BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM

    MDR report key: 3132491 · Received May 29, 2013

    Report

    Report Number
    2024168-2013-03304
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. THE FAULTY/DAMAGED HUB WAS NOT CONFIRMED. THE RETURNED DEVICE ANALYSIS REVEALED THAT THE HYPOTUBE SHAFT WAS SEPARATED DISTAL TO THE STRAIN RELIEF TUBING. ADDITIONAL RETURN DEVICE ANALYSIS REVEALED THERE WAS CONTRAST IN THE INFLATION LUMEN AND IN THE BALLOON. THE STENT IMPLANT WAS NOT RETURNED. THE BALLOON HAD LOOSE FOLDS. THERE WERE CRIMP MARKS ON THE BALLOON WHERE THE STENT IMPLANT HAD BEEN BETWEEN THE MARKERS. ADDITIONAL REPORTED INFORMATION INDICATES THAT HOSPITAL STAFF DOES NOT KNOW WHEN THE SHAFT SEPARATED OR WHY THE STENT IMPLANT WAS NOT RETURNED. BASED ON VISUAL ANALYSIS 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 INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF THE 3.0 X 12 RX XIENCE PRO STENT SYSTEM, THE HUB APPEARED TO BE FAULTY (DAMAGED) WHEN ATTEMPTING TO ATTACH THE SYRINGE. THE SPECIFIC TYPE OF DAMAGE WAS NOT RELEASED BY THE SITE. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. A NEW SAME DEVICE WAS USED IN THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE DEVICE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS REVEALED THAT THE HYPOTUBE SHAFT WAS SEPARATED DISTAL TO STRAIN RELIEF TUBING. ADDITIONAL RETURN DEVICE ANALYSIS REVEALED THERE WAS CONTRAST IN THE INFLATION LUMEN AND IN THE BALLOON. THE STENT IMPLANT WAS NOT RETURNED. THE BALLOON HAD LOOSE FOLDS. THERE WERE CRIMP MARKS ON THE BALLOON WHERE THE STENT IMPLANT HAD BEEN BETWEEN THE MARKERS. ADDITIONAL REPORTED INFORMATION INDICATES THAT HOSPITAL STAFF DOES NOT KNOW WHEN THE SHAFT SEPARATED OR WHY THE STENT IMPLANT WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237389 XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2121741

    Patients

    Seq Age Sex Outcome Treatment
    1