BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3181886 · Received June 21, 2013

    Report

    Report Number
    2024168-2013-03849
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 27, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - EXCESSIVE FORCE, NO PRE-DILATATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE SHAFT SEPARATION WAS CONFIRMED. THE FAILURE TO ADVANCE/CROSS COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON VISUAL AND DIMENSIONAL 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. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS 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 PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: PRE-DILATE THE LESION WITH A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER. ADDITIONALLY, THE IFU STATES: SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE DELIVERY SYSTEM POST-STENT IMPLANTATION, THE ENTIRE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT AND THAT APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND / OR DELIVERY SYSTEM COMPONENTS. IN THIS CASE, THE IFU DEVIATION(S) APPEAR TO HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MILDLY TORTUOUS MID RIGHT CORONARY ARTERY. A GUIDE WIRE WAS CROSSED OVER THE LESION WITH NO DIFFICULTIES FOR STRAIGHTENING OF THE VESSEL. PRE-DILATATION OF THE LESION WAS NOT PERFORMED. AN ATTEMPT WAS MADE TO ADVANCE THE 3.5X12 MM XIENCE PRIME STENT DELIVERY SYSTEM; HOWEVER, IT WOULD NOT CROSS THE LESION. FORCE WAS APPLIED, WHICH RESULTED IN A HYPOTUBE SEPARATION, WHICH WAS ABLE TO BE REMOVED FROM THE ANATOMY WITHOUT ISSUE. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282014 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2041841

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR GUIDE WIRE: 0.014 GUIDE CATH: 6F XB4