BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3063351 · Received April 17, 2013

    Report

    Report Number
    2024168-2013-02353
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE BALLOON RUPTURE WAS ABLE TO BE CONFIRMED. BASED ON A VISUAL AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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 REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE CONCENTRIC, MILDLY TORTUOUS, NON-CALCIFIED PROXIMAL TO MID RIGHT CORONARY ARTERY, A 3.5X18 RX XIENCE PRIME STENT WAS DEPLOYED AT 8 ATMOSPHERES FOR TREATMENT OF A 90% DE NOVO LESION. AN ATTEMPT WAS MADE TO RE-INFLATE THE BALLOON IN THE PROXIMAL SEGMENT OF THE STENT AS STANDARD PROCEDURE (POST DILATATION) AND THE BALLOON RUPTURED AT 12 ATMOSPHERES. THE STENT SYSTEM WAS WITHDRAWN FROM THE ANATOMY WITH THE STENT EXPANDED SUFFICIENTLY. THE PROCEDURE WAS COMPLETED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE DEVICE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164391 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2040441

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATH: 5F, HEARTRAIL JL40. SION BLUE, VIEWIT