BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3090816 · Received May 2, 2013

    Report

    Report Number
    2024168-2013-02731
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 8, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE RETURNED DEVICE ANALYSIS INDICATED THAT THE STENT IMPLANT WAS TIGHTLY CRIMPED ON THE BALLOON, INDICATING THAT IT HAD NOT BEEN INFLATED AND USED IN A PATIENT. SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS REVEALED A TEAR IN THE INNER MEMBER 13.9 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH. A REVIEW OF THE COMPLAINT HANDLING DATABASE INDICATED NO SIMILAR COMPLAINTS REPORTED FOR THIS LOT. A REVIEW OF THE ELECTRONIC LOT HISTORY RECORD (ELHR) FOR THE REPORTED LOT REVEALED NO ASSOCIATED NONCONFORMING MATERIAL RECORDS (NCMRS), INDICATING ALL LOT RELEASE TESTING MET ACCEPTANCE SPECIFICATIONS. BASED ON A REVIEW OF RELATED RECORDS AND EVALUATION OF THE RETURNED DEVICE, THE MANUFACTURING GROUP CONCLUDED THAT THERE IS NO PRODUCT QUALITY DEFICIENCY; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION, A 3.0 X 12 MM XIENCE XPEDITION KEPT PULLING AIR. THE DEVICE WAS NOT USED. A NEW XIENCE XPEDITION WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191406 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2092842

    Patients

    Seq Age Sex Outcome Treatment
    1