BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM

    MDR report key: 4112031 · Received September 23, 2014

    Report

    Report Number
    2024168-2014-06155
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 31, 2014
    Report Date
    September 1, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE STENT REMAINS IN THE VESSEL. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF DISSECTION, AS LISTED IN THE XIENCE PRO EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU), IS A KNOWN PATIENT EFFECT THAT MAY BE ASSOCIATED WITH USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY. THE XIENCE PRO IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE US. THE PRODUCT LISTED IN AND THE PMA# LISTED ARE BASED ON THE PREDICATE DEVICE (XIENCE V) AND IS THEREFORE SIMILAR TO A DEVICE SOLD IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A RADIAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE MODERATELY TORTUOUS, ECCENTRIC, 85% STENOSED, MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AFTER PREDILATATION WITH A 2.0 X 12 MM UNSPECIFIED BALLOON DILATATION CATHETER (BDC) THE 3.0 X 18 MM XIENCE PRO STENT WAS DELIVERED; HOWEVER, A DISTAL EDGE DISSECTION WAS NOTED. A SECOND XIENCE PRO STENT WAS USED AS TREATMENT WITHOUT REPORTED ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590558 XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4030341

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention