BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2834016 · Received November 15, 2012

    Report

    Report Number
    2024168-2012-07197
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 22, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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): 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 ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE INFLATION DIFFICULTIES WERE ABLE TO BE CONFIRMED DUE TO A TEAR IN THE SHAFT. BASED ON A VISUAL AND FUNCTIONAL INSPECTION 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 REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. IT WAS REPORTED THE LESION WAS NOT PRE-DILATED PRIOR TO ADVANCING THE XIENCE STENT DELIVERY SYSTEM. IT SHOULD BE NOTED THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: PRE-DILATE THE LESION WITH A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER. IN THIS CASE, IT IS NOT LIKELY THAT THE FAILURE TO PRE-DILATE THE LESION CONTRIBUTED TO THE REPORTED DIFFICULTIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A LESION WITH NO TORTUOSITY OR CALCIFICATION IN THE LEFT ANTERIOR DESCENDING ARTERY, THE 2.5 X 15 MM XIENCE V STENT DELIVERY SYSTEM (SDS) WAS ADVANCED FOR DIRECT-STENTING. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. AN ATTEMPT WAS MADE TO INFLATE THE DEVICE WITH A NON-ABBOTT INFLATION DEVICE; HOWEVER, THE INFLATION DEVICE CONTINUED TO READ 0 ATMOSPHERES (ATM). THE INFLATION DEVICE WAS CHANGED; HOWEVER, THIS ONE ALSO READ 0 ATM. THE XIENCE V SDS WAS REMOVED WITHOUT ISSUE, AND A NEW XIENCE V WAS USED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. 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 2030141

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR