BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3002765 · Received March 13, 2013

    Report

    Report Number
    2024168-2013-01447
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 20, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. IN THIS CASE, THERE WERE NO REPORTED PRODUCT DEFICIENCIES. ANGINA, ELECTROCARDIOGRAM (EKG/ECG) CHANGES AND THROMBOSIS ARE LISTED IN THE (B)(4) XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS. 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. THE 3.5 X 38 MM XIENCE PRIME DEVICE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET AREAS WERE LOCATED IN THE DISTAL TO PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH MODERATE TORTUOSITY AND 90% STENOSIS. ON (B)(6) 2012, A 3.0 X 23 MM XIENCE PRIME STENT WAS DEPLOYED IN THE DISTAL RCA AND A 3.5 X 38 MM XIENCE PRIME STENT WAS DEPLOYED IN THE PROXIMAL TO MID RCA. THE TWO STENTS WERE IMPLANTED OVERLAPPING. INTRA-VASCULAR ULTRASOUND (IVUS) WAS NOT PERFORMED IN THE PROCEDURE. ON (B)(6) 2013, A PROCEDURE WAS PERFORMED FOR A SHUNT VESSEL AND THE PATIENT WAS ALSO TO RECEIVE DIALYSIS. DURING THE DIALYSIS, THE ELECTROCARDIOGRAM (EKG) BECAME ABNORMAL AND THE PATIENT EXPERIENCED SLIGHT CHEST PAIN. ANGIOGRAPHY WAS PERFORMED AND THROMBOSIS WAS OBSERVED IN THE RCA. IT WAS ALSO NOTED UNDER IVUS THAT THE SHAPE OF THE 3.5 X 38 MM XIENCE PRIME STENT WAS PARTIALLY ELLIPSED. DILATATION WAS PERFORMED IN THE RCA AND TWO NON-ABBOTT STENTS WERE DEPLOYED INSIDE THE TWO XIENCE PRIME STENTS. POST-DILATATION AND IVUS WERE PERFORMED TO COMPLETE THE PROCEDURE. THE PHYSICIAN COMMENTED THAT THE ELLIPSE-SHAPED STENT MIGHT HAVE CAUSED THE THROMBOSIS OR THE ANTICOAGULANT DRUGS MIGHT HAVE NOT WORKED PROPERLY AND THAT HE DID NOT KNOW THE ROOT CAUSE. THE PHYSICIAN FEELS THAT THE PATIENT WILL NEED CORONARY ARTERY BYPASS GRAFTING (CABG) IN THE NEAR FUTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105420 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2061141

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STENT: 3.5 X 38 MM XIENCE PRIME