BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3936287 · Received July 15, 2014

    Report

    Report Number
    2024168-2014-04537
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION - IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS. SUBSEQUENT INFORMATION REVEALED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. 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. A QUERY OF THE COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FOR PHYSICAL RESISTANCE OR DISLODGED/DISLOCATED STENT FROM THIS LOT. IT SHOULD BE NOTED THAT THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: ALTHOUGH THE SAFETY AND EFFECTIVENESS OF TREATING MORE THAN ONE LESION PER CORONARY ARTERY WITH XIENCE XPEDITION STENTS HAVE NOT BEEN ESTABLISHED, IF THIS IS PERFORMED, PLACE THE STENT IN THE DISTAL LESION BEFORE THE PROXIMAL LESION IN ORDER TO MINIMIZE DISLODGEMENT RISK INCURRED BY TRAVERSING THROUGH DEPLOYED STENTS. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A FEMORAL ARTERY ACCESS APPROACH DURING A COMPLEX PROCEDURE OF THE MODERATELY TORTUOUS, MODERATELY CALCIFIED RAMUS ARTERY THE VESSEL WAS PREDILATATED AND A GUIDELINER CATHETER WAS USED AS THE 2.5 X 38 MM UNSPECIFIED STENT DELIVERY SYSTEM (SDS) COULD NOT BE ADVANCED BUT A DISSECTION OF THE CIRCUMFLEX/OBTUSE MARGINAL WAS NOTED FROM THE GUIDELINER. THE 2.5 X 38 MM XIENCE XPEDITION WAS ADVANCED AND DEPLOYED AND THE BALLOON WAS INFLATED FOR 5 MINUTES SEALING THE DISSECTION OF THE PROXIMAL VESSEL. A 2.25 X 12 MM XIENCE XPEDITION SDS WAS ADVANCED TO TREAT THE DISTAL VESSEL BUT CAUGHT AT AN ANATOMICAL BEND AND DURING THE ATTEMPT TO MANIPULATE THE SDS THE STENT IMPLANT DISLODGED ONTO THE GUIDE WIRE IN THE LEFT MAIN. WHILE THE GUIDE WIRE REMAINED IN PLACE A SMALL UNSPECIFIED BALLOON DILATATION CATHETER (BDC) WAS ADVANCED THROUGH THE STENT AND INFLATED. WHILE PULLING BACK THE BDC AND STENT THERE WAS INTERACTION WITH THE GUIDE CATHETER AND THE STENT DISLODGED OFF THE GUIDE WIRE INTO THE LEFT MAIN WHILE THE GUIDE WIRE WAS REMOVED FROM THE VESSEL. A GUIDE WIRE WAS EVENTUALLY POSITIONED ALONGSIDE OF THE DISLODGED STENT AND USING AN UNSPECIFIED BDC THE STENT WAS CRUSHED TO THE VESSEL WALL WITHOUT ISSUE. THE PATIENT REMAINED STABLE THROUGHOUT THE ENTIRE PROCEDURE AND HAD A GOOD OUTCOME. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412335 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4012841

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention GUIDE CATH: GUIDELINER, SHEATH: 6 FR