BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3073551 · Received April 23, 2013

    Report

    Report Number
    2024168-2013-02504
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 26, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING; 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. A 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. HYPERTENSION AND RENAL FAILURE ARE LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS OF 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL REPORT FILING, ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE RENAL FAILURE AND HYPERTENSION COULD HAVE BEEN DUE TO THE DELAY IN PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS CALCIFIED. THE 3.5 X 15 MM XIENCE PRIME STENT WAS UNABLE TO BE ADVANCED TO THE DESIRED LOCATION DUE TO CALCIFICATION; THEREFORE THE STENT WAS NOT DEPLOYED. NO OTHER DEVICES WERE ABLE TO CROSS THE LESION, ONLY THE GUIDE WIRE CROSSED. THE PATIENT DEVELOPED HYPERTENSION AND TRANSIENT ACUTE RENAL FAILURE FORTY-EIGHT HOURS LATER. NO ADVERSE PATIENT EFFECTS RELATED TO THE FAILURE TO CROSS WERE REPORTED; HOWEVER, A CLINICALLY SIGNIFICANT DELAY OF PROCEDURE WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173415 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2073141

    Patients

    Seq Age Sex Outcome Treatment
    1 Other