BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3191365 · Received June 26, 2013

    Report

    Report Number
    2024168-2013-04001
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: OTHER: 5.5FR AND 6FR VASCULAR SOLUTIONS GUIDELINER GUIDING CATHETER EXTENSION DEVICE. (B)(4) - RE-INSERTION. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. DIFFICULT TO POSITION (GUIDING CATHETER/GUIDE CATHETER EXTENSION RESISTANCE) WAS CONFIRMED. BASED ON 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 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/RACER XL EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE STATES: AN UNEXPANDED STENT MAY BE RETRACTED INTO THE GUIDING CATHETER ONE TIME ONLY. AN UNEXPANDED STENT SHOULD NOT BE REINTRODUCED INTO THE ARTERY ONCE IT HAS BEEN PULLED BACK INTO THE GUIDING CATHETER. SUBSEQUENT MOVEMENT IN AND OUT THROUGH THE DISTAL END OF THE GUIDING CATHETER SHOULD NOT BE PERFORMED, AS THE STENT MAY BE DAMAGED WHEN RETRACTING THE UNDEPLOYED STENT BACK INTO THE GUIDING CATHETER. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATTEMPT TO PERFORM DIRECT STENTING OF A HEAVILY CALCIFIED, DE NOVO LESION IN THE HEAVILY TORTUOUS MID RIGHT CORONARY ARTERY, A 3.5X38 RX XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED VIA FEMORAL ACCESS OVER AN UNSPECIFIED GUIDE WIRE THEN INTO A 5.5FR NON-ABBOTT GUIDE CATHETER EXTENSION DEVICE, HOWEVER, THE XPEDITION WAS UNABLE TO BE ADVANCED COMPLETELY THROUGH THE GUIDE CATHETER EXTENSION DEVICE DUE TO RESISTANCE FELT BETWEEN THE TWO DEVICES. NO ATTEMPT WAS MADE TO WITHDRAW THE XPEDITION FROM THE GUIDE CATHETER EXTENSION DEVICE, AND BOTH DEVICES WERE WITHDRAWN WITHOUT RESISTANCE FROM THE ANATOMY. THE 5.5FR GUIDE CATHETER EXTENSION DEVICE WAS EXCHANGED WITH A LARGER 6FR SIZED GUIDE CATHETER EXTENSION DEVICE. THE SAME 3.5X38 RX XIENCE XPEDITION WAS RE-ADVANCED INTO THE LARGER GUIDE CATHETER EXTENSION DEVICE, BUT WAS, AGAIN, UNABLE TO BE ADVANCED COMPLETELY THROUGH THE LARGER SIZED GUIDE CATHETER EXTENSION DEVICE DUE TO RESISTANCE FELT BETWEEN THE TWO DEVICES. NO ATTEMPT WAS MADE TO WITHDRAW THE XPEDITION FROM THE GUIDE CATHETER EXTENSION DEVICE, AND BOTH DEVICES WERE WITHDRAWN WITHOUT RESISTANCE FROM THE ANATOMY. THE LESION WAS THEN PRE-DILATED WITH AN UNSPECIFIED BALLOON DILATATION CATHETER, FOLLOWED BY SUCCESSFUL ADVANCEMENT AND DEPLOYMENT OF A NEW 3.0X38 RX XIENCE XPEDITION, WITHOUT THE USE OF A GUIDE CATHETER EXTENSION DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. THE ABBOTT VASCULAR RETURNED GOODS LAB RECEIVED THE XPEDITION WITH BALLOON PEELING/SHREDDING AT THE DISTAL END OF THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291435 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2112041

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR