BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1730381 · Received June 18, 2010

    Report

    Report Number
    2024168-2010-01212
    Event Type
    Injury
    Date Received
    June 18, 2010
    Date of Event
    November 29, 2009
    Report Date
    May 26, 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
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA AND MYOCARDIAL INFARCTION (MI) ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. 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. THE 2.75 X 8 MM XIENCE V (PART 1009540-08, LOT 8111741), IS BEING FILED UNDER THIS MFR#.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: MYOCARDIAL INFARCTION REQUIRING INTERVENTION. ONSET OF ADVERSE EVENT: AFTER THE PROCEDURE. IT WAS REPORTED VIA TRIAL THAT ON (B)(6) 2009, THE PATIENT UNDERWENT STENTING IN THE PREDILATED CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH A 3.0 X 15 MM XIENCE V STENT. DURING THE PROCEDURE A SIDE BRANCH OCCLUSION IN THE SMALL DIAGONAL OCCURRED REQUIRING IMPLANTATION OF THE 2.75 X 8 MM XIENCE V STENT. ON (B)(6) 2009, THE PATIENT EXPERIENCED ISCHEMIC SYMPTOMS WITH ECG SHOWING ST DEPRESSION WHEN THE PATIENT AMBULATED. THE PATIENT UNDERWENT AN UNPLANNED PERCUTANEOUS CORONARY INTERVENTION ON (B)(6) 2009, IN THE NON-TARGET MID AND DISTAL RIGHT CORONARY ARTERIES. ABBOTT VASCULAR MEDICAL SAFETY MONITORS ASSESSED THIS EVENT AS A MYOCARDIAL INFARCTION CAUSED BY THE TARGET VESSEL. ON (B)(6) 2010, THE PATIENT EXPERIENCED CHEST PAIN WHILE WALKING THAT WAS UNRELIEVED WITH REST. ANGIOGRAPHY ON (B)(6) 2010, SHOWED A STENT THROMBOSIS. ON (B)(6) 2010, THE PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFT IN THE TARGET VESSEL AND THE NON-TARGET VESSEL. THE PATIENT WAS DISCHARGED ON (B)(6) 2010. 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 9050741

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R (LOT 8111741)| STENT: 2.75 X 8 MM XIENCE V (PART 1009540-08)