PUMP (IABP); HOWEVER, BLOOD FLOW DID NOT IMPROVE. THEREFORE, ADD'L DILATATION WAS PERFORMED USING A NON-ABBOTT BALLOON CATHETER. THE IABP WAS REMOVED FROM THE PT ON (B)(6) 2010. PRIMARY DIAGNOSIS WAS MYOCARDIAL INFARCTION. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR CLONMEL NA 9092241

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R STENT: PROMUS (1009539-28B, 9121641)| GUIDE WIRE: RUNTHROUGH| GUIDE CATH: BRITETIP| DIL CATH: HIRYU 2.25 X 15| 2.5 X 15| HEPARIN