BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2920367 · Received January 17, 2013

    Report

    Report Number
    2024168-2013-00320
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IT IS LIKELY THAT ANY DAMAGE (FRACTURE-SEPARATION) NOTED TO THE DEPLOYED STENT IMPLANT OCCURRED AS A RESULT OF INTERACTIONS WITH THE LESIONS SUCH AS FATIGUE FROM CARDIAC DYNAMICS AND MOTION; HOWEVER, THIS CANNOT BE CONFIRMED. 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. THE REPORTED PATIENT EFFECT OF ANGINA IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE EVENT OF CORONARY STENTING PROCEDURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 3.5X23 MM XIENCE V STENT WAS IMPLANTED IN A HEAVILY TORTUOUS, DISTAL LEFT ANTERIOR DESCENDING ARTERY ON (B)(6) 2012. ON (B)(6) 2013, THE PATIENT WAS EXPERIENCING ANGINA. ANGIOGRAPHY WAS PERFORMED AND THE STENT IMPLANT WAS OBSERVED TO BE FRACTURED INTO TWO PIECES. A 3.5X23 MM XIENCE V STENT WAS PLACED IN THE SAME LESION, INSIDE THE FRACTURED STENT FOR SUCCESSFUL TREATMENT OF THE FRACTURED STENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26031 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0101241

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R