BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2141354 · Received June 27, 2011

    Report

    Report Number
    2024168-2011-04495
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. GUIDE WIRE: RUNTHROUGH. GUIDE CATH: LAUNCHER 6 F JR4.0. ANALYSIS OF THE RETURNED PRODUCT NOTED CONTRAST VISIBLE IN THE INFLATION LUMEN AND IN THE LOOSELY FOLDED BALLOON, CONSISTENT WITH PREPARATION AND USE OF THE PRODUCT. THERE WERE TWO BENDS IN THE HYPOTUBE 41CM AND 94CM DISTAL TO THE STRAIN RELIEF TUBING. THE INFLATION DEVICE USED DURING THE PROCEDURE WAS RETURNED ATTACHED TO THE SDS HUB. THERE WAS A STOPCOCK ATTACHED TO THE INFLATION DEVICE. THERE WAS CONTRAST IN THE SYRINGE. FACTORS THAT MAY CONTRIBUTE TO THE DIFFICULTY TO DEFLATE A SDS INCLUDE, BUT ARE NOT LIMITED TO, UNEVENLY TRIMMED HYPOTUBE JACKET MATERIAL IN THE INFLATION PORT (HUB) CAUSING A VALVE WHEN INFLATED OR DEFLATED THUS BLOCKING THE FLOW OF CONTRAST, DEFLATION TECHNIQUE, CONTRAST CONCENTRATION, TORTUOUS ANATOMY, LOOSE CONNECTION WITH THE INDEFLATOR, CONTAMINATION IN THE INFLATION LUMEN OR DAMAGE TO THE GUIDE WIRE AND/OR INFLATION LUMEN. TO ENSURE THESE DIFFICULTIES ARE NOT THE RESULT OF MANUFACTURING, ALL PRODUCTS ARE 100% INSPECTED FOR PROPER BALLOON FOLD CONFIGURATION AND DAMAGE ONLINE, AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED FOR PROPER BALLOON DEFLATION. THE ENTIRE LENGTH OF THE SDS WAS MEASURED AND MET MANUFACTURING. THE RETURNED INFLATION DEVICE, FILLED WITH GASTROGRAFIN DILUTED 1:1 WITH WATER, WAS USED TO INFLATE THE BALLOON TO THE RATED BURST PRESSURE (RBP) AND THE DEFLATION TIMES WERE MEASURED AND DID NOT MEET MANUFACTURING CRITERIA AS THEY WERE ABOVE THE SPECIFICATION. AFTER THE INFLATION LUMEN WAS FLUSHED WITH WATER TO DISSOLVE ANY RESIDUAL CONTRAST, THE DEFLATION TIMES WERE MEASURED AGAIN AND MET MANUFACTURING CRITERIA. IT IS LIKELY THAT THE CONTRAST MIX RATIO MAY HAVE BEEN IMPROPERLY DILUTED AND COULD HAVE CONTRIBUTED TO THE DEFLATION DIFFICULTIES. CONTRAST THAT IS MORE CONCENTRATED CAN LEAD TO SLOWER DEFLATION. IT IS SPECIFIED IN THE INSTRUCTIONS FOR USE, MATERIALS REQUIRED SECTION, THAT THE CONTRAST IS 60% CONTRAST DILUTED 1:1 WITH NORMAL SALINE. ADDITIONALLY, THE NOTED BENDS IN THE HYPOTUBE LIKELY OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS AND DO NOT APPEAR TO HAVE CONTRIBUTED TO THE REPORTED DEFLATION DIFFICULTIES. 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. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR DEFLATION DIFFICULTIES FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. IN THIS CASE, THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE IN THE MILDLY TORTUOUS RIGHT CORONARY ARTERY, PRE-DILATATION WAS PERFORMED. A 3.0X23 XIENCE V STENT SYSTEM WAS ADVANCED AND THE STENT WAS SUCCESSFULLY DEPLOYED. THE PHYSICIAN WAS ABLE TO DEFLATE THE BALLOON COMPLETELY, BUT BALLOON DEFLATION TOOK LONGER THAN NORMAL. THE PHYSICIAN IMPLANTED A SECOND XIENCE V PROXIMAL TO THE FIRST STENT SUCCESSFULLY. INTRAVASCULAR ULTRASOUND WAS PERFORMED TO CONFIRM THE STENTS WERE WELL EXPANDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED SIGNIFICANT CLINICAL DELAY. 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 1011141

    Patients

    Seq Age Sex Outcome Treatment
    1