BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2973037 · Received February 21, 2013

    Report

    Report Number
    2024168-2013-01035
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. FAILURE TO ADVANCE/CROSS THE LESION COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. THE SHAFT KINK AND SEPARATION WERE CONFIRMED. 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4) - IMPROPER OR INCORRECT PROCEDURE OR METHOD: AGAINST RESISTANCE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 4.0 X 23 MM XIENCE V STENT WAS SELECTED TO TREAT A HEAVY TORTUOUS, CALCIFIED, AND DIFFUSE MID RIGHT CORONARY ARTERY 99% STENOSIS, HOWEVER, THE STENT COULD NOT CROSS THE LESION, EVEN WITH BALLOON PREDILATION AND BUDDY WIRE TECHNIQUE. THE PHYSICIAN FELT STRONG RESISTANCE WHEN ADVANCING THE DEVICE TO THE TORTUOUS SEGMENT. THE SHAFT KINKED INSIDE OF THE GUIDING CATHETER AND SEPARATED INTO TWO PIECES WHEN REMOVED FROM THE PATIENT ANATOMY. IT WAS REMOVED AS A SINGLE UNIT FROM THE PATIENT ANATOMY. A SECOND 4.0 X 23 MM XIENCE V STENT WAS USED TO CROSS THE LESION SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76828 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2032841

    Patients

    Seq Age Sex Outcome Treatment
    1