BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2212349 · Received August 15, 2011

    Report

    Report Number
    2024168-2011-05760
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: 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. THE LESION CONDITION WAS DESCRIBED AS 90% STENOSED, WHICH LIKELY CONTRIBUTED TO THE FAILURE TO CROSS. ANALYSIS OF THE RETURNED PRODUCT NOTED BLOOD IN THE GUIDE WIRE LUMEN AND CONTRAST IN THE INFLATION LUMEN, WHICH IS CONSISTENT WITH PREPARATION AND A GUIDE WIRE ADVANCED INTO THE LUMEN. DIMENSIONAL ANALYSIS NOTED THE TIP LENGTH MET MANUFACTURING CRITERIA. ALTHOUGH NOT REPORTED, THE STENT IMPLANT WAS DISLODGED AND NOT RETURNED. ATTEMPTS FOR FOLLOW-UP INFORMATION WERE MADE, ALTHOUGH NOTHING HAS BEEN PROVIDED. HOWEVER, THE BALLOON WAS TIGHTLY FOLDED WITH CRIMP MARKS BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. STENT DISLODGEMENT 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 PREP, NEGATIVE PRESSURE DURING SHEATH REMOVAL, FORCED SHEATH REMOVAL, HANDLING OF THE STENT DURING PREP, AND INTERACTION WITH THE LESION, ACCESSORY DEVICES, AND/OR PREVIOUSLY IMPLANTED STENTS. TO ENSURE THIS IS NOT THE RESULT OF A PRODUCT DEFICIENCY, ALL STENT DELIVERY SYSTEMS ARE INSPECTED FOR PROPER STENT PLACEMENT, STENT DAMAGE AND CRIMPED STENT OUTER DIAMETER. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED PRIOR TO RELEASE TO VERIFY STENT DISLODGEMENT FORCE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. THERE IS NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE FAILURE TO CROSS APPEARS TO BE RELATED TO OPERATIONAL CONTEXT. HOWEVER, BASED ON THE INFORMATION PROVIDED AND ANALYSIS OF THE RETURNED PRODUCT, A DEFINITIVE CAUSE OF THE STENT DISLODGMENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE DISTAL RIGHT CORONARY ARTERY AND THE POSTERIOR DESCENDING ARTERY WITH 90% STENOSIS, THE 2.25 X 28 XIENCE NANO STENT DELIVERY SYSTEM WAS ADVANCED BUT COULD NOT CROSS THE LESION. THE DELIVERY CATHETER WAS REMOVED FROM THE ANATOMY AND A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY TREAT THE LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS REVEALED THAT THE STENT WAS DISLODGED AND NOT RETURNED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING DISLODGEMENT OF THE STENT OTHER THAN THERE WERE NO ADVERSE PATIENT EFFECTS.

    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 1022842

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR