BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1591098 · Received January 26, 2010

    Report

    Report Number
    2024168-2010-00116
    Event Type
    Injury
    Date Received
    January 26, 2010
    Date of Event
    November 6, 2009
    Report Date
    January 1, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE SECOND RX XIENCE V 3.0 X 23 MM (PART# 1009541-23/LOT# 8061661) MENTIONED IS BEING FILED UNDER THE SAME MANUFACTURE NUMBER. IN THIS CASE, THERE WAS NO REPORTED DEFICIENCY. ANGINA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). FURTHER, THESE PT EFFECTS, ALONG WITH HOSPITALIZATION, ARE LISTED IN THE NO FAULT RISK ASSESSMENT AS NO-FAULT POST-PROCEDURE COMPLICATIONS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT 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.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: RESTENOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL THAT THE INDEX PROCEDURE WAS ON (B) (6) 2008 AND DURING THE PROCEDURE, A 3.0 X 23 MM XIENCE V STENT AND A 3.0 X 12 MM XIENCE V STENT BOTH WERE DEPLOYED IN THE PROXIMAL LAD LESION. THERE WERE NO PT OR PRODUCT ISSUES NOTED AT THE TIME OF THE PROCEDURE. HOWEVER, ON (B) (6) 2009, THE PT RETURNED WITH CHEST PAIN SIMILAR TO PREVIOUS PAIN, POSITIVE STRESS TEST. THE PT WAS GIVEN MEDICATION AND CAME IN FOR SCHEDULED CATH. DIAGNOSTIC CORONARY ANGIOGRAPHY WAS DONE AND PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED ON (B) (6) 2009, IN THE TARGET LESION (LESION TREATED AT INDEX PROCEDURE). THE PT WAS DISCHARGED FROM THE HOSPITAL ON (B) (6) 2009. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    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 7120561

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R RX XIENCE V 3.0 X 23 MM| (PART# 1009541-23/LOT# 8061661)