BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1674937 · Received May 4, 2010

    Report

    Report Number
    2024168-2010-00912
    Event Type
    Injury
    Date Received
    May 4, 2010
    Date of Event
    November 1, 2009
    Report Date
    April 9, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA AND STENOSIS ARE RECOGNIZED AS KNOWN ADVERSE EVENTS OF CORONARY STENTING IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). THE POSITIVE FUNCTIONAL STRESS TEST (THE REPORTED TEST RESULTS) WAS LIKELY USED TO DIAGNOSE POTENTIAL ISCHEMIA, WHICH WAS POSSIBLY ATTRIBUTED TO THE RESTENOSIS OR NEW STENOSIS FOUND IN THE DIAGNOSTIC CORONARY ANGIOGRAPHY. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECTS AND THE RELATIONSHIP, IF ANY, TO THE DEVICES CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN. THE SECOND 3.0 X 8 MM XIENCE V (PART 1009553-08, LOT 6053151), HAS BEEN FILED UNDER THIS MFR NUMBER.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: ANGINA AND RESTENOSIS REQUIRING INTERVENTION. ONSET OF ADVERSE EVENT: AFTER THE PROCEDURE. IT WAS REPORTED VIA TRIAL THAT ON (B) (6) 2007, THE PT UNDERWENT STENTING IN THE PREDILATED DISTAL RIGHT CORONARY ARTERY (RCA) WITH ONE XIENCE V STENT AND IN THE PREDILATED MID RCA WITH ONE XIENCE V STENT. ON AN UNSPECIFIED DATE IN (B) (6) 2009, THE PT EXPERIENCED ANGINA AND A POSITIVE FUNCTIONAL STRESS TEST THAT WAS TREATED WITH DIAGNOSTIC CORONARY ANGIOGRAPHY ON (B) (6) 2009, AND FOUND A NEW LESION PROXIMAL TO THE INDEX PROXIMAL RCA STENT AND IN-STENT RESTENOSIS OF INDEX MID RCA STENT. THE PT UNDERWENT REVASCULARIZATION ON (B) (6) 2009, WITH FOUR ADDITIONAL OVERLAPPING XIENCE STENTS FROM PROXIMAL TO MID TO DISTAL RCA. THE PT'S SYMPTOMS RESOLVED ON (B) (6) 2009. NO ADDITIONAL INFORMATION WAS 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 60601P1

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR NC VOYAGER| INFLATION: EVEREST| GUIDE WIRE: FORTE| STENT:3.0X8MM XIENCE V(PART 1009553-08,LOT6053151)| DIL CATH: ANGIOSCUPLT| NC SPRINTER| QUANTUM MAVERICK| 3.5 X 10 MM CUTTING BALLOON