BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3021489 · Received March 26, 2013

    Report

    Report Number
    2024168-2013-01726
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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: THE DEVICE WAS RETURNED FOR EVALUATION. FAILURE TO ADVANCE/CROSS THE LESION COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. SHAFT SEPARATION WAS CONFIRMED. BASED ON VISUAL AND DIMENSIONAL 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 THE PATIENT UNDERWENT A STENTING PROCEDURE TO TREAT A LESION IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. PRE-DILATATION WAS PERFORMED USING A 2.5 X 15 MM TREK DILATATION CATHETER. THE PHYSICIAN ADVANCED THE 2.75 X 28 MM VISION STENT DELIVERY SYSTEM INTO THE PATIENT ANATOMY; HOWEVER, DUE TO THE PATIENT ANATOMY, THE DEVICE WAS UNABLE TO CROSS TO THE TARGET LESION AND WAS REMOVED WITHOUT DIFFICULTY. A 2.5 X 28 MM MINI VISION STENT DELIVERY SYSTEM WAS THEN ADVANCED; HOWEVER, THIS DEVICE WAS ALSO UNABLE TO CROSS AND WAS REMOVED WITHOUT DIFFICULTY. THE PHYSICIAN THEN ADVANCED A 2.75 X 38 MM XIENCE XPEDITION STENT DELIVERY SYSTEM INTO THE PATIENT ANATOMY. DURING ADVANCEMENT, THE PHYSICIAN APPLIED A NORMAL AMOUNT OF FORCE AND THE SHAFT OF THE XIENCE XPEDITION SEPARATED ABOUT 8 1/2 TO 9 INCHES FROM THE HUB. THE PHYSICIAN WAS EASILY ABLE TO REMOVE BOTH SEPARATED SEGMENTS. A 2.75 X 08 MM XIENCE XPEDITION WAS THEN ADVANCED; HOWEVER, THIS DEVICE WAS ALSO UNABLE TO CROSS AND WAS REMOVED WITHOUT DIFFICULTY. THE PHYSICIAN THEN ADVANCED A 3.0 X 23 MM XIENCE XPEDITION AND THIS DEVICE WAS ABLE TO CROSS TO THE TARGET LESION. THE STENT WAS DEPLOYED. 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
    123124 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2101641

    Patients

    Seq Age Sex Outcome Treatment
    1