BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3170272 · Received June 14, 2013

    Report

    Report Number
    2024168-2013-03724
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 23, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: THE DEVICE WAS INITIALLY REPORTED AS RETURNING, BUT HAS NOW BEEN REPORTED AS NOT RETURNING. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROCEDURE WAS TO TREAT A PROXIMAL CIRCUMFLEX LESION WITH NO TORTUOSITY AND NO CALCIFICATION. THE 3.5 X 28 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED AND INFLATED FOR ONE INFLATION AT 14 ATMOSPHERES (ATM) TO SUCCESSFULLY IMPLANT THE STENT AT THE LESION. HOWEVER, POST STENT DEPLOYMENT, THE STENT DELIVERY SYSTEM (SDS) BALLOON COULD NOT BE FULLY DEFLATED. IT WAS NOTED THAT THE SDS BALLOON APPEARED TO HAVE A BULB OF CONTRAST AT THE DISTAL END THAT WOULD NOT COLLAPSE. DURING RETRACTION, RESISTANCE WAS ENCOUNTERED WITH THE GUIDING CATHETER; HOWEVER THE DEVICE WAS ABLE TO BE RETRACTED. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272040 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2120441

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR GUIDE CATH: 6FR JOHNSON & JOHNSON XB 3.5