BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2010887 · Received March 8, 2011

    Report

    Report Number
    2024168-2011-01519
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    November 9, 2010
    Report Date
    February 16, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. REPORTED (B)(4): NO PRE-DILATATION, DIRECT STENTING THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECTS OF ANGINA AND RESTENOSIS, AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU) ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED; THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. IT WAS REPORTED THAT THE STENT DELIVERY SYSTEM WAS DELIVERED WITHOUT PRE-DILATATION (DIRECT STENTING) OF THE LESION DURING THE INDEX PROCEDURE. IT SHOULD BE NOTED THAT THE IFU STATES, THE VESSEL SHOULD BE PRE-DILATED WITH AN APPROPRIATE SIZED BALLOON. FAILURE TO DO SO MAY INCREASE THE DIFFICULTY OF STENT PLACEMENT AND CAUSE PROCEDURAL COMPLICATIONS. IT IS NOT KNOWN HOW DIRECT STENTING CONTRIBUTED TO THE REPORTED PATIENT EFFECTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY TWENTY FIVE MONTHS POST DIRECT STENTING PROCEDURE IN THE DISTAL RIGHT CORONARY ARTERY WITH ONE 3.0 X 15 XIENCE V STENT, THE PATIENT EXPERIENCED CHEST PAIN ON (B)(6) 2009. ON (B)(6) 2010, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY REVASCULARIZATION FOR IN-STENT RESTENOSIS IN THE MID RIGHT CORONARY ARTERY. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2010 AND THE PATIENT WAS DISCHARGED. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, 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 8052161

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R