BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4140833 · Received October 3, 2014

    Report

    Report Number
    2024168-2014-06417
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    August 8, 2014
    Report Date
    September 9, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE BALLOON RUPTURE WAS ABLE TO BE CONFIRMED. BASED ON A VISUAL AND FUNCTIONAL INSPECTION AND SCANNING ELECTRON MICROSCOPY (SEM) IMAGING 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 QUERY/REVIEW OF THE ELECTRONIC COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FOR BALLOON RUPTURES FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RAMUS CORONARY ARTERY STENTING PROCEDURE, DURING STENT DEPLOYMENT, THE 2.5 X 18 MM XIENCE XPEDITION BALLOON RUPTURED AT 15 ATMOSPHERES AND A SIGNIFICANT DISSECTION OCCURRED IN THE MID LEFT ANTERIOR DESCENDING (MLAD) CORONARY ARTERY. THE DISSECTION WAS TREATED WITH AN UNPLANNED STENT IN THE LAD. THE PATIENT WAS MONITORED IN THE INTENSIVE CARE UNIT FOR 24 HOURS. THREE DAYS POST PROCEDURE AN INTERVENTION WAS PERFORMED. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620669 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4010341

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R