BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2073104 · Received April 29, 2011

    Report

    Report Number
    2024168-2011-03016
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    February 11, 2011
    Report Date
    April 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE NOTED BLOOD VISIBLE ON THE DISTAL SHAFT AND CONTRAST IN THE INFLATION LUMEN, CONSISTENT WITH PREPARATION AND THE STENT DELIVERY SYSTEM (SDS) BEING ADVANCED INTO THE PATIENT ANATOMY. THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS WITH NO DAMAGE NOTED. THERE WAS NO SEPARATION NOTED TO THE SDS AS REPORTED. THERE WERE MULTIPLE KINKS AND BENDS IN THE HYPOTUBE 15 CM DISTAL TO THE STRAIN RELIEF TUBING FOR A LENGTH OF 35 CM. THE TIP LENGTH AND STENT OUTER DIAMETERS WERE MEASURE AND MET MANUFACTURING CRITERIA. IN THIS CASE, THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. THE PATIENT ANATOMY WAS HEAVILY CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. IT IS LIKELY THAT AS RESISTANCE WAS ENCOUNTERED, FORCE WAS APPLIED IN THE ATTEMPT TO ADVANCE THE SDS, RESULTING IN THE SHAFT KINKING AND BENDING. 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 THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY WITH HEAVY CALCIFICATION. AFTER PRE-DILATATION WAS PERFORMED, AN ATTEMPT WAS MADE TO ADVANCE THE XIENCE STENT DELIVERY SYSTEM; HOWEVER, THE DEVICE WOULD NOT CROSS DUE TO THE HEAVY CALCIFICATION, AND THE PROXIMAL SHAFT BROKE. THE SEPARATION OCCURRED OUTSIDE THE ANATOMY; THEREFORE, THE DEVICE WAS EASILY REMOVED FROM THE VESSEL. THE PROCEDURE WAS COMPLETED WITH TWO NON-ABBOTT STENTS AND SUCCESSFUL POST-DILATATION. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION REPORTED THAT THE HYPOTUBE WAS STILL INTACT (NOT SEPARATED).

    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 0110941

    Patients

    Seq Age Sex Outcome Treatment
    1