BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1416880 · Received July 16, 2009

    Report

    Report Number
    2024168-2009-01257
    Event Type
    Injury
    Date Received
    July 16, 2009
    Date of Event
    May 6, 2009
    Report Date
    June 8, 2009
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SECOND XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM IS BEING REPORTED UNDER THE SAME MFR NUMBER. RESULTS AND CONCLUSION SUMMATION - ANGINA, AS LISTED IN THE XIENCE IFU IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING, AND NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE PRODUCT CANNOT BE DETERMINED. BASED ON ADDITIONAL INFORMATION, RESTENOSIS IS LISTED IN THE XIENCE IFU AS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING, AND NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: STENOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA TRIAL THAT THE INDEX PROCEDURE WAS IN 2008. PREDILATATION WAS PERFORMED PRIOR TO STENTING OF THE MID LAD WITH TWO XIENCE V STENTS. NO PROCEDURAL COMPLICATIONS WERE REPORTED. IN 2009, THE PATIENT CALLED THE DOCTOR OFFICE COMPLAINING OF EXERTIONAL CHEST PRESSURE. LEXASCAN GXT WAS PERFORMED ONE WEEK LATER SHOWING NO ST SEGMENT CHANGES AND A DIAGNOSTIC OF ISCHEMIA WAS MADE. A MODERATE DEFECT MID TO DISTAL ANTERIOR WALL, MINIMAL REVERSIBILITY IN THE ANTERIOR WALL. A HEART CATH WAS PLANNED FOR ABOUT THREE WEEKS. THE PATIENT HAD A POSITIVE FUNCTIONAL STRESS TEST. BALLOON ANGIOPLASTY WAS PERFORMED AND A DES STENT WAS PLACED IN THE PROXIMAL LAD ON THE DAY THE PT CALLED THE DOCTOR'S OFFICE. 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 71129P8

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R STENT: XIENCE V EVEROLIMUS ELUTING CORONARY STENT| SYSTEM (PART# 1009515-18