BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1784606 · Received July 29, 2010

    Report

    Report Number
    2024168-2010-01521
    Event Type
    Injury
    Date Received
    July 29, 2010
    Date of Event
    June 16, 2010
    Report Date
    June 19, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE XIENCE V 3.0 X 18 (PART 1009541-18, LOT 8052961), XIENCE V 3.0 X 8 (PART 1009541-08, LOT 8040961), XIENCE V 3.0 X 18 (PART 1009541-18, LOT 0030141), XIENCE V 3.0 X 15 (PART 1009541-15, LOT 9121741) INDICATED ARE BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. EVAL SUMMARY: THE REPORTED ANGINA AND STENOSIS ARE LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING AND ARE NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. ADDITIONALLY, ANGINA, STENOSIS, DYSPNEA AND HOSPITALIZATION ARE LISTED IN THE RISK ASSESSMENT MATRIX AS NO-FAULT COMPLICATIONS. REPORTEDLY, 3 XIENCE V STENTS WERE PLACED IN A RE-STENOSED VEIN GRAFT. IT SHOULD BE NOTED THAT THE IFU STATES "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". IT IS UNK IF IMPLANTING THE XIENCE V STENTS IN THE VEIN GRAFT CONTRIBUTED TO THE PATIENT EFFECTS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MFG OR DESIGN. ALL SDS ARE SUBJECTED TO A 100% VISUAL INSPECTION. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: IN-STENT RESTENOSIS. TIME OF ADVERSE EVENT: APPROX 1.5 MONTHS AND 20 MONTHS POST STENT IMPLANTATION. IT WAS REPORTED, VIA TRIAL, THAT APPROX 20 MONTHS POST, A RIGHT INTERNAL MAMMARY ARTERY (RIMA) GRAFT TO RIGHT CORONARY ARTERY (RCA) STENTING PROCEDURE, PLACING 3 XIENCE V STENTS IN A RESTENOSED GRAFT (INDEX PROCEDURE ON (B)(6) 2008), AND APPROX 1.5 MONTHS POST, A RCA STENTING PROCEDURE, PLACING 2 XIENCE V STENTS (INDEX PROCEDURE ON (B)(6) 2010), THE PT EXPERIENCED CHEST PAIN AND SHORTNESS OF BREATH UPON EXERTION. AN ANGIOGRAM PERFORMED ON (B)(6) 2010, FOUND APPROX 50% IN-STENT RESTENOSIS (ISR) WITHIN THE 3 XIENCE V STENTS LOCATED IN THE ARTERIAL GRAFT AND APPROX 90% ISR IN THE 2 STENTS PLACED IN THE RCA. THE ECG WAS NEGATIVE FOR MYOCARDIAL INFARCTION. NO TREATMENT WAS DONE FOR THE 3 STENTS; HOWEVER, ON (B)(6) 2010, A CUTTING BALLOON AND DRUG ELUTING STENTS WERE PLACED WITHIN THE 2 STENTS IN THE RCA. ON (B)(6) 2010, THE EVENT RESOLVED AND THE PT WAS DISCHARGED TO HOME. ALTHOUGH REQUESTED, THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8043061

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization XIENCE V 3.0 X 18 (PART 1009541-18, LOT 0030141)| XIENCE V 3.0 X 18 (PART 1009541-18, LOT 8052961)| XIENCE V 3.0 X 8 (PART 1009541-08, LOT 8040961)| XIENCE V 3.0 X 15 (PART 1009541-015, LOT 9121741)