BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2173635 · Received July 23, 2011

    Report

    Report Number
    2024168-2011-05100
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. 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: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH BLOOD AND CONTRAST IN THE BALLOON AND THE INFLATION LUMEN. BLOOD INSIDE THE INFLATION LUMEN IS CONSISTENT WITH THE REPORTED BALLOON RUPTURE OCCURRING INSIDE THE PATIENT, SUGGESTING THE BLOOD WAS DRAWN IN WHEN NEGATIVE PRESSURE WAS APPLIED DURING REMOVAL OF THE SDS. THE BALLOON WAS RETURNED LOOSELY FOLDED CONSISTENT WITH INFLATION DURING THE PROCEDURE. A STOPCOCK WAS RETURNED ATTACHED TO THE HUB. AN INDEFLATOR, FILLED WITH WATER, WAS USED TO PRESSURIZE THE BALLOON BELOW RATED BURST PRESSURE (RBP) AND FLUID WAS OBSERVED LEAKING FROM A PINHOLE IN THE BALLOON 1.5 MM DISTAL TO THE PROXIMAL SHOULDER. THERE WERE NO SCRATCHES VISIBLE. SCANNING ELECTRON MICROSCOPY ANALYSIS RESULTS INDICATED THAT THE BALLOON FAILURE MAY BE ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. THE PINHOLES AND LEAK WERE LOCATED ADJACENT TO STENT STRUT IMPRESSIONS. THIS SUGGESTS THE CRIMPED STENT MAY HAVE CONTRIBUTED TO THE BALLOON RUPTURE, ALTHOUGH A CONCLUSIVE CAUSE CANNOT BE DETERMINED. THE BALLOON RUPTURE WOULD RESULT IN THE INABILITY TO HOLD PRESSURE IN ORDER TO FULLY APPOSE THE STENT. AN AIR EMBOLUS MAY RESULT WITH A BALLOON RUPTURE IF THE SDS AND/OR INDEFLATOR ARE NOT FULLY PRIMED, INCLUDING PURGING ALL AIR FROM THE SYSTEMS. ANALYSIS ALSO NOTED MULTIPLE BENDS IN THE ENTIRE LENGTH OF THE HYPOTUBE. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE NOTED BENDS WERE NOT REPORTED AND MOST LIKELY RESULTED FROM HANDLING OF THE PRODUCT POST-PROCEDURE DURING PACKING FOR SHIPMENT BACK TO ABBOTT VASCULAR FOR INVESTIGATION. IN ADDITION TO MECHANICAL DAMAGE, THE CRIMPED STENT MAY HAVE CONTRIBUTED TO THE BALLOON RUPTURE, ALTHOUGH A CONCLUSIVE CAUSE COULD NOT BE DETERMINED. BALLOON RUPTURES CAN OCCUR AS A RESULT OF, BUT ARE NOT LIMITED TO, MANUFACTURING (SUCH AS DAMAGE TO THE BALLOON FROM THE STENT CRIMP PROCESS OR FROM DAMAGE TO THE BALLOON DURING THE PROCESSING OF THE BALLOON MATERIAL) OR FROM DAMAGE DURING USE OF THE PRODUCT. DURING USE THERE CAN BE AN INTERACTION BETWEEN THE BALLOON AND THE ANATOMY AND/OR ACCESSORY DEVICES, WHICH CAN DAMAGE OR WEAKEN THE BALLOON MATERIAL AND LEAD TO RUPTURE DURING INFLATION. ALL STENT DELIVERY SYSTEMS (SDS) ARE LEAK TESTED ON-LINE AND A SAMPLING OF UNITS FROM ALL CATHETER LOTS ARE RUPTURE TESTED PRIOR TO RELEASE FOR USE IN THE FINISHED GOOD LOT AND THEN AGAIN, ONCE THE FINISHED GOODS LOT IS COMPLETED, A SAMPLING OF UNITS ARE AGAIN RUPTURE TESTED PRIOR TO THE RELEASE OF THE FINISHED GOOD LOT. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND NO OTHER INCIDENTS HAVE BEEN REPORTED FOR BALLOON RUPTURE FOR THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE XIENCE V STENT DELIVERY SYSTEM (SDS) BALLOON WAS INFLATED TO 8 - 10 ATMOSPHERES AND WOULD NOT HOLD PRESSURE DUE TO A PINHOLE LEAK NOTED IN THE BALLOON. AIR ENTERED INTO THE PATIENTS POSTERIOR DESCENDING ARTERY CAUSING DISTAL AIR EMBOLUS, SLOW FLOW AND ST ELEVATION. THE PATIENT WAS TREATED WITH NITROGLYCERIN AND THE SYMPTOMS RESOLVED. THE STENT WAS NOT FULLY DEPLOYED IN THE ARTERY REQUIRING THE USE OF A HIGH PRESSURE POST DILATATION BALLOON FOR COMPLETE APPOSITION TO THE VESSEL WALL. THE PATIENT IS REPORTED TO BE FINE. THERE WAS NO REPORTED ISSUE WITH THE DEVICE DURING PREPARATION PRIOR TO USE. 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 0092941

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention