BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 8391989 · Received March 5, 2019

    Report

    Report Number
    2024168-2019-01695
    Event Type
    Malfunction
    Date Received
    March 5, 2019
    Date of Event
    February 9, 2019
    Report Date
    June 19, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE CODES: 1562 NOT LABELED 2976 NOT LABELED. INTERNAL FILE NUMBER - (B)(4). CORRECTION: LOT NUMBER UPDATED FROM 7112241 TO 7112941 CORRECTION: DEVICE CODE 1069 WAS REMOVED AND DEVICE CODES 1562 AND 2976 ADDED. EVALUATION SUMMARY: VISUAL AND DIMENSIONAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED DEVICE SEPARATION WAS CONFIRMED. THE REPORTED MATERIAL DEFORMATION WAS NOT CONFIRMED. THE FAILURE TO ADVANCE WAS UNABLE TO BE REPLICATED IN A TESTING ENVIRONMENT AS IT IS BASED ON OPERATIONAL CIRCUMSTANCES. 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 PROXIMAL SHAFT DETACHMENT AND FAILURE TO ADVANCE ARE DUE TO CIRCUMSTANCES OF THE PROCEDURE. A CONCLUSIVE CAUSE FOR THE REPORTED MATERIAL DEFORMATION CANNOT BE DETERMINED AS THERE WAS NO STENT DAMAGE NOTED DURING RETURN DEVICE ANALYSIS. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. CINE IMAGES WERE PROVIDED AND REVIEWED BY AN ABBOTT VASCULAR CLINICAL SPECIALIST WHO STATED: THE CORONARY ANGIOGRAMS REVEALED TRIPLE VESSEL DISEASE WITH CALCIFICATION SEEN IN ALL THREE CORONARY ARTERIES. THE ARTERY OF SPECIFIC INTEREST WAS THE RIGHT CORONARY ARTERY. IT WAS A RELATIVELY SMALL VESSEL IN CALIBER AND NON-DOMINANT. THE VESSEL WAS TORTUOUS, HAVING A 90-DEGREE BEND IN THE PROXIMAL PORTION OF THE VESSEL. AN INTERVENTIONAL GUIDE WIRE WAS ADVANCE TO THE DISTAL RCA. THERE APPEARS TO BE A VERY SMALL INTIMAL INTERRUPTION AT THE LOCATION OF THE 90-DEGREE BEND WHICH MAY HAVE OCCURRED WITH THE ATTEMPTED INSERTION OF THE FIRST STENT, ALTHOUGH THE INSERTION OF THE STENT WAS NOT DOCUMENTED ON THE CINE. THE DESCRIBED STENT FLARING MAY BE CONSISTENT WITH ATTEMPTING TO ADVANCE A STENT THROUGH A CALCIFIED VESSEL AT A 90 DEGREE BEND BUT THIS COULD NOT BE CONFIRM BY CINE ANGIOGRAM. FOLLOW-UP WITH THE SITE CONFIRMED THAT THE XIENCE XPEDITION DID NOT CAUSE OR CONTRIBUTE TO THE DISSECTION.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL REPORT, ADDITIONAL INFORMATION WAS RECEIVED. THE LESION WAS MODERATELY TORTUOUS AND THE DEVICE FAILED TO CROSS THE LESION DUE TO THE ANATOMY. THE PROXIMAL SHAFT SEPARATED DURING THE PROCEDURE DURING WITHDRAWAL OF THE DEVICE. THE STENT STRUTS WERE ALSO NOTED TO BE FLARED. THE CINE REVIEW REVEALED THAT A SMALL DISSECTION OCCURRED; HOWEVER, IT WAS REPORTED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE DISSECTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. IT IS UNKNOWN IF THE DEVICE IS RETURNING FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A TORTUOUS RIGHT CORONARY ARTERY THAT WAS 90% STENOSED. AN ATTEMPT WAS MADE TO ADVANCE A 2.5 X 23 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS); HOWEVER, THE DEVICE FAILED TO CROSS THE LESION. ADDITIONALLY, THE SHAFT WAS NOTED TO BE BROKEN. ANOTHER UNSPECIFIED STENT WAS IMPLANTED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184178 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 7112941

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR