BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3092805 · Received May 3, 2013

    Report

    Report Number
    2024168-2013-02783
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. FAILURE TO CROSS/RESISTANCE IN THE LESION COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. THE INFLATION AND DEPLOYMENT ISSUES WERE CONFIRMED. DISTAL BALLOON LEAK WAS NOT CONFIRMED; HOWEVER, PROXIMAL SHAFT LEAK WAS NOTED. BASED ON VISUAL AND FUNCTIONAL ANALYSIS 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRE-DILATATION WAS PERFORMED WITH A TREK BALLOON DILATATION CATHETER (BDC) VIA ONE INFLATION TO NOMINAL PRESSURE. A 2.5X8 XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS THEN ADVANCED VIA FEMORAL ACCESS TO A HEAVILY CALCIFIED LESION IN THE MILDLY TORTUOUS PROXIMAL OBTUSE MARGINAL CORONARY ARTERY WITH RESISTANCE FELT AGAINST THE HEAVILY CALCIFIED LESION AND FORCE WAS APPLIED. WHEN ATTEMPTING TO INFLATE THE XPEDITION SDS, WHILE THE INDEFLATOR GAUGE DID NOT INDICATE ANY PRESSURIZATION OF THE SDS, A LEAK WAS OBSERVED AT THE DISTAL BALLOON SEAL AS BUBBLES WERE NOTED TO BE COMING FROM THAT AREA. ALTHOUGH NO PRESSURE WAS NOTED ON THE INDEFLATOR AND THE BALLOON WAS NOT OBSERVED TO EXPAND, THE STENT SLIGHTLY EXPANDED AT THE TARGET LESION SITE. THE UNINFLATED BALLOON WAS THEN GENTLY WITHDRAWN FROM THE SLIGHTLY EXPANDED STENT WITHOUT RESISTANCE, AND FROM THE ANATOMY WITHOUT RESISTANCE. A TREK BDC WAS THEN ADVANCED TO THE STENT, WHICH WAS COMPLETELY DEPLOYED USING THE INDEFLATOR, AT THE TARGET SITE, COMPLETING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194602 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2090441

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention INFLATION: INDEFLATOR