BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 6065003 · Received October 28, 2016

    Report

    Report Number
    2024168-2016-07407
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    October 21, 2016
    Report Date
    October 28, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    UDI-DI
    08717648199578
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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. 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 IDENTIFIED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION. AFTER PLACING TWO UNSPECIFIED STENTS IN THE DISTAL AND MID LAD, A 3.5X38MM XIENCE ALPINE RX STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TOWARD THE TARGET LESION. AN UNSPECIFIED GUIDE CATHETER WAS NOTED TO BE SLIDING AND THE GUIDE CATHETER PUSHED THE SDS TOWARD THE ARTERY. THE SDS WAS QUICKLY PULLED BACK AND THE STENT DISLODGED DUE TO RESISTANCE WITH THE ANATOMY. THE STENT REMAINED ON THE GUIDE WIRE. THE SDS AND GUIDE CATHETER WERE WITHDRAWN FROM THE PATIENT ANATOMY AND AN 8 FRENCH GUIDE CATHETER WAS INSERTED. A SNARE WAS ADVANCED AND SUCCESSFULLY RETRIEVED THE STENT. THE GUIDE CATHETER, SNARED STENT AND GUIDE WIRE WERE WITHDRAWN AS A SINGLE UNIT FROM THE PATIENT ANATOMY. THE PHYSICIAN DECIDED NOT TO TREAT THE PROXIMAL LAD AND CONTINUED TO TREAT LESIONS IN OTHER VESSELS. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716539 XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 6012241 08717648199578

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention GUIDE CATH: EDU 4