BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3841619 · Received May 30, 2014

    Report

    Report Number
    2024168-2014-03506
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 14, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED INFLATION ISSUE AND MATERIAL RUPTURE WERE ABLE TO BE CONFIRMED. BASED ON A VISUAL INSPECTION 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 OF THE ELECTRONIC COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FOR INFLATION ISSUE OR MATERIAL RUPTURE FROM THIS LOT. DISSECTION IS LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE (IFU) AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A FEMORAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE HEAVILY CALCIFIED, MODERATELY TORTUOUS, DISTAL TO MID CIRCUMFLEX ARTERY THE UNSPECIFIED XIENCE XPEDITION STENT WAS DELIVERED SUCCESSFULLY AT 20 ATMOSPHERE (ATM) TO THE DISTAL LESION. A SECOND 2.5 X 23 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS POSITIONED MID/DISTAL WITH MINIMAL OVERLAPPING WITH THE DISTAL STENT AND DURING STENT BALLOON INFLATION THE INDEFLATOR STRUGGLED TO INFLATE UP TO 14 AM WHEN A CONTRAST LEAK DISTALLY WAS NOTED. IT WAS NOTED THAT THE STENT WAS DEPLOYED AT 14 ATM. THE SDS WAS REMOVED FROM THE ANATOMY AND ANGIOGRAPHY REVEALED A SMALL PERFORATION TO THE MID/DISTAL CIRCUMFLEX; THERE WAS CONTRAST LEAKING FROM AN SDS DISTAL BALLOON PINHOLE. POST DILATATION WITH A NC COMPLIANT NON-ABBOTT BALLOON DILATATION CATHETER (BDC) WAS PERFORMED WITH A GOOD RESULT AFTER A FEW MINUTES AND THE PERFORATION SETTLED WITHOUT ANY FALSE ANEURYSM. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS REPORTED AS SUCCESSFUL AND THE PATIENT SUFFERED NO ADVERSE SEQUELA. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY POST PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318463 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3120241

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R