BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3011603 · Received March 19, 2013

    Report

    Report Number
    2024168-2013-01587
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 25, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRE-DILATATION. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. ALTHOUGH A CONCLUSIVE CAUSE FOR THE PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE IF ANY CANNOT BE DETERMINED, ANGINA, ELECTROCARDIOGRAM (EKG/ECG) CHANGES, AND THROMBOSIS ARE LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS OF CORONARY STENTING PROCEDURES. IT SHOULD BE NOTED THAT THE XIENCE PRIME IFU INSTRUCTS THE PHYSICIAN TO PRE-DILATE THE LESION WITH A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, THE PATIENT PRESENTED WITH CHEST PAIN AND WAS DIAGNOSED WITH AN ACUTE MYOCARDIAL INFARCT (AMI). PLAVIX AND BAYER ASPIRIN WERE ADMINISTERED PRIOR TO PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. THE PCI WAS TO TREAT A 99% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH MILD TORTUOSITY AND MILD CALCIFICATION. THE 2.5 X 28 MM XIENCE PRIME STENT WAS IMPLANTED BY DIRECT-STENTING, AT 12 ATMOSPHERES, 2 INFLATIONS. TIMI FLOW 3 WAS ACHIEVED AND POST-DILATATION WAS NOT PERFORMED. THE PROCEDURE WAS COMPLETED WITHOUT PERFORMING POST-PROCEDURAL INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION AND THE PATIENT WAS TRANSFERRED TO A CORONARY CARE UNIT. THIRTY MINUTES LATER, THE PATIENT COMPLAINED OF CHEST PAIN AGAIN AND ST SEGMENT ELEVATION WAS OBSERVED. IN-STENT THROMBOSIS WAS CONFIRMED UNDER ANGIOGRAPHY. THE THROMBOSIS WAS ASPIRATED AND THEN IVUS WAS PERFORMED WHICH CONFIRMED THAT THE PROXIMAL PART OF THE DEPLOYED STENT IMPLANT WAS NOT FULLY EXPANDED. THUS, BALLOON ANGIOPLASTY WAS PERFORMED WITH A NON-COMPLIANT BALLOON CATHETER AND THE PROCEDURE WAS COMPLETED. THE PATIENT REMAINED HOSPITALIZED FOR OBSERVATION, BUT WAS RELEASED ON (B)(6) 2013. THE PHYSICIAN COMMENTED THAT THE THROMBUS FORMATION MAY HAVE OCCURRED DUE TO ANY OF THE FOLLOWING CAUSES: THE ANTI-PLATELETS MAY NOT HAVE BEEN TAKING EFFECT; THE HEPARIN DOSE DURING THE PROCEDURE MAY NOT HAVE BEEN SUFFICIENTLY ADMINISTERED; THE STENT IMPLANT MAY NOT HAVE BEEN FULLY EXPANDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114632 XIENCE PRIME SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2071641

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R GUIDE WIRE: RUNTHROUGHNSGUIDE CATH: 6F MACH