BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3133237 · Received May 29, 2013

    Report

    Report Number
    2024168-2013-03303
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 3, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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. (B)(4). 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): CONTRAST INCORRECT. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. INFLATION FAILURE WAS CONFIRMED DUE TO CRYSTALIZED CONTRAST IN THE INFLATION LUMEN THAT COULD NOT BE DILUTED DESPITE MULTIPLE ATTEMPTS. BASED ON VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT SHOULD BE NOTED THAT THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE STATES THAT THE CONTRAST DILUTION SHOULD BE 60% CONTRAST DILUTED 1:1 WITH NORMAL SALINE. BASED ON THE ANALYSIS OF THE DEVICE, NO DAMAGE OR LEAK HAS BEEN NOTED ON THE RETURNED DEVICE; THEREFORE, IT IS MOST LIKELY LIKE THAT THE CONTRAST WAS NOT MIXED AS REQUIRED PER THE IFU, WHICH CRYSTALIZED IN THE INFLATION LUMEN CAUSING THE REPORTED FAILURE TO INFLATE. ADDITIONALLY, IT WAS REPORTED THAT THE LESION WAS NOT PRE-DILATED PRIOR TO ADVANCEMENT OF THE DEVICE. ALTHOUGH DIRECT-STENTING (NO PRE-DILATION) DOES NOT APPEAR TO HAVE CONTRIBUTED TO THIS COMPLAINT, IT SHOULD BE NOTED THAT THE IFU INSTRUCTS THE PHYSICIAN TO PRE-DILATE THE LESION WITH A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NARROW LESION IN THE DIAGONAL VESSEL. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED AND THE 2.25 X 15 MM XIENCE V STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION FOR DIRECT STENTING AND INFLATED TO 10 ATMOSPHERES (ATM), BUT THE BALLOON COULD NOT BE INFLATED ANY LONGER. IT WAS CONFIRMED THAT THE STENT WAS SUCCESSFULLY DEPLOYED WITH THE SDS BALLOON. A NON-ABBOTT BALLOON CATHETER WAS USED FOR POST DILATATION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE RATIO/MIX OF CONTRAST USED DURING THE PROCEDURE WAS APPROXIMATELY 1:1.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236945 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2100841

    Patients

    Seq Age Sex Outcome Treatment
    1