BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 8525349 · Received April 17, 2019

    Report

    Report Number
    2024168-2019-03046
    Event Type
    Injury
    Date Received
    April 17, 2019
    Date of Event
    March 26, 2019
    Report Date
    May 16, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL FILE NUMBER - (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED DEVICE DAMAGED BY ANOTHER WAS CONFIRMED THROUGH OBSERVATION. 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 SIMILAR INCIDENTS FROM THIS LOT. THE REPORTED PATIENT EFFECT OF ISCHEMIA IS LISTED IN THE XIENCE SIERRA, EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AS IT IS LIKELY THE STENT AND GUIDEWIRE INTERACTED DURING STENT DEPLOYMENT CAUSING THE GUIDE WIRE TO BE JAILED WITH THE STENT WHICH RESULTED IN THE REPORTED DEVICE DAMAGED BY ANOTHER WITH THE PATIENT EFFECT OF ISCHEMIA. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    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: TERUMO RUNTHROUGH HYPERCOAT, XTA, SION BLUE; GUIDE CATH: HYPERION 6F, FINECROSS GT. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MILDLY TORTUOUS, MODERATELY CALCIFIED, 99% STENOSED, PROXIMAL TO DISTAL LEFT CIRCUMFLEX (CX) CORONARY ARTERY INTERVENTION, A NON-ABBOTT GUIDE WIRE WAS POSITIONED IN THE OBTUSE MARGINAL (OM) ARTERY TO PROTECT THE ARTERY. A 2.5X23MM XIENCE SIERRA STENT WAS DEPLOYED IN THE CX ARTERY, JAILING THE OSTIUM OF THE OM ARTERY. DURING REMOVAL OF THE NON-ABBOTT GUIDE WIRE, RESISTANCE WAS MET, AND IT WAS NOTED THAT THE IMPLANTED SIERRA STENT WAS ON THE DISTAL PORTION OF THE GUIDE WIRE. THE STENT WAS EXPLANTED AND FULLY REMOVED FROM THE ANATOMY. AS THIS WAS OCCURRING, THE PATIENT EXPERIENCED SOME ISCHEMIC CHANGES. A NEW XIENCE SIERRA STENT WAS IMPLANTED, RESOLVING THE ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316876 XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8062541

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SEE H10 FOR CONCOMITANT MEDICAL DEVICES