BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2233241 · Received September 2, 2011

    Report

    Report Number
    2024168-2011-06130
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    July 27, 2011
    Report Date
    August 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. ALTHOUGH THE ANATOMICAL CONDITION WAS NOT REPORTED, THE FAILURE TO CROSS WAS LIKELY RELATED TO CIRCUMSTANCES OF THE PROCEDURE. ADDITIONALLY, AN INTERACTION WITH THE LESION/ANATOMY DURING THE ATTEMPT TO CROSS THE LESION MAY HAVE RESULTED IN DAMAGE TO THE STENT SUCH THAT THE STENT BECAME LOOSENED ON THE BALLOON. SUBSEQUENT INTERACTION WITH THE CALCIFIED LESION DURING RETRACTION WOULD HAVE THEN LED TO THE STENT DISLODGEMENT. SINCE THERE WAS NO DAMAGE NOTED TO THE STENT OR THE STENT DELIVERY SYSTEM (SDS) DURING THE INSPECTION PRIOR TO USE, THIS SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTY. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT, INDICATING ALL LOT RELEASE TESTING MET SPECIFICATION. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE WAS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. ALL SDS ARE INSPECTED FOR PROPER STENT PLACEMENT, STENT DAMAGE AND CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE FIRST DIAGONAL BRANCH ARTERY, THE XIENCE V NANO WAS BEING ADVANCED, BUT COULD NOT CROSS THE LESION. DURING REMOVAL OF THE SYSTEM, THE STENT DISLODGED OFF THE BALLOON AND EMBOLIZED IN THE RIGHT HYPOGASTRIC ARTERY NEAR THE FEMORAL ARTERY. THE FOLLOWING DAY, (B)(6) 2011, THE PATIENT WENT TO SURGERY WHERE THE STENT WAS EXPANDED IN THE ILIAC ARTERY BY THE VASCULAR SURGEON. THERE WAS NO INFORMATION PROVIDED ABOUT TREATMENT OF THE TARGET LESION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THE PATIENT WAS DISCHARGED ONE DAY LATER, (B)(6) 2011. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS 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 1022143

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention