BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1962097 · Received January 17, 2011

    Report

    Report Number
    2024168-2011-00347
    Event Type
    Injury
    Date Received
    January 17, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 24, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED. THE REPORTED INTERSTITIAL LUNG DISEASE IS LISTED AS A KNOWN ADVERSE EVENT ASSOCIATED WITH ORAL ADMINISTRATION OF EVEROLIMUS IN THE XIENCE V INSTRUCTIONS FOR USE. HOWEVER, BASED ON CLINICAL RESEARCH CONSULTATION, THE INTERSTITIAL LUNG DISEASE, WHICH WAS TREATED WITH MEDICATIONS AND RESULTED IN HOSPITALIZATION, MAY BE RELATED TO OTHER FACTORS BESIDES THE XIENCE V STENT AND COULD POSSIBLY BE RELATED TO THE OVERALL HEALTH AND CONDITION OF THE PATIENT, AS THE PATIENT HAD A HISTORY OF TOBACCO SMOKING. IN THIS CASE, A CONCLUSIVE CAUSE FOR THE REPORTED INTERSTITIAL LUNG DISEASE CANNOT BE DETERMINED. FACTORS THAT CAN CONTRIBUTE TO DIFFICULTY DEPLOYING A STENT CAN INCLUDE, BUT ARE NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, LESION CHARACTERISTICS, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, LEAKS/RUPTURES, BALLOON FOLD QUALITY, STENT DAMAGE, INFLATION TECHNIQUE, PRODUCT SIZE SELECTION, AND/OR LESION SIZE. REPORTEDLY, THE 3.0 X 23MM XIENCE V STENT WAS IMPLANTED IN A BIFURCATION LESION. IT SHOULD BE NOTED THAT THE XIENCE V INSTRUCTIONS FOR USE STATES THAT: THE XIENCE V STENT IS CONTRAINDICATED FOR PATIENTS WITH BIFURCATION CORONARY VESSEL DISEASE. IN THIS CASE, IT IS POSSIBLE THAT THE MODERATELY TORTUOUS BIFURCATION LESION CONTRIBUTED TO THE REPORTED DIFFICULTY TO DEPLOY, ALTHOUGH THIS CANNOT BE CONFIRMED. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY TO DEPLOY CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ADDITIONALLY, THE REPORTED POST-DILATATION (ADDITIONAL THERAPY/NON-SURGICAL TREATMENT), WHICH WAS REQUIRED TO FULLY EXPAND THE STENT, APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. A CONCLUSIVE CAUSE CANNOT BE DETERMINED FOR THE INTERSTITIAL LUNG DISEASE, WHICH WAS TREATED WITH MEDICATIONS AND RESULTED IN HOSPITALIZATION, OR THE REPORTED DIFFICULTY TO DEPLOY. HOWEVER, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO A VISUAL INSPECTION. ADDITIONALLY, A SAMPLING OF UNITS FROM EVERY LOT IS DESTRUCTIVELY TESTED PRIOR TO RELEASE TO VERIFY STENT DEPLOYMENT DIMENSIONS, AS WELL AS STENT UNIFORMITY OF EXPANSION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE REMAINS IN THE PATIENT. THE LOT NUMBER WAS NOT PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION REPORTS THAT AFTER THE PATIENT EXHIBITED SYMPTOMS OF INTERSTITIAL LUNG DISEASE, PULSE STEROIDS WERE ADMINISTERED FOR THREE DAYS, 1G PER DAY. AS OF (B)(6) 2011, THE PATIENT IS IN STABLE CONDITION AND CONTINUES TO TAKE STEROIDS ORALLY WITH A WAIT-AND-SEE APPROACH. THE PATIENT WAS CONFIRMED TO BE IN THE HOSPITAL WITH DISCHARGE PENDING SOON. THE FOLLOWING MEDICATIONS WERE PRESCRIBED DAILY AFTER (B)(6) 2010: PREDNISOLONE 5MG 8TABLETS, PARIET 10MG 1 TABLET, BAKTAR 1 TABLET, BIASPIRIN 100MG 1 TABLET, PLAVIX 75ML 1 TABLET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, A 3.0X23 XIENCE V STENT WAS IMPLANTED AT THE BIRFURCATION OF THE LEFT ANTERIOR DESCENDING ARTERY AND THE 1ST DIAGONAL ARTERY. AFTER STENT DILATATION AT 16 ATMOSPHERES FOR 15 SECONDS, INTRAVASCULAR ULTRASOUND (IVUS) REVEALED THAT THE STENT WAS NOT FULLY DILATED. POST DILATATION WAS PERFORMED USING A NON-ABBOTT DILATATION CATHETER. IVUS CONFIRMED THAT THE STENT WAS FULLY DILATED AND THE PROCEDURE WAS COMPLETED. ON (B)(6) 2010 THE PATIENT EXHIBITED SYMPTOMS OF INTERSTITIAL LUNG DISEASE. THE PATIENT IS CURRENTLY TAKING PLAVIX, BIASPIRIN AND SIGMART. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0082541

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| O| R INTRAVASCULAR ULTRASOUND