BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4657734 · Received April 3, 2015

    Report

    Report Number
    2024168-2015-01787
    Event Type
    Injury
    Date Received
    April 3, 2015
    Date of Event
    May 27, 2014
    Report Date
    March 10, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE VESSEL. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. THE REPORTED PATIENT EFFECTS OF MYOCARDIAL INFARCTION AND THROMBOSIS ARE KNOWN OBSERVED AND POTENTIAL PATIENT EFFECTS AS LISTED IN THE XIENCE PRIME LONG LENGTH (LL) EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    MAUDE REPORT RECEIVED THAT STATES: ON (B6) 2012 PATIENT ADMITTED WITH USA [ULTRASOUND ANGIOGRAPHY] AND FILMS REVEAL A 90% STENOSIS IN THE DISTAL RCA [RIGHT CORONARY ARTERY]. 3.0 X 33 XIENCE PRIME LL DEPLOYED WITH GOOD RESULTS AND PATIENT DISCHARGED AT THE TIME ON BRILINTA. CHANGED TO PLAVIX AT OFFICE VISIT LATER ON. (B6) 2013 PATIENT IS TAKEN OFF ASA [ASPIRIN] AND PLAVIX IN PREPARATION FOR COLONOSCOPY ON (B6) 2013 AND CHOLECYSTECTOMY ON (B6) 2013. A NOTE THAT TIME BY DIAGNOSTIC CARDIOLOGIST STATES THAT IT HAS BEEN GREATER THAN 1 YEAR SINCE PATIENT'S DRUG ELUTING STENT PLACEMENT, AND PATIENT WILL BE OFF PLAVIX FOR GI PROCEDURES. ON (B6) 2014 PATIENT ADMITTED WITH STEMI AND (B6) STATES THAT PATIENT HAS BEEN OFF PLAVIX SINCE GI PROCEDURES (B6) 2013. TAKEN EMERGENTLY TO CATH LAB AND FILMS REVEAL 100% THROMBOTIC OCCLUSION OF PROXIMAL EDGE OF PREVIOUSLY PLACED STENT IN DISTAL RCA. DILATATED WITH 2.3 X 15 TREK RX AND 3.5 X 23 XIENCE XPEDITION RX DEPLOYED OVERLAPPING EDGE OF PREVIOUSLY PLACED STENT WITH GOOD RESULTS. PATIENT DISCHARGED WITH PHYSICIAN DOCUMENTING THAT PATIENT WILL NEED TO BE ON LIFELONG PLAVIX. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221073 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2052241

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S