BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3173533 · Received June 17, 2013

    Report

    Report Number
    2024168-2013-03778
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MILDLY TORTUOUS, MODERATELY CALCIFIED, 90% STENOSED, MID RIGHT CORONARY ARTERY. PREDILATATION WAS PERFORMED WITH A TREK BALLOON PRIOR TO STENTING; HOWEVER, WHILE ADVANCING THE 2.75 X 12 MM XIENCE V STENT DELIVERY SYSTEM, HEAVY RESISTANCE WAS FELT AND THE SDS BECAME STUCK IN THE PROXIMAL SEGMENT OF THE LESION AND COULD NOT BE RETRACTED. FEARING A DISLODGEMENT OF THE STENT IMPLANT, THE DECISION WAS MADE TO PLACE THE STENT COVERING 60% OF THE LESION. PLAIN OLD BALLOON ANGIOPLASTY WAS PERFORMED ON THE REMAINING 40% OF THE LESION. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272954 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2042441

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention