BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2001734 · Received February 25, 2011

    Report

    Report Number
    2024168-2011-01208
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 19, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 3.0 X 18 MM XIENCE V ((B)(4)), IS BEING FILED UNDER A SEPARATE MFR NUMBER. EVALUATION SUMMARY: EVALUATION OF THE RETURNED XIENCE V STENT DELIVERY SYSTEM (SDS) NOTED BLOOD AND DRIED CONTRAST VISIBLE ON THE SHAFT, BALLOON, AND STENT, CONSISTENT WITH PREPARATION AND HANDLING. THE STENT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS WITH NO DAMAGE NOTED. THERE WERE SEVERAL KINKS NOTED TO THE SDS, CONFIRMING THE REPORTED INFORMATION. THE STENT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT IS NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. THE PATIENT ANATOMY WAS REPORTEDLY HEAVILY TORTUOUS, WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. THE KINKS NOTED LIKELY OCCURRED DURING THE PROCEDURE, AS NO DAMAGE WAS REPORTED AS BEING NOTED DURING THE INSPECTION PRIOR TO USE. IT IS LIKELY THAT AS RESISTANCE WAS ENCOUNTERED DURING THE ATTEMPTS TO ADVANCE THE SDS IN THE TIGHT AND TORTUOUS LESION, MANIPULATION OF THE SDS LIKELY RESULTED IN THE SHAFT KINKING. ANALYSIS NOTED THE TIP WAS SEPARATED AT THE DISTAL EDGE OF THE DISTAL SEAL. THE SEPARATED PORTION WAS NOT RETURNED. THE FRACTURE FACE WAS JAGGED, WHICH SUGGESTS THAT THE SEPARATION MAY BE RELATED TO TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE TIP SEPARATION MAY HAVE OCCURRED DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. A CONCLUSIVE CAUSE FOR THE NOTED TIP DETACHMENT COULD NOT BE DETERMINED; HOWEVER, THE REPORTED FAILURE TO ADVANCE AND KINKS APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ADDITIONALLY, ALL STENT DELIVERY SYSTEMS ARE VISUALLY INSPECTED ONLINE FOR DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF A TORTUOUS, SEVERE TIGHT LESION OF A UNSPECIFIED VESSEL, SIGNIFICANT RESISTANCE WAS ENCOUNTERED DURING INSERTION AND THE XIENCE V COULD NOT CROSS THE LESION. IT WAS NOTED THAT CONTINUOUS DEVICE FLUSHING WAS MAINTAINED DURING THE PROCEDURE AND INTRAVASCULAR ULTRASOUND WAS USED. THE PHYSICIAN TRIED TO USE A SECOND 3.0 X 18 MM XIENCE V BUT THE DEVICE COULD NOT CROSS THE LESION. ONLY BALLOON ANGIOPLASTY WAS USED IN THE PROCEDURE. THERE WAS NO REPORTED PATIENT EFFECT. ONCE OUTSIDE THE ANATOMY, IT WAS NOTED THAT THE MID PARTS OF THE DEVICE WERE SLIGHTLY KINKED. THOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION PROVIDED. DEVICE EVALUATION REVEALED SOFT TIP SEPARATION. THE SEPARATED SOFT TIP WAS NOT RETURNED.

    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 9090341

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR STENT: 3.0 X 18 MM XIENCE V ((B)(4))