BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1949190 · Received January 5, 2011

    Report

    Report Number
    2024168-2011-00031
    Event Type
    Injury
    Date Received
    January 5, 2011
    Date of Event
    June 10, 2010
    Report Date
    December 11, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. DEVICE CODE: 2017 - ABOVE RATED BURST PRESSURE, NO PRE-DILATATION, INCORRECT ANATOMY THE 2.5 X 18 MM XIENCE V (1009545-18, 8052961) IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA AND RESTENOSIS 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 OR DESIGN. REPORTEDLY, DIRECT STENTING OF THE SAPHENOUS VEIN GRAFT (SVG) WAS PERFORMED. ADDITIONALLY, THE BALLOON WAS INFLATED ABOVE THE RATED BURST PRESSURE (RBP). IT SHOULD BE NOTED THAT THE IFU INSTRUCTS THE USER THAT 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. THE IFU ALSO CAUTIONS THAT THE SAFETY AND EFFECTIVENESS OF THE XIENCE V STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH LESIONS LOCATED IN SAPHENOUS VEIN GRAFTS AND NOT TO EXCEED RATED BURST PRESSURE (RBP) AS INDICATED ON PRODUCT LABEL. BALLOON PRESSURES SHOULD BE MONITORED DURING INFLATION. APPLYING PRESSURES HIGHER THAN SPECIFIED ON THE PRODUCT LABEL MAY RESULT IN A RUPTURED BALLOON WITH POSSIBLE ARTERIAL DAMAGE AND DISSECTION. THE STENT INNER DIAMETER SHOULD APPROXIMATE 1.1 TIMES THE REFERENCE DIAMETER OF THE VESSEL. IT IS UNKNOWN HOW, IF AT ALL, DIRECT STENTING OF THE SAPHENOUS VEIN GRAFT (SVG) AND INFLATION ABOVE RBP MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2008, THE PATIENT UNDERWENT STENTING WITH TWO XIENCE V STENTS, ONE 2.5X18 IN THE FIRST OBTUSE MARGINAL CORONARY ARTERY AND ONE 4X28 IN THE SAPHENOUS VEIN GRAFT. ON (B)(6) 2010, THE PATIENT EXPERIENCED EXERTIONAL CHEST PAIN AND UNDERWENT PERCUTANEOUS CORONARY REVASCULARIZATION OF THE INDEX TARGET LESIONS . THE PATIENT'S CONDITION RESOLVED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, 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 8062561

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R STENT: 2.5 X 18 MM XIENCE V (1009545-18, 8052961)