BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2022757 · Received March 17, 2011

    Report

    Report Number
    2024168-2011-01798
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    June 24, 2009
    Report Date
    December 1, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DIRECT STENTING PERFORMED, NO PRE-DILATATION. THE REPORTED ANGINA AND STENOSIS ARE LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. REPORTEDLY, THE XIENCE V STENT WAS IMPLANTED WITHOUT PRE-DILATING THE LESION. IT SHOULD BE NOTED THAT THE IFU STATES TO PRE-DILATE THE LESION WITH A PTCA CATHETER OF APPROPRIATE LENGTH AND DIAMETER FOR THE VESSEL/LESION TO BE TREATED. LIMIT THE LONGITUDINAL LENGTH OF PRE-DILATATION BY THE PTCA BALLOON TO AVOID CREATING A REGION OF VESSEL INJURY THAT IS OUTSIDE THE BOUNDARIES OF THE XIENCE V STENT. IN THIS CASE, THE DIRECT STENTING (NO PRE-DILATATION) DOES NOT APPEAR TO HAVE CONTRIBUTED TO THE REPORTED EVENT AS THE PATIENT EFFECTS DID NOT OCCUR UNTIL SEVEN MONTHS AFTER THE INITIAL PROCEDURE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, COULD NOT BE DETERMINED; THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING AND THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY SEVEN MONTHS POST STENTING PROCEDURE WITH ONE 3.0 X 12 XIENCE V STENT IN THE PROXIMAL CIRCUMFLEX ARTERY AND ONE 2.5 X 28 XIENCE V STENT IN THE DISTAL CIRCUMFLEX ARTERY, THE PATIENT EXPERIENCED CHEST PAIN, UNRELATED TO ACTIVITY WHICH WAS RELIEVED WITH SUBLINGUAL NITROGLYCERIN. ON (B)(6) 2009, THE PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY FOR IN-STENT RESTENOIS IN THE LEFT DISTAL CIRCUMFLEX ARTERY. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2009 AND THE PATIENT WAS DISCHARGED. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8050841

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R STENT: XIENCE V 3.0 X 12