BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM

    MDR report key: 3002931 · Received March 13, 2013

    Report

    Report Number
    2024168-2013-01457
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 26, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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. BASED ON THE REPORTED INFORMATION, IT IS LIKELY THAT DURING THE ATTEMPT TO REMOVE THE DEVICE IT INADVERTENTLY INTERACTED WITH THE LESION CAUSING PLAQUE SHIFT, RESULTING IN VESSEL OCCLUSION. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE XIENCE PRO IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE U.S. THE PRODUCT CODE LISTED AND THE PMA# LISTED IS BASED ON THE PREDICATE DEVICE (XIENCE V) AND IS THEREFORE SIMILAR TO A DEVICE SOLD IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE CIRCUMFLEX ARTERY (CX) WHICH WAS HEAVILY CALCIFIED. PRE-DILATATION WAS PERFORMED AND THE 3.5 X 28 MM XIENCE PRO WAS ADVANCED, BUT WAS UNABLE TO CROSS THE TARGET LESION AND BECAME STUCK INSIDE THE STENOSIS (DUE TO STENOSIS CONDITIONS, VESSEL KINKING). THE REMOVAL OF THE XIENCE PRO DEVICE CAUSED PLAQUE MATERIAL MOBILIZATION RESULTING IN THE VESSEL CLOSING OFF. AFTER REMOVAL OF THE XIENCE PRO, THE PATIENT MOVED CAUSING THE GUIDE WIRE AND GUIDE CATHETER TO SLIP OUT OF THE VESSEL. BOTH THE GUIDE WIRE AND THE GUIDE CATHETER WERE REMOVED FROM THE PATIENT AND RECANALIZATION WAS A NEW GUIDE AND A NEW GUIDING CATHETER. THREE SHORTER XIENCE PRO STENTS (3.0X18MM, 3.5X18MM, 3.0X18MM) WERE SUCCESSFULLY IMPLANTED TO COMPLETE THE PROCEDURE. THE POST-STENOSIS WAS 20% AND THERE WERE NO ADVERSE PATIENT EFFECTS. THE PHYSICIAN STATED THAT THERE HAD BEEN NO DEVICE DEFICIENCY AND THAT THE PATIENT ANATOMY WAS RESPONSIBLE FOR THE FAILURE TO CROSS AND THAT THE VESSEL CLOSURE WOULD HAVE OCCURRED WITH ANY OTHER DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104819 XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2112741

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE WIRE: BMW UNIVERSALGUIDE CATH: MEDTRONIC