BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3000398 · Received March 12, 2013

    Report

    Report Number
    2024168-2013-01414
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS INITIALLY REPORTED AS RETURNING, BUT HAS NOW BEEN REPORTED AS NOT RETURNING BECAUSE IT WAS DISCARDED AT THE ACCOUNT. 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET AREA WAS A TOTALLY OCCLUDED, THROMBOTIC LESION IN THE PROXIMAL TO MID RIGHT CORONARY ARTERY (RCA). RECANALIZATION WAS PERFORMED WITH A NON-ABBOTT GUIDE WIRE AND A 1.5 X 15 MM NON-ABBOTT BALLOON. AFTER PRE-DILATATION WITH A 2.0 X 30 MM NON-ABBOTT BALLOON, A 3.5 X 28 MM XIENCE XPEDITION STENT WAS POSITIONED WITH SUCCESS AND IMPLANTED. POST STENT DEPLOYMENT, DURING RETRACTION OF THE STENT DELIVERY SYSTEM (SDS) RESISTANCE WAS ENCOUNTERED. AT THE LEVEL OF GUIDE CATHETER ENTRY, RESISTANCE WAS EXPERIENCED AGAIN AND THE DISTAL SHAFT BECAME SEPARATED FROM THE PROXIMAL PART. NO INTERVENTION WAS REQUIRED TO REMOVE THE SEPARATED PORTION. IT WAS REMOVED AS A UNIT WITH THE GUIDE WIRE AND GUIDE CATHETER. THE GUIDE CATHETER WAS RE-POSITIONED AND THE SAME GUIDE WIRE WAS USED TO COMPLETED THE PROCEDURE BY IMPLANTING A 3.5 X 16 MM NON-ABBOTT STENT NEXT TO THE FIRST STENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103795 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2071041

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: SION