BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2173411 · Received July 23, 2011

    Report

    Report Number
    2024168-2011-05094
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 24, 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, SION BLUE. GUIDE CATH: BRITE TIP 6 FR JR4.0. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED CONTRAST IN THE INFLATION LUMEN AND IN THE LOOSELY FOLDED BALLOON, WHICH IS CONSISTENT WITH PREPARATION AND THE STENT DEPLOYED. A LONGITUDINAL RUPTURE WAS NOTED IN THE DISTAL TAPER EXTENDING PROXIMALLY FOR A LENGTH OF 1.1 CM, THUS CONFIRMING THE INCIDENT. BALLOON RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, INTERACTIONS WITH THE STENT OR OTHER DEVICES, PATIENT ANATOMY, A PREVIOUSLY IMPLANTED STENT, LESION CALCIFICATION AND TORTUOSITY, OR INSUFFICIENT PREPARATION PRIOR TO USE. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF A MANUFACTURING DEFICIENCY, ALL PRODUCTS ARE 100% LEAK TESTED ON LINE AND A SAMPLING OF UNITS ARE RUPTURE TESTED PRIOR TO RELEASE. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS DETERMINED THAT THE BALLOON FAILURE MAY POSSIBLY BE ATTRIBUTED TO EXPOSURE CONDITIONS OR A MATERIALS/PROCESSING DISCREPANCY. THERE WAS NO REPORT OF ANY LEAK OR DAMAGE TO THE CATHETER NOTED DURING PREPARATION FOR USE OR DEPLOYMENT OF THE STENT, WHICH WOULD SUGGEST THAT THE BALLOON WAS NOT DAMAGED PRIOR TO USE AND THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE. IN THIS INSTANCE, IT IS POSSIBLE THAT THE MULTIPLE INFLATIONS AND/OR MILDLY TORTUOUS/MODERATELY CALCIFIED LESION CONTRIBUTED TO THE REPORTED BALLOON RUPTURE. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THIS INCIDENT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS FOR BALLOON RUPTURE REPORTED FOR THIS LOT. ADDITIONALLY, ON-LINE TEST DATA FOR THIS LOT SHOWS ALL UNITS PASSED THE MANUFACTURING CRITERIA. THIS SUGGESTS THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. BASED ON THE INFORMATION RECEIVED WITH THIS INCIDENT, THE RETURNED PRODUCT AND SEM ANALYSIS, THE BALLOON RUPTURE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AND NOT A PRODUCT QUALITY DEFICIENCY. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE AND BALLOON INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED DISTAL RIGHT CORONARY ARTERY, PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT DILATATION CATHETER. A 2.75 X 23 XIENCE V STENT WAS IMPLANTED; HOWEVER, WHILE USING THE STENT BALLOON TO PERFORM POST-DILATATION, THE BALLOON RUPTURED AT 14 ATMOSPHERES. THE DEVICE WAS REMOVED, AND A NON-ABBOTT DILATATION CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY AND NO ADVERSE PATIENT EFFECTS. ALTHOUGH 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 9120342

    Patients

    Seq Age Sex Outcome Treatment
    1