BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1982426 · Received February 9, 2011

    Report

    Report Number
    2024168-2011-00781
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 15, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4): NO PRE-DILATATION THE STENT REMAINS INSIDE THE PATIENT. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS OF CORONARY STENTING LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). IT WAS FURTHER REPORTED THAT NO PRE-DILATATION WAS PERFORMED. IT SHOULD BE NOTED THAT THE IFU CAUTIONS: THE VESSEL SHOULD BE PRE-DILATED WITH AN APPROPRIATE SIZED BALLOON. FAILURE TO DO SO MAY INCREASE THE DIFFICULTY OF STENT PLACEMENT AND CAUSE PROCEDURAL COMPLICATIONS. IT IS UNKNOWN HOW, IF AT ALL, THE DIRECT STENTING MAY HAVE CONTRIBUTED TO THE REPORTED PATIENT EFFECTS OCCURRING APPROXIMATELY TWELVE MONTHS AFTER THE INDEX PROCEDURE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP, IF ANY, TO THE XIENCE V DEVICE CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2010, THE PATIENT UNDERWENT DIRECT STENTING IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH ONE 3.5 X 28 MM XIENCE V STENT. ON (B)(6) 2011, THE PATIENT EXPERIENCED CHEST PAIN RADIATING TO THE UPPER BACK AND LEFT ARM. ON (B)(6) 2011, THE PATIENT WAS SEEN IN THE EMERGENCY ROOM AND WAS FOUND TO HAVE AN ELEVATED TROPONIN LEVEL. ON (B)(6) 2011, THE PATIENT HAD A DIAGNOSTIC CORONARY ANGIOGRAM THAT FOUND SEVERE IN-STENT RESTENOSIS IN THE INDEX RCA, 99% LESION DISTAL TO THE STENT, AND 60 TO 70% STENOSIS IN THE NON-TARGET MID LEFT ANTERIOR DESCENDING ARTERY. ON (B)(6) 2011, THE PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT IN THE TARGET LESION AND A NON-TARGET LESION. THE EVENT RESOLVED ON (B)(6) 2011 UPON DISCHARGE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 810036J

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| S