BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1747568 · Received July 1, 2010

    Report

    Report Number
    2024168-2010-01318
    Event Type
    Injury
    Date Received
    July 1, 2010
    Date of Event
    May 5, 2010
    Report Date
    June 7, 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
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE OTW XIENCE V 3.5 X 15MM (PART #1009548-15/ LOT #9010761), OTW XIENCE V 3.0 X 23MM (PART #1009547-23/LOT #9061961), AND OTW XIENCE V 3.0 X 15MM (PART #1009547-15/LOT #9020261), MENTIONED ARE BEING FILED UNDER THE SAME MANUFACTURER NUMBER. EVALUATION SUMMARY: IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). ADDITIONALLY, ANGINA, RESTENOSIS, AND HOSPITALIZATION ARE LISTED IN THE RISK ASSESSMENT MATRIX AS NO-FAULT COMPLICATIONS. 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. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO A 100% VISUAL INSPECTION. IN ADDITION, A QUALITY CONTROL (Q.C.) AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    ADVERSE EVENT: RESTENOSIS REQUIRING INTERVENTION. ONSET OF ADVERSE EVENT: AFTER THE PROCEDURE. DEVICE ISSUE: NONE. IT WAS REPORTED VIA A TRIAL THAT ON (B) (6) 2009, THE PATIENT UNDERWENT STENTING IN THE PREDILATED PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH TWO XIENCE V STENTS, DIRECT STENTING IN THE DISTAL RCA WITH ONE XIENCE V STENT, AND DIRECT STENTING IN THE RESTENOSED, DISTAL LEFT CIRCUMFLEX ARTERY WITH ONE XIENCE V STENT. ON (B) (6) 2010, THE PATIENT EXPERIENCED ANGINA AND UNDERWENT DIAGNOSTIC CORONARY ANGIOGRAPHY WITH PERCUTANEOUS CORONARY INTERVENTION TO REVASCULARIZE NEW LESIONS IN THE OSTIAL RCA AND IN-STENT RESTENOSIS IN THE LEFT CIRCUMFLEX. THE ANGIOGRAM SHOWED THE STENTS IN THE RCA WERE PATENT. THE PATIENT'S CONDITION RESOLVED ON (B) (6) 2010 AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. 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 NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 9051261

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention 7F XB| OTW XIENCE V 3.0 X 15MM (1009547-15/LOT #9020261)| OTW XIENCE V 3.0 X 23MM (1009547-23/LOT #9061961)| 2.5 X 15 VOYAGER| QUANTUM VOYAGER| 014 TRAVERSE| OTW XIENCE V 3.5 X 15MM (1009548-15/ LOT #9010761)