BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1902736 · Received November 18, 2010

    Report

    Report Number
    2024168-2010-02458
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 26, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE IMPLANTED IS AN ESTIMATION. THE STENT REMAINS IN THE PATIENT. FACTORS THAT CAN CONTRIBUTE TO THE STENT NOT BEING FULLY APPOSED TO THE VESSEL WALL INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, INFLATION TECHNIQUE DURING USE OF THE PRODUCT, AN INTERACTION WITH THE PATIENT ANATOMY AND/OR PREVIOUSLY IMPLANTED STENTS, POST DILATATION TECHNIQUE, OR UNDERSIZING OF THE VESSEL. TO ENSURE THIS TYPE OF OCCURRENCE IS NOT RELATED TO A POTENTIAL MANUFACTURING OR PRODUCT DEFICIENCY, ALL SDS ARE CONFIRMED BY VARIOUS QUALITY CHECKS TO VERIFY VISUAL, FUNCTIONAL AND DIMENSIONAL SPECIFICATIONS, INCLUDING PROPER BALLOON DIMENSIONS, AND PROPER STENT PLACEMENT. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY PROPER INFLATION AND STENT DEPLOYMENT. IN THIS CASE, THE STENT DELIVERY SYSTEM (SDS) WAS NOT RETURNED FOR ANALYSIS WHICH MAY HAVE ASSISTED THE EVALUATION. THERE WAS NO NOTE OF ANY DAMAGE TO THE SDS OR STENT IMPLANT OBSERVED PRIOR TO THE PROCEDURE, WHICH MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTIES EXPERIENCED. HOWEVER, IT WAS REPORTED THE LESION WAS MODERATELY CALCIFIED, WHICH COULD HAVE CONTRIBUTED TO THE STENT NOT BEING ABLE TO FULLY APPOSE TO THE VESSEL WALL. A VOYAGER NC BALLOON WAS ADVANCED TO THE STENT IN AN ATTEMPT TO BETTER APPOSE THE STENT TO THE VESSEL WALL, HOWEVER, THIS WAS UNSUCCESSFUL. IT WAS REPORTED THAT IVUS WAS PERFORMED AND 1 MM ANEURYSMS ON BOTH EDGES OF THE STENT WERE NOTED, WITH 30-40% IN-STENT RESTENOSIS. IT SHOULD BE NOTED THAT ANEURYSM AND RESTENOSIS ARE KNOWN ADVERSE EVENTS OF CORONARY STENTING AS LISTED IN THE INSTRUCTIONS FOR USE. IN THIS CASE, A CONCLUSIVE CAUSE CANNOT BE DETERMINED FOR THE REPORTED DIFFICULTY TO DEPLOY, ANEURYSM AND RESTENOSIS. HOWEVER, THE ADDITIONAL THERAPY/NON-SURGICAL TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PRODUCT AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 7 MONTHS POST XIENCE V STENT IMPLANTATION IN THE DISTAL RIGHT CORONARY ARTERY (DRCA), PER INTRAVASCULAR ULTRASOUND (IVUS), THE XIENCE V STENT WAS NOTED TO BE POORLY APPOSED TO THE VESSEL WALL WITH APPROXIMATELY 1MM ANEURYSMS ON BOTH EDGES OF THE STENT AND 30-40% IN-STENT RESTENOSIS. IVUS WAS NOT DONE DURING INITIAL STENT IMPLANTATION, SO IT IS UNKNOWN IF THE STENT PROPERLY APPOSED THE WALL AT THAT TIME. A VOYAGER NC BALLOON WAS UNSUCCESSFULLY TAKEN TO THE STENT IN AN ATTEMPT TO BETTER APPOSE THE STENT TO THE VESSEL WALL. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION 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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R