BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3120345 · Received May 20, 2013

    Report

    Report Number
    2024168-2013-03176
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 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). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. DIFFICULTY/RESISTANCE REMOVING THE DEVICE FROM THE GUIDING CATHETER POST-DEPLOYMENT WAS NOT CONFIRMED. BALLOON WRINKLE/BUNCHING WAS CONFIRMED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, A 4.0X15 RX XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED VIA FEMORAL ACCESS INTO A 6-FR NON-ABBOTT GUIDING CATHETER AND TO A MILDLY CALCIFIED LESION IN THE MILDLY TORTUOUS PROXIMAL LEFT CIRCUMFLEX CORONARY ARTERY WITHOUT RESISTANCE AND THE STENT WAS IMPLANTED WITHOUT ISSUE. AFTER THE BALLOON WAS COMPLETELY DEFLATED WITHOUT ISSUE, THE SDS WAS THEN WITHDRAWN FROM THE VESSEL WITHOUT RESISTANCE, HOWEVER, WHEN REACHING THE GUIDING CATHETER, RESISTANCE WAS FELT BETWEEN THE XPEDITION BALLOON AND THE DISTAL END OF THE GUIDING CATHETER AND, THOUGH NO FORCE WAS APPLIED, THE BALLOON BECAME WEDGED/STUCK INSIDE OF THE DISTAL END OF THE GUIDING CATHETER. BOTH THE XPEDITION SDS AND GUIDING CATHETER WERE REMOVED FROM THE ANATOMY AS A SINGLE UNIT. AFTER REMOVAL, THE DISTAL END OF THE BALLOON WAS ALSO NOTED TO HAVE BUNCHED AT THE END OF THE GUIDING CATHETER. THE PROCEDURE WAS CONSIDERED COMPLETED, AS INTRAVASCULAR ULTRASOUND CONFIRMED SATISFACTORY STENT WALL APPOSITION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION RECEIVED INDICATED THAT A BALANCE MIDDLEWEIGHT (BMW) UNIVERSAL GUIDE WIRE HAD BEEN WITHDRAWN ALONG WITH THE 4.0X15 RX XIENCE XPEDITION STENT DELIVERY SYSTEM AND NON-ABBOTT GUIDING CATHETER ALL AS A SINGLE UNIT, BUT THAT THERE WAS NO ISSUE WITH THE BMW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222285 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2111241

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDING CATHETER: 6-FR MEDTRONIC| GUIDE WIRE: BMW