BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1730382 · Received June 18, 2010

    Report

    Report Number
    2024168-2010-01211
    Event Type
    Injury
    Date Received
    June 18, 2010
    Date of Event
    April 17, 2010
    Report Date
    May 25, 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 RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN 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: RESTENOSIS REQUIRING SURGICAL 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. 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)