BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1903900 · Received November 20, 2010

    Report

    Report Number
    2024168-2010-02480
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    July 2, 2010
    Report Date
    October 26, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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) FOR NO PREDILATATION AND USE IN A RESTENOSED VESSEL. THE STENT REMAINS INSIDE THE PATIENT. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF ANGINA, RESTENOSIS AND MYOCARDIAL INFARCTION, AS LISTED IN THE PRODUCT INSTRUCTIONS FOR USE (IFU), ARE KNOWN ADVERSE EVENTS 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. REPORTEDLY, THE STENT DELIVERY SYSTEM WAS DELIVERED WITHOUT PRE-DILATATION (DIRECT STENTING) OF THE LESION TO TREAT RESTENOSIS. 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 IN-STENT RESTENOSIS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH, THE FOLLOWING INFORMATION WAS RECEIVED: ON (B)(6) 2010, THE PATIENT REPORTED HAVING APPROXIMATELY THREE EPISODES OF ANGINA PER DAY, OCCURRING WITH EXERTION. THE PATIENT WAS TREATED WITH MEDICATION AND ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED FOR PERCUTANEOUS CORONARY INTERVENTION TO THE TARGET LESION. THERE WAS NO ADVERSE SEQUELA AND ON (B)(6) 2010, THE PATIENT WAS DISCHARGED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2008, THE PATIENT UNDERWENT DIRECT STENTING IN THE RESTENOSED PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH ONE 3.0 X 12 XIENCE V STENT AND DIRECT STENTING IN THE DE NOVO DISTAL RCA WITH ONE 2.5 X 15 XIENCE V STENT. ON (B)(6) 2010, THE PATIENT EXPERIENCED CHEST PAIN AND WAS FOUND TO HAVE AN ELEVATED TROPONIN LEVEL. THE PATIENT WAS DIAGNOSED WITH A MYOCARDIAL INFARCTION. ON (B)(6) 2010, THE PATIENT UNDERWENT A DIAGNOSTIC CORONARY ANGIOGRAM AND BALLOON ANGIOPLASTY OF THE PROXIMAL RIGHT CORONARY ARTERY FOR IN-STENT RESTENOSIS. THE PATIENT WAS ALSO TREATED WITH MEDICATION. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2010, AND THE PATIENT WAS DISCHARGED. THERE WAS NO ADVERSE PATIENT SEQUELA. 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 8071561

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R| S