BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3011549 · Received March 19, 2013

    Report

    Report Number
    2024168-2013-01584
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 23, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. (B)(4) - EXCESSIVE FORCE AND INDICATION FOR USE. CONCOMITANT MEDICAL PRODUCTS: PILOT 200; 7F JR, 7F AL1. EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. THE DIFFICULTY/RESISTANCE REMOVING THE DEVICE POST-DEPLOYMENT COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. THE SHAFT SEPARATION WAS CONFIRMED. TIP SEPARATION WAS NOTED. BASED ON THE VISUAL 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. A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: SHOULD UNUSUAL RESISTANCE BE FELT AT ANY TIME WHEN WITHDRAWING THE STENT TOWARDS THE GUIDING CATHETER, THE STENT DELIVERY SYSTEM AND THE GUIDING CATHETER SHOULD BE REMOVED AS A SINGLE UNIT. FAILURE TO FOLLOW THESE STEPS AND/OR APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OF OR DAMAGE TO THE STENT AND/OR DELIVERY SYSTEM COMPONENTS. ALSO, IT SHOULD BE NOTED THAT IFU STATES: SAFETY AND EFFECTIVENESS OF THE XIENCE XPEDITION STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH LESIONS LOCATED IN CHRONIC TOTAL OCCLUSIONS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH, ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED ANTEGRADE AND THEN THE CORSAIR MICROCATHETER WAS BEING ADVANCE RETROGRADE. AS THE CORSAIR WAS BEING TORQUED IT TWISTED THE TIP OF THE SDS AND THE TIP SEPARATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONICALLY TOTALLY OCCLUDED RIGHT CORONARY ARTERY (RCA). THE XIENCE XPEDITION WAS DELIVERED ANTEGRADE TO THE RCA AND DEPLOYED AT 14 ATMOSPHERES WITHOUT ISSUE. WHEN ATTEMPTING TO REMOVE THE STENT DELIVERY SYSTEM AFTER DEPLOYMENT, THERE WAS RESISTANCE AND THE GUIDING CATHETER WAS DEEP SEATED. THE GUIDING CATHETER WAS RE-POSITIONED; HOWEVER, THERE WAS STILL RESISTANCE TRYING TO PULL THE CATHETER INTO THE GUIDING CATHETER AND FORCE WAS APPLIED CAUSING THE SHAFT TO SEPARATE AT THE GUIDE WIRE EXIT NOTCH. PART OF THE SEPARATED PORTION WAS INSIDE THE GUIDING CATHETER. A BALLOON CATHETER WAS USED TO TRAP THE SEPARATED SHAFT INSIDE THE GUIDING CATHETER AND THE TWO DEVICES WERE REMOVED TOGETHER. THE PROCEDURE WAS STOPPED AT THIS TIME DUE TO THE LENGTH OF THE PROCEDURE. THERE WAS STILL NO FLOW DISTAL TO THE RCA. THERE WAS COLLATERAL FLOW. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED GOODS ANALYSIS REVEALED TO TIP WAS SEPARATED. IT WAS CONFIRMED THAT THE SEPARATION OCCURRED DURING THE PROCEDURE AND THE TIP REMAINS IN THE ANATOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114419 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2111641

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention MICROCATHETER: CORSAIR