BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3884609 · Received June 19, 2014

    Report

    Report Number
    2024168-2014-03942
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 24, 2014
    Report Date
    May 27, 2014
    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). THROMBOSIS, STENOSIS AND ANGINA ARE LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS 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 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

    IT WAS REPORTED THAT ON (B)(6) 2014 A 2.25X23 MM XIENCE PRIME STENT WAS DEPLOYED IN A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. ON (B)(6) 2014, PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED TO THE PROXIMAL CIRCUMFLEX THAT WAS 100% STENOSED, WITH MILD TORTUOSITY AND HEAVY CALCIFICATION. AFTER PRE DILATATION WITH NON-ABBOTT BALLOON, A 2.5X12 MM XIENCE XPEDITION WAS DEPLOYED AT 10 ATMOSPHERES. POSTDILATATION WAS PERFORMED WITH A 2.5X8 MM NC TREK BALLOON CATHETER AS ROUTINE PROCEDURE. GOOD DEPLOYMENT OF THE STENT WAS CONFIRMED BY INTRAVASCULAR ULTRASOUND. ON (B)(6) 2014, THE PATIENT WAS TAKEN TO THE HOSPITAL DUE TO CHEST PAIN. HEPARIN 20,000 WAS ADMINISTERED. ANGIOGRAPHY ON (B)(6) 2014 NOTED RESTENOSIS AT BOTH EDGES OF THE IMPLANTED STENT IN THE CIRCUMFLEX. AFTER PREDILATATION WAS PERFORMED A NON-ABBOTT DRUG ELUTING STENT WAS DEPLOYED DISTAL TO THE XIENCE XPEDITION STENT, OVERLAPPING THE STENT. THE PROXIMAL EDGE OF THE STENT WAS TREATED WITH BALLOON ANGIOPLASTY. THE PATIENT REMAINS IN THE HOSPITAL; HOWEVER, FOR PLANNED UNRELATED TREATMENT OF THE LOWER EXTREMITY. PHYSICIAN COMMENTED THAT THE STENOSIS WAS LIKELY RESTENOSIS AS THE PLAQUE WAS HARD; HOWEVER, IT WAS IMPOSSIBLE TO RULE OUT THROMBOSIS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361025 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3062742

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R STENT: 2.25X23 MM XIENCE PRIME