BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3183070 · Received June 21, 2013

    Report

    Report Number
    2024168-2013-03890
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 28, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4): NO PREDILATATION. 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. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT SHOULD BE NOTED THAT THE JAPAN XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE STATES: PRE-DILATE THE LESION WITH A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH MODERATE TORTUOSITY, MODERATE CALCIFICATION AND 90% STENOSIS. THE PATIENT WAS AN ACUTE MYOCARDIAL INFARCTION (AMI) PATIENT. DIRECT-STENTING OF THE 3.0 X 15 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED; HOWEVER RESISTANCE MET WITH THE UNSPECIFIED GUIDE WIRE DURING ADVANCEMENT. THUS, THE XIENCE PRIME SDS WAS RETRACTED, AND DURING RETRACTION THE GUIDE WIRE CAME OUT OF THE ANATOMY STUCK WITH THE XIENCE PRIME SDS. UPON REMOVAL FROM THE ANATOMY, CLOT WAS OBSERVED ON THE GUIDE WIRE AND THE GUIDE WIRE WAS WIPED DOWN AND RE-ADVANCED TO THE LESION. A NON-ABBOTT STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO CLINICALLY SIGNIFICANT DELAY OF THE PROCEDURE WAS REPORTED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE REPORTED CLOT NOTED ON THE GUIDE WIRE DURING REMOVAL WAS CONFIRMED NOT TO BE THROMBOSIS RELATED TO THE XIENCE PRIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283415 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2082741

    Patients

    Seq Age Sex Outcome Treatment
    1