BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1264067 · Received December 11, 2008

    Report

    Report Number
    2024168-2008-01363
    Event Type
    Injury
    Date Received
    December 11, 2008
    Date of Event
    November 19, 2008
    Report Date
    November 20, 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
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS SUMMATION - RESTENOSIS/ISCHEMIA AS LISTED IN THE XIENCE V IFU ARE KNOWN RISKS ASSOCIATED WITH CORONARY STENTING. IT IS LIKELY THE ISCHEMIA WAS A SYMPTOM/SECONDARY EFFECT OF THE RESTENOSIS. HOWEVER, CONCLUSIVE ROOT CAUSE FOR THE REPORTED PATIENT ISSUES, AND THE RELATIONSHIP TO THE DEVICES, IF ANY, CANNOT BE DETERMINED. THE THREE XIENCE V STENTS (LOT 8021441, LOT 8073141, LOT 8080141), PLACED DURING THE FIRST PROCEDURE, INDICATED ARE BEING FILED UNDER THE SAME MFR NUMBER.

    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 THAT THE INITIAL PROCEDURE WAS PERFORMED IN 2008. FOUR XIENCE V STENTS WERE SUCCESSFULLY PLACED FROM THE PROXIMAL TO DISTAL LAD. THE PATIENT RETURNED TO THE HOSPITAL ON THE FOLLOWING MONTH, WITH CONGESTIVE HEART FAILURE. THE MID LAD STENT HAD 50-60% PLAQUE PROLAPSED, AND THE STENTED LAD HAD LUMINAL IRREGULARITY FROM MORE DIFFUSE LESION. A 2.5 X 12 MM XIENCE V STENT WAS DEPLOYED AT THE MID LAD LEAVING 0% STENOSIS. A 2.5 X 15 MM XIENCE V STENT WAS PLACED AT THE DISTAL LAD AT THE GAP BETWEEN THE STENTS LEAVING 0% STENOSIS. THE FLOW HAD REDUCED TO TIMI 1 AND DID NOT IMPROVE WITH MEDICATION; THEREFORE, AN INTRA-AORTIC BALLOON PUMP WAS USED WITH 1:1 COUNTER PULSATION. THE ECHOCARDIOGRAM SHOWED IMPROVED MOTION OF THE DISTAL SEPTUM. THE PATIENT WAS TRANSFERRED IN STABLE CONDITION TO THE CRITICAL CARE UNIT FOR OBSERVATION. 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 8032741

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R 2.5X28MM XIENCE V (LOT 8021441)| 2.25X12MM XIENCE V (LOT 8073141)| GUIDE WIRE: PILOT 50| INFLATION: 20/30 INDEFLATOR STENT| DILATATION CATHETER: 2.5X18MM POWERSAIL| 2.25X28MM XIENCE V (LOT 8080141)