BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3884171 · Received June 19, 2014

    Report

    Report Number
    2024168-2014-03932
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    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). CONCOMITANT PRODUCTS: GUIDE WIRE: BMW ELITE II; GUIDE CATHETER: MACH1 6F; STENT: XPEDITION 3.0 X 12. THE DEVICE WAS RETURNED FOR ANALYSIS. THE FAILURE TO ADVANCE AND DIFFICULTY TO REMOVE THE DEVICE WERE UNABLE TO BE REPLICATED IN A TESTING ENVIRONMENT AS THEY ARE BASED ON OPERATIONAL CIRCUMSTANCES. THE MATERIAL DEFORMATION/ FLARE STENT WAS CONFIRMED. BASED ON A VISUAL AND DIMENSIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY/ REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 3.0X12MM XIENCE XPEDITION STENT WAS IMPLANTED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) CORONARY ARTERY WITHOUT REPORTED ISSUE. DURING ADVANCEMENT OF A 2.5X23MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) TO THE DISTAL LCX, RESISTANCE WAS MET. THE SDS HAD BECOME STUCK ON THE MORE PROXIMAL, PREVIOUSLY IMPLANTED 3.0X12MM XIENCE STENT. THERE WAS DIFFICULTY REMOVING THE SDS AND MULTIPLE ATTEMPTS WERE MADE. ANOTHER UNSPECIFIED GUIDE WIRE WAS ADVANCED AND AN UNSPECIFIED BALLOON CATHETER INFLATED THE LCX. THE SDS WAS ABLE TO BE REMOVED AND REPORTEDLY, THERE WAS NO DAMAGE TO THE IMPLANTED 3.0X12MM XIENCE XPEDITION STENT. ONCE OUTSIDE THE ANATOMY, THE DISTAL STENT STRUTS WERE NOTED TO BE FLARED. BALLOON ANGIOPLASTY WAS PERFORMED IN THE DISTAL LCX, COMPLETING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359787 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4020641

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention