BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1142744 · Received August 27, 2008

    Report

    Report Number
    2024168-2008-00729
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 28, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SECOND XCIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INDICATED WILL BE FILED UNDER THE SAME MFR NUMBER. RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING DETERMINED THAT THROMBOSIS AND ANGINA, AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE, ARE KNOWN RISKS ASSOCIATED WITH CORONARY STENTING AND ARE NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. THERE WAS NO REPORT OF ANY DEVICE MALFUNCTION AT THE TIME OF THE STENT IMPLANTS. THE ANGINA WAS LIKELY THE RESULT OF THE THROMBOSIS WHICH WAS TREATED WITH AN ASPIRATION CATHETER; HOWEVER, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE DEVICES, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/ MEDICAL INTERVENTION. REPORTING RATIONALE: THROMBOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NONE. IT WAS REPORTED VIA A SPRIT TRIAL THAT A 2.75 X 18 XIENCE AND A 2.5 X 15 XIENCE WERE IMPLANTED IN THE MID LAD. THE PATIENT DEVELOPED CHEST PAIN BEFORE LEAVING THE CATH LAB TABLE. A LARGE BLOOD CLOT WAS FOUND ON THE STENT SITE AFTER ANOTHER ANGIOGRAPHY WAS PERFORMED. THE PATIENT WAS TREATED WITH MEDICATION. AN EXPORT ASPIRATION CATHETER WAS USED TO EVACUATE THE CLOT AND WAS RESOLVED THE SAME DAY. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 7102461

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention STENT: XIENCE V EVEROLIMUS ELUTING CORONARY STENT| SYSTEM (PART # 1009539-15