BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3020007 · Received March 25, 2013

    Report

    Report Number
    2024168-2013-01699
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). GUIDE WIRE: EEL SLENDER; GUIDE CATHETER: HEARTRAIL 5F IL4; MICRO CATHETER: KIWAMI. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED AND THE REPORTED DIFFICULTY RETRACTING THE SDS COULD NOT BE REPLICATED AS THE RETURNED DEVICE WAS NOT RETURNED IN A CONDITION IN WHICH THE TEST COULD BE PERFORMED. ADDITIONALLY, THE REPORTED PHYSICAL LESION RESISTANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON THE VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NONCONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY FOR THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE XIENCE PRIME INSTRUCTIONS FOR USE (IFU) STATES: DEFLATE SLOWLY THE BALLOON BY PULLING NEGATIVE PRESSURE ON THE INFLATION DEVICE FOR 30 SECONDS. CONFIRM COMPLETE BALLOON DEFLATION BEFORE ATTEMPTING TO MOVE THE DELIVERY SYSTEM. IF UNUSUAL RESISTANCE IS FELT DURING STENT DELIVERY SYSTEM WITHDRAWAL, PAY PARTICULAR ATTENTION TO THE GUIDING CATHETER POSITION. IT WAS ALSO NOTED THAT THE INNER DIAMETER OF THE RETURNED MICROCATHETER WAS 0.049IN. THE INSTRUCTION FOR OPERATION/INSTRUCTION FOR USE SECTION OF THE IFU ADDITIONALLY INSTRUCTS THE USER TO USE GUIDING CATHETERS OF 5F OR LAGER. AS INDICATED ON THE PRODUCT LABEL, THE MINIMUM INNER DIAMETER OF THE 5F GUIDING CATHETER IS 0.056IN. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, AFTER CONFIRMING A REFERENCE VESSEL DIAMETER OF 3.7 MILLIMETERS VIA QUANTITATIVE CORONARY ANGIOGRAPHY AND AFTER PERFORMING PLAIN OLD BALLOON ANGIOPLASTY (POBA) USING A 2.5X12 TREK BALLOON DILATATION CATHETER (BDC) VIA ONE INFLATION TO 8 ATMOSPHERES (ATM) FOLLOWED BY A 2ND INFLATION TO 10 ATM, A 3.5X18 RX XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED VIA RADIAL ACCESS TOWARD A MILDLY CALCIFIED, CONCENTRIC, DE NOVO, 90% STENOSED LESION IN THE TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY; AS THE ADVANCEMENT WAS DIFFICULT AND THE RX XIENCE PRIME WAS INITIALLY UNABLE TO CROSS THE LESION, A NON-ABBOTT MICROCATHETER WAS ADVANCED TO ASSIST THE RX XIENCE PRIME IN CROSSING THE LESION. AFTER CROSSING THE LESION, THE RX XIENCE PRIME STENT WAS DEPLOYED VIA TWO INFLATIONS TO 10, THEN 12 ATM. POST DEPLOYMENT, NEGATIVE PRESSURE WAS DRAWN FOR 20 SECONDS, HOWEVER, THE RX XIENCE PRIME SDS WAS UNABLE TO BE WITHDRAWN FROM THE DEPLOYED STENT. THE SDS WAS INFLATED ONCE TO 1 ATMOSPHERE; ATTEMPTED RETRACTION, WITH NEUTRAL PRESSURE, FAILED AGAIN. THE RX XIENCE PRIME SDS, GUIDE WIRE, AND GUIDING CATHETER WERE ALL ABLE TO BE WITHDRAWN FROM THE ANATOMY AS A SINGLE UNIT. AFTER PERFORMING INTRAVASCULAR ULTRASOUND (IVUS), THE PROCEDURE WAS CONSIDERED COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121805 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2051441

    Patients

    Seq Age Sex Outcome Treatment
    1 CONCOMITANT MEDICAL DEVICES