BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1961902 · Received January 14, 2011

    Report

    Report Number
    2024168-2011-00328
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    February 18, 2010
    Report Date
    December 20, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - INCORRECT ANATOMY; NO PRE-DILATATION; USE AFTER EXPIRATION. STENT- XIENCE V 4.0 X 28 MM (PART#1009543-28/LOT#8062561/SERIAL#(B)(4)); XIENCE V 4.0 X 28 MM (PART#1009543-28/LOT#7101661/SERIAL#(B)(4)) THE XIENCE V 4.0 X 28 MM (PART#1009543-28/LOT#8062561/SERIAL#(B)(4))AND XIENCE V 4.0 X 28 MM (PART#1009543-28/LOT#7101661/SERIAL#(B)(4)) ARE BEING FILED UNDER SEPARATE MANUFACTURER REPORT NUMBERS. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF ANGINA, NAUSEA AND RESTENOSIS, AS LISTED IN THE PRODUCT INSTRUCTIONS FOR USE (IFU), ARE KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. 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. REVIEW OF THE LABEL ATTACHMENTS FOR THE LOT HISTORY RECORD (LHR) REVEALED AN EXPIRATION DATE (USE BY DATE) OF 11/5/2008, WHICH IS 365 DAYS (OR 1 YEAR) AS SPECIFIED IN THE PRODUCT SPECIFICATION AT THE TIME THIS LOT WAS MANUFACTURED. THIS CONFIRMS THAT THE PRODUCT WAS LABELED CORRECTLY. THEREFORE, BASED ON THE REPORTED INFORMATION, THE PRODUCT WAS USED 8 DAYS PAST THE LABELED EXPIRATION DATE. HOWEVER, IN (B)(6) 2009, COMMERCIALLY AVAILABLE XIENCE V PRODUCT IN THE US RECEIVED APPROVAL FOR A 2 YEAR SHELF LIFE. SO, ALTHOUGH THE SPECIFIC UNIT INVOLVED IN THIS CASE WAS EXPIRED AT THE TIME OF USE (LABELED WITH 1 YEAR SHELF-LIFE); A PORTION OF THIS LOT HAD BEEN RELABELED WITH THE APPROVED 2 YEAR SHELF LIFE, HAVING AN EXPIRATION DATE OF (B)(6) 2009. THE EXPIRATION DATE OF THE PRODUCT IS IMPORTANT FOR THE STERILITY, EFFICACY AND PERFORMANCE OF THE DEVICE. IT SHOULD BE NOTED THAT THE XIENCE V INSTRUCTIONS FOR USE (IFU) STATES: DO NOT USE AFTER THE USE BY DATE. FURTHERMORE, IT WAS REPORTED THAT THE STENT DELIVERY SYSTEM WAS DELIVERED WITHOUT PRE-DILATATION (DIRECT STENTING) TO TREAT A LESION IN THE SAPHENOUS VEIN GRAFT (SVG). IT SHOULD BE NOTED THAT THE IFU STATES, 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 FURTHER MENTIONS THAT, THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (XIENCE V STENT) 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 4.25 MM. THE SAFETY AND EFFECTIVENESS OF THE XIENCE V STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH LESIONS LOCATED IN SAPHENOUS VEIN GRAFTS.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2008, THE PATIENT UNDERWENT STENTING IN THE SAPHENOUS VEIN GRAFT WITH THREE XIENCE V STENTS, TWO 4.0 X 28 MM AND ONE 4.0 X 18 MM. ON (B)(6) 2010, THE PATIENT EXPERIENCE NAUSEA, VOMITING, SHORTNESS OF BREATH WITH EXERTION AND SHORT EPISODES OF CHEST PRESSURE. ON (B)(6) 2010, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY REVASCULARIZATION OF THE INDEX TARGET LESION FOR IN-STENT RESTENOSIS. THE PATIENT'S CONDITION RESOLVED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS 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 7102961

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R