BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1805030 · Received August 13, 2010

    Report

    Report Number
    2024168-2010-01670
    Event Type
    Injury
    Date Received
    August 13, 2010
    Date of Event
    May 8, 2010
    Report Date
    July 21, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ADDITIONAL TWO PROMUS 2.5 X 28 MM (PART#1009539-28B/LOT#0012842, TWO PROMUS 2.75 X 28 MM (PART# 1009540-28B/LOT#9121541), AND ONE PROMUS 3.0 X 18 MM (PART# 1009541-18B/LOT#9120941) MENTIONED ARE BEING FILED UNDER SEPARATE MANUFACTURER NUMBERS. EVALUATION SUMMARY: IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA, MYOCARDIAL INFARCTION, NAUSEA, AND THROMBOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE (IFU). 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. ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO A 100% VISUAL INSPECTION. IN ADDITION, A QUALITY CONTROL (Q.C.) AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    ADVERSE EVENT: THROMBOSIS WITH MEDICAL INTERVENTION/MYOCARDIAL INFARCTION (MI). ONSET OF ADVERSE EVENT: 4 DAYS POST PROCEDURE. DEVICE ISSUE: NONE. IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2010, DUE TO STABLE ANGINA AND AS PART OF A STAGED PROCEDURE, THE PATIENT UNDERWENT THE STUDY INDEX PROCEDURE WITH DEPLOYMENT OF SIX DRUG ELUTING STENTS: ONE IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA), TWO IN THE MID RCA, ONE IN THE DISTAL RCA AND TWO IN THE FIRST RIGHT POSTERIOR LATERAL. POST STENT DEPLOYMENT, RESIDUAL STENOSIS WAS 0% IN ALL SITES. THE PATIENT DID NOT RECEIVE A PERI-PROCEDURAL LOADING DOSE OF CLOPIDOGREL. THE PATIENT WAS DISCHARGED SAME DAY. ON (B)(6) 2010, THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM DUE TO SEVERE CHEST PAIN, NAUSEA, AND SWEATING. ELECTROCARDIOGRAM (ECG) SHOWED ST ELEVATION INFERIOR LEADS, SUGGESTIVE FOR AN ACUTE MI. CARDIAC CATHETERIZATION SHOWED RCA OCCLUDED 100% WITH EVIDENCE OF THROMBUS. THROMBECTOMY WAS PERFORMED WITH EXCELLENT RESULTS AND NO COMPLICATIONS. THE EVENT WAS CONSIDERED RESOLVED ON (B)(6) 2010 AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR CLONMEL NA 0012842

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R| S TWO PROMUS 2.5 X 28 MM (PART#1009539-28B/| PROMUS 3.0 X 18 MM (PART# 1009541-18B/LOT#9120941)| TWO PROMUS 2.75 X 28 MM (PART# 1009540-28B/| LOT#0012842)| LOT#9121541)