BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3043557 · Received April 9, 2013

    Report

    Report Number
    2024168-2013-02106
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 19, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: (B)(4) - FAILURE TO FOLLOW STEPS/INSTRUCTIONS. THE DEVICE WAS RETURNED FOR EVALUATION. SHAFT SEPARATION WAS CONFIRMED. BASED ON VISUAL 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. IT SHOULD BE NOTED THAT THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE INSTRUCTS THE PHYSICIAN TO: DEFLATE THE BALLOON BY PULLING NEGATIVE ON THE INFLATION DEVICE FOR 30 SECONDS. CONFIRM COMPLETE BALLOON DEFLATION BEFORE ATTEMPTING TO MOVE THE DELIVERY SYSTEM. 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 TO TREAT THE MODERATELY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY (RCA), NO PRE-DILATATION WAS PERFORMED. A 3.5 X 15 MM XIENCE XPEDITION STENT DELIVERY SYSTEM WAS ADVANCED INTO THE PATIENT ANATOMY AND THE STENT WAS DEPLOYED AT THE TARGET LESION IN THE RCA. THE STENT DELIVERY SYSTEM WAS PULLED BACK TO THE OSTIUM OF THE RCA AND THE BALLOON WAS INFLATED TO PERFORM PRE-DILATATION AT A SECOND SITE; HOWEVER, IT WAS NOTED THAT THE DISTAL SHAFT OF THE STENT DELIVERY SYSTEM HAD SEPARATED. THE ENTIRE SYSTEM WAS THEN REMOVED AS A SINGLE UNIT AND THE SEPARATED SEGMENTS WERE REMOVED WITHOUT FURTHER INTERVENTION. THERE WAS NO REPORTED RESISTANCE NOTED DURING ADVANCEMENT AND NO RESISTANCE NOTED AT ANY TIME DURING WITHDRAWAL. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145084 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2111241

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR