BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 7070696 · Received November 30, 2017

    Report

    Report Number
    2024168-2017-09262
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    November 10, 2017
    Report Date
    November 30, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    UDI-DI
    08717648199554
    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. CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: RUNTHROUGH, GUIDE CATH: HYPERION. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AS IT IS LIKELY THE DEVICE INTERACTED WITH THE ANATOMY RESULTING IN THE REPORTED FAILURE TO ADVANCE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, ECCENTRIC AND HEAVILY CALCIFIED PROXIMAL LEFT CIRCUMFLEX ARTERY. AFTER PRE-DILATATION, AN ATTEMPT WAS MADE TO ADVANCE A 3.5 X 28 MM XIENCE ALPINE; HOWEVER, IT COULD NOT CROSS THE LESION DUE TO THE ANATOMY. THEREFORE, THE DEVICE WAS REMOVED FROM THE ANATOMY BUT AS IT WAS BEING REMOVED, THE STENT BECAME CAUGHT WITH THE TIP OF A NON-ABBOTT GUIDING CATHETER, WHICH CAUSED THE STENT STRUT TO BECOME FLARED. THE DEVICE WAS THEN REMOVED INDEPENDENTLY AND REPLACED WITH ANOTHER 3.5 X 28 MM XIENCE ALPINE STENT THAT ADVANCED THROUGH AN UNSPECIFIED GUIDELINER TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852725 XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 7060141 08717648199554

    Patients

    Seq Age Sex Outcome Treatment
    1