BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3180780 · Received June 20, 2013

    Report

    Report Number
    2024168-2013-03841
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 25, 2013
    Report Date
    May 28, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE WIRE: RUNTHROUGH; GUIDE CATH: CORSAIR. (B)(4) - EXCESSIVE FORCE. THE STENT DELIVERY SYSTEM WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED ENTRAPMENT OF DEVICE/COMPONENT, DEVICE DAMAGED BY ANOTHER DEVICE, AND STENT SHORTENING ARE CONFIRMED VIA CINE. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE AND CINE REVIEW, 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. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT SHOULD BE NOTED THAT THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE STATES: APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OF OR DAMAGE TO THE STENT AND / OR DELIVERY SYSTEM COMPONENTS. IN THIS CASE, THE APPLICATION OF FORCE APPEARS TO HAVE CONTRIBUTED TO THE STENT IMPLANT BECOMING ACCORDIONED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS WAS AN EMERGENCY PROCEDURE TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. THREE XIENCE XPEDITION STENTS WERE IMPLANTED. DURING REMOVAL OF A NON-ABBOTT GUIDE WIRE, RESISTANCE WAS NOTED WITH THE DISTAL XIENCE XPEDITION STENT. THE GUIDE WIRE WAS PULLED WITH FORCE, AND THE STENT BECAME SHORTENED. A 1.2 MM BALLOON WAS ADVANCED IN ATTEMPT TO FREE THE GUIDE WIRE, BUT WAS UNSUCCESSFUL. A MICRO-CATHETER WAS THEN ADVANCED AND THE GUIDE WIRE WAS REMOVED; HOWEVER, THE TIP SEPARATED AND REMAINED LODGED IN THE STENT. WHILE REMOVING THE GUIDING CATHETER AND GUIDE WIRE, IT WAS OBSERVED THAT A PERFORATION HAD OCCURRED IN THE PROXIMAL RCA. IT IS UNKNOWN WHEN THE PERFORATION OCCURRED. A 3.0 X 19 MM GRAFTMASTER STENT WAS USED TO TREAT THE PERFORATION SUCCESSFULLY. THE PATIENT HAD A GOOD OUTCOME AND WAS DISCHARGED. IT WAS NOTED THAT THE PHYSICIAN BELIEVED THAT THE STENT BECAME DAMAGED DUE TO THE TIP SHAPE OF THE NON-ABBOTT GUIDE WIRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280193 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2112041

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR