BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1408586 · Received June 26, 2009

    Report

    Report Number
    2024168-2009-01147
    Event Type
    Injury
    Date Received
    June 26, 2009
    Date of Event
    May 27, 2009
    Report Date
    June 1, 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
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS SUMMATION - ANGINA, MI AND STENOSIS ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. IT IS POSSIBLE THAT THE ANGINA, EKG/ECG CHANGES AND MI WERE SECONDARY EFFECTS OF THE STENOSIS WHICH REQUIRED FURTHER HOSPITALIZATION AND IS SCHEDULED FOR CABG. ULTIMATELY, ALTHOUGH THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, A DEFINITIVE CAUSE FOR THE PT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE XIENCE (1009542-28/8051341) IS BEING REPORTED UNDER THIS SAME MFR. THE XIENCE (1009542-23/8052641) IS BEING REPORTED UNDER MFR #2024168-2009-01143.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/SURGICAL INTERVENTION. REPORTING RATIONALE: RESTENOSIS REQUIRING SURGICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL THAT IN 2008, THE PT UNDERWENT STENTING OF THE PRE-DILATED MID LAD, 1ST DIAG AND PROX CX WITH A TOTAL OF 4 XIENCE V STENTS. IN 2009, THE PT PRESENTED TO THE ER AFTER 3 EPISODES OF CHEST PAIN, THE 3RD EPISODE NONRESPONSIVE TO NITROGLYCERIN. THE FOLLOWING MORNING, THE PT EXPERIENCED ANOTHER EPISODE OF CHEST PAIN ACCOMPANIED BY SIGNIFICANT, DIFFUSE ST DEPRESSIONS EVIDENT ON EKG. THE PT WAS DIAGNOSED WITH A NON-ST-ELEVATION MI. DIAGNOSTIC CORONARY ANGIOGRAM REVEALED IN-STENT RESTENOSIS WITHIN THE MID LAD AND STENOSIS WITHIN THE LEFT MAIN AND RIGHT CORONARY ARTERIES. A CORONARY BYPASS GRAFT IS SCHEDULED AS TREATMENT. NO ADDITIONAL EVENT OR PT 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 8052841

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R| S (P.N. 1009542-23/LOT # 8052641/SERIAL # UNK.| LOT # 8051341/SERIAL # UNK)| STENT: XIENCE V STENTS (P.N. 1009542-28