BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1201809 · Received October 15, 2008

    Report

    Report Number
    2024168-2008-00951
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 15, 2008
    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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING DETERMINED THAT ANGINA AND RESTENOSIS, AS LISTED IN THE XIENCE V IFU IS A KNOWN RISK ASSOCIATED WITH CORONARY STENTING AND IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. IN THIS CASE, IT IS LIKELY THAT THE ANGINA IS A SECONDARY EFFECT OF THE RESTENOSIS WHICH RESULTED IN HOSPITALIZATION. HOWEVER, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE DEVICES, IF ANY, CANNOT BE DETERMINED. THE 3.0 X 18 MM XIENCE V MENTIONED IN THE EVENT DESCRIPTION IS BEING REPORTED UNDER THE SAME MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: RESTENOSIS REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR INJURY. DEVICE ISSUE: NONE. IT WAS REPORTED THAT THE CLINICAL TRIAL PROCEDURE WAS DONE IN EARLY 2008, TO TREAT A PATIENT WITH DOUBLE VESSEL DISEASE. FIRST, A 2.5 X 23 XIENCE V WAS PLACED IN THE 1ST OM. NEXT, THE MID RCA LESION WAS TREATED WITH A 3.0 X 28 XIENCE V; FOLLOWED BY THE PROXIMAL RCA LESION, WHICH WAS TREATED WITH A 3.5 18 XIENCE V. ON EIGHT MONTHS LATER, THE PATIENT RETURNED TO THE HOSPITAL, PRESENTED WITH CHEST PAIN. ANGIOGRAPHY WAS DONE, WHICH REVEALED RESTENOSIS OF THE PROXIMAL RCA AND THE 1ST OM. REVASCULARIZATION WAS PERFORMED AND TWO DRUG ELUTING STENTS WERE DEPLOYED ONE IN THE PROXIMAL RCA AND ONE IN THE 1ST OM. NO ADDITIONAL EVENT OR PATIENT INFORMATION 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention STENT: XIENCE V 3.0 X 18 MM (1009530-18 /LOT# UNK)