BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3210399 · Received July 8, 2013

    Report

    Report Number
    2024168-2013-04257
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 14, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIRST UNKNOWN RX XIENCE PRIME STENT MENTIONED IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ANGINA, THROMBOSIS, AND STENOSIS/RESTENOSIS ARE LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS KNOWN PATIENT EFFECTS OF 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, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PRESENTED WITH NON-ST-ELEVATED MYOCARDIAL INFARCTION, CORONARY HEART DISEASE OF THE CIRCUMFLEX AND LEFT ANTERIOR DESCENDING CORONARY ARTERIES, AND A RESTRICTED LEFT VENTRICLE FUNCTION OF 59% EJECTION FRACTION. CONSEQUENTLY, ON (B)(6) 2013, TWO UNSPECIFIED RX XIENCE PRIME STENTS HAD BEEN IMPLANTED IN THE DISTAL CIRCUMFLEX CORONARY ARTERY, WITH ONE STENT IN THE 1ST OBTUSE MARGINAL (OM1) CORONARY ARTERY AND THE 2ND STENT IN THE 2ND OBTUSE MARGINAL (OM2). ON (B)(6) 2013, THE PATIENT EXPERIENCED ANGINA THAT HAD BEEN CAUSING SLEEPLESSNESS. THE PATIENT ARRIVED AT THE HOSPITAL ON (B)(6) 2013 AND SUBACUTE OCCLUSION OF BOTH STENTS WAS DIAGNOSED. THE STENT OCCLUSION IN OM1 WAS TREATED VIA DEPLOYMENT OF A 2.25X12 RX XIENCE PRIME STENT AT 14 ATMOSPHERES (ATM) AND A 2.5X18 RX XIENCE PRIME STENT AT 20 ATM. THE OM2 STENT OCCLUSION WAS TREATED VIA BALLOON ANGIOPLASTY USING A 3.0X12 NC TREK BALLOON DILATATION CATHETER. OVERALL INTERVENTION RESULTED IN A TIMI FLOW 3. REPORTEDLY, THOUGH THE PATIENT EXPRESSED TO THE PHYSICIAN THAT PRESCRIBED MEDICATIONS HAVE BEEN TAKEN ACCURATELY, THE PHYSICIAN INDICATED THAT THE PATIENT LIKELY DID NOT OBSERVE THE RECOMMENDATIONS OF DUAL ANTIPLATELET THERAPY (DAPT) WITH PRASUGREL AFTER STENT PLACEMENT ON (B)(6) 2013. THE PHYSICIAN INDICATED THAT MOST PROBABLE CAUSE OF THE OCCLUSIONS DUE TO A COMBINATION OF A STENT RESTENOSIS AND A THROMBOSIS THAT HAD DEVELOPED FOR A LONGER TIME DUE TO THE PATIENT NOT BEING COMPLIANT WITH DAPT MEDICATION. THE PATIENT WAS DISCHARGED WITH SATISFACTORY RESULTS AND IN GOOD CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311151 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R