BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1172739 · Received September 22, 2008

    Report

    Report Number
    2024168-2008-00830
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 2, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - PRODUCT PERFORMANCE ENGINEERING COULD NOT DETERMINE A CONCLUSIVE ROOT CAUSE FOR THE STENT DISLODGEMENT. EVAL SUMMARY: QA ANALYSIS REVEALED THAT ONLY THE STENT IMPLANT WAS RETURNED. THERE WAS NO BLOOD OR CONTRAST VISIBLE ON THE STENT IMPLANT. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. THE PROTECTIVE SHEATH WAS NOT RETURNED. A SNAP GUAGE WAS USED TO MEASURE THE OUTER DIAMETERS OF THE STENT IMPLANT. THE MEASUREMENTS MET MFG CRITERIA. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO AND ANALYSIS OF THE RETURNED DEVICE. STENT RETENTION (DISLODGEMENT) DURING USE CAN BE INFLUENCED BY MANY FACTORS, INCLUDING, BUT NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, INCORRECT SHEATH SIZING, POSITIVE PRESSURE DURING PREPARATION FOR USE, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PREPARATION FOR USE, OR INTERACTION OF THE STENT WITH THE LESION AND/OR ACCESSORY DEVICES. TO HELP ENSURE THIS TYPE OF EVENT IS NOT THE RESULT OF A MFG ISSUE, ALL STENT DELIVERY SYSTEMS (SDS) ARE INSPECTED FOR PROPER STENT PLACEMENT, STENT DAMAGE AND CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, PRIOR TO LOT RELEASE, A SAMPLING OF UNITS ARE DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE AND THE UNITS ARE ALSO INSPECTED FOR STENT PLACEMENT, CRIMPED STENT OUTER DIAMETER, AND STENT DAMAGE. THE SDS AND THE USED GUIDE WIRE WERE NOT RETURNED WHICH MAY HAVE ADDED IN THE INVESTIGATION AND DETERMINATION OF A ROOT CAUSE. IT SHOULD BE NOTED THAT IT WAS REPORTED THAT FORCE WAS APPLIED AFTER DIFFICULTY LOADING THE SDS ONTO THE GUIDE WIRE WAS EXPERIENCED AND THE PRODUCT INSTRUCTIONS FOR USE (IFU), STATES: "IF UNUSUAL RESISTANCE IS FELT BEFORE THE STENT EXITS THE GUIDING CATHETER, DO NOT FORCE PASSAGE. RESISTANCE MAY INDICATE A PROBLEM AND THE USE OF EXCESSIVE FORCE MAY RESULT IN STENT DAMAGE OR DISLODGEMENT. MAINTAIN GUIDE WIRE PLACEMENT ACROSS THE LESION AND REMOVE THE DELIVERY SYSTEM AND GUIDING CATHETER AS A SINGLE UNIT. "A CONCLUSIVE ROOT CAUSE FOR THE REPORTED STENT DISLODGEMENT COULD NOT BE DETERMINED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: STENT DISLODGEMENT HAS CAUSED OR CONTRIBUTED TO PT INJURY PREVIOUSLY. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT THE STENT WAS DIFFICULT TO LOAD ONTO THE GUIDE WIRE AND IN AN ATTEMPT TO LOAD IT, FORCE WAS APPLIED. THE STENT THEN DISLODGED AND THE DEVICE WAS NOT USED ON THE PT. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8050961

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK