BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2962632 · Received February 14, 2013

    Report

    Report Number
    2024168-2013-00883
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 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
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE RIGHT CORONARY ARTERY, PRE-DILATATION WAS PERFORMED USING MULTIPLE TREK BALLOONS DUE TO HEAVY CALCIFICATION/TORTUOSITY. ATTEMPTS WERE MADE TO ADVANCE THREE RX XIENCE XPEDITION STENT SYSTEMS, 3.5X23, 3.25X8, AND 2.25X12 RESPECTIVELY. ALL THREE STENT SYSTEMS COULD NOT CROSS DUE TO THE HEAVY CALCIFICATION AND TORTUOSITY OF THE VESSEL. AFTER ATTEMPTED ADVANCEMENT OF THE SECOND STENT SYSTEM (3.25X8), A DISSECTION WAS NOTED. THERE WAS NO REPORTED FORCE APPLIED TO THE STENT SYSTEM. EXTENDED BALLOON DILATATION WAS PERFORMED TO SUCCESSFULLY TREAT THE DISSECTION. DUE TO THE INABILITY OF ANY STENT SYSTEM (INCLUDING NON-ABBOTT STENT SYSTEMS) TO CROSS TO THE TARGET SITE, THE LESION WAS ULTIMATELY TREATED WITH BALLOON ANGIOPLASTY ONLY, RESULTING IN TIMI FLOW 4. ALTHOUGH THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE, THERE WAS NO ADVERSE PATIENT SEQULEA. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65548 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2091841

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention GUIDE CATHETER: 6F AL1, GUIDELINER