BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2120533 · Received June 10, 2011

    Report

    Report Number
    2024168-2011-04115
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    April 23, 2011
    Report Date
    May 18, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THROMBOSIS IS A KNOWN ADVERSE EVENT AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. THE OTHER XIENCE V STENTS ARE BEING REPORTED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA AND THROMBOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. SINCE IT WAS REPORTED THAT THE XIENCE V STENT WAS IMPLANTED IN A LESION LONGER THAN 28MM, IT SHOULD BE NOTED THAT THE XIENCE V IFU STATES: THIS DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH LESS THAN OR EQUAL TO 28 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.5 MM TO 3.75 MM. IN THIS CASE, THE REPORTED IFU DEVIATION DOES NOT APPEAR TO HAVE DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT EFFECTS THAT OCCURRED AFTER THE INDEX PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ANGIOGRAPHY CONFIRMED THROMBOSIS ON (B)(6) 2011 IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) AND THE DISTAL LEFT CIRCUMFLEX (LCX) ARTERIES WHERE XIENCE V STENTS WERE IMPLANTED. THE 2.5 X 28 MM AND 2.5 X 12 MM XIENCE V STENTS WERE IMPLANTED IN THE LAD ON (B)(6) 2011. THE 2.5 X 28 MM AND 2.75 X 15 MM XIENCE V STENTS WERE ALSO IMPLANTED AT THE BIFURCATION IN THE LCX ON (B)(6) 2011. BOTH VESSEL AND LESION SITES WERE CHARACTERIZED AS BEING NON-TORTUOUS, CONCENTRIC, MILDLY CALCIFIED, DE NOVO AND 90% STENOSED. THROMBOSIS WAS RESOLVED USING ASPIRATION AND ALSO BALLOON ANGIOPLASTY. THE PHYSICIAN SUSPECTS THAT THE EVENT MAY HAVE OCCURRED DUE TO PLAVIX NOT WORKING WELL WITH THE PATIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6), 2011 FOR CHEST PAIN. THE LEFT ANTERIOR DESCENDING ARTERY WAS 30 MM LONG AND THE LEFT CIRCUMFLEX LESION WAS 35 MM LONG.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R STENT: XIENCE V (X3)