BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2880417 · Received December 19, 2012

    Report

    Report Number
    2024168-2012-08178
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THE NC TREK, REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MODERATELY TORTUOUS, HEAVILY CALCIFIED, CONCENTRIC, 90% STENOSED, DE NOVO, OBTUSE MARGINAL ARTERY STENTING PROCEDURE, AFTER PRE-DILATATION WITH A TREK BALLOON 2.0 X 12MM DILATATION CATHETER (BDC), A XIENCE PRIME STENT WAS IMPLANTED. REPORTEDLY, THE XIENCE PRIME STENT WAS NOT FULLY APPOSED TO THE VESSEL WALL AND A TREK 3.0 X 12MM BDC WAS ADVANCED FOR POST-DILATATION AND WITH THE FIRST INFLATION, THE BALLOON RUPTURED AT 12 ATMOSPHERES. THE TREK BDC WAS REMOVED AND ANOTHER NON-ABBOTT BDC WAS USED FOR POST-DILATATION TO FULLY APPOSE THE XIENCE PRIME TO THE VESSEL WALL COMPLETING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELA OR NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2082441

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention