BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3863934 · Received June 10, 2014

    Report

    Report Number
    2024168-2014-03707
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 5, 2014
    Report Date
    April 15, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT ESTIMATED AS (B)(6) 2014, THE DATE OF ARTICLE PUBLICATION. EVENT DESCRIPTION CONTINUED: FOUR MONTHS LATER THE PATIENT PRESENTED WITH CHEST PAIN. ECG SHOWED ST DEPRESSIONS AND T-WAVE INVERSIONS IN V2-V6. TNT WAS 0.45 NG/ML. CARDIAC CATHETERIZATION SHOWED SIGNIFICANT ENLARGEMENT OF THE LAD ANEURYSM AND 90% IN-STENT RESTENOSIS PROXIMAL AND DISTAL TO THE ANEURYSM. SKIN TESTING SHOWED THE PATIENT HAD NO ALLERGY TO COBALT, CHROMIUM OR NICKEL. HYPERSENSITIVITY VASCULITIS AS A RARE COMPLICATION OF EVEROLIMUS ELUTING STENTS WAS CONSIDERED TO HAVE RESULTED IN THE ANEURYSM FORMATION. THERE WERE NO SYSTEMIC SIGNS OF VASCULITIS OR ARTERITIS. CONCOMITANT PRODUCTS: STENTS-XIENCE PRIME 2.25X12 MM, PROMUS ELEMENT 2.25X20MM. (B)(4) - NOT LABELED. THE DEVICE IS NOT RETURNING. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER XIENCE PRIME DEVICE REFERENCED IS FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. EARLY ANEURYSM FORMATION AFTER EVEROLIMUS-ELUTING STENT IMPLANTATION (CIRC CARDIOVASCULAR INTERVENTIONS 2014;7:266-26, MITUL B. KADAKIA, MD ET AL.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED DEVICE MALFUNCTIONS OR PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ANEURYSM, CORONARY OR STENT EMBOLISM, ALLERGIC REACTION OR HYPERSENSITIVITY TO CONTRAST AGENT OR COBALT, CHROMIUM, NICKEL, TUNGSTEN, ACRYLIC AND FLUOROPOLYMER, AND DRUG REACTIONS TO ANTIPLATELET DRUGS OR CONTRAST AGENT, CORONARY OR STENT THROMBOSIS, RESTENOSIS OF THE STENTED SEGMENT OF THE ARTERY, AND UNSTABLE OR STABLE ANGINA PECTORIS ARE LISTED IN THE XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. BASED ON THE ARTICLE INFORMATION, 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

    THIS EVENT IS CAPTURED BASED ON REVIEW OF AN ARTICLE "EARLY ANEURYSM FORMATION AFTER EVEROLIMUS-ELUTING STENT IMPLANTATION". IT WAS REPORTED THAT A PATIENT PRESENTED WITH NON ST-ELEVATION MYOCARDIAL INFARCTION AND A 60% PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) BIFURCATION LESION INVOLVING AN 80% LESION IN THE FIRST DIAGONAL BRANCH (D1) AND A 90% LESION IN THE FIRST OBTUSE MARGINAL ARTERY (OM1). A XIENCE PRIME 2.75X12MM STENT WAS SUCCESSFULLY IMPLANTED IN THE LAD AND A PROMUS ELEMENT STENT WAS SUCCESSFULLY IMPLANTED IN D1. A XIENCE PRIME 2.25X12MM WAS SUCCESSFULLY IMPLANTED IN OM1. THERE WAS NO ANGIOGRAPHIC EVIDENCE OF DISSECTION OR INCOMPLETE EXPANSION AFTER STENT PLACEMENT. THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. SEVENTEEN DAYS LATER PATIENT PRESENTED WITH CHEST PAIN, NEW ANTERIOR T-WAVE INVERSIONS ON ECG, AND TNT OF 0.24 NG/ML. CATHETERIZATION SHOWED ANEURYSM FORMATION AT THE LAD AND OM1 STENT SITES WITH OCCLUSION OF A DISTAL LAD BRANCH, SUGGESTIVE OF LOCALIZED HYPERSENSITIVITY VASCULITIS WITH THROMBUS FORMATION WITHIN THE ANEURYSM AND EMBOLIZATION TO THE DISTAL LAD. CORONARY ARTERY BYPASS SURGERY WAS PERFORMED TO THE LAD, D1 AND OM1. DURING SURGERY GROSS EXAMINATION OF THE HEART SURFACE NOTED THE EPICARDIAL TISSUE AND FAT WERE HIGHLY INFLAMED, ERYTHEMATOUS AND INDURATED. SIX MONTH FOLLOW-UP CATHETERIZATION SHOWED SLIGHTLY DIMINISHED LAD ANEURYSM AND PATENT GRAFTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340871 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention