BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2882564 · Received December 20, 2012

    Report

    Report Number
    2024168-2012-08226
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    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. EVALUATION SUMMARY: GUIDE WIRE: WHISPER EXTRA SUPPORT, PILOT 50, GUIDE CATH: 6 FRENCH MEDTRONIC. THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SHAFT WAS CONFIRMED. THE REPORTED DIFFICULTY TO REMOVE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON 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 COULD 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 EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE XIENCE V STENT WAS ADVANCED AND DEPLOYED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITHOUT ISSUE. AFTER THE STENT WAS POST DILATED WITH THE STENT DELIVERY SYSTEM (SDS) AND THE SDS WAS FULLY DEFLATED, THERE WAS DIFFICULTY REMOVING THE XIENCE V SDS ONCE IT WAS INSIDE THE 6 FRENCH, NON-ABBOTT GUIDING CATHETER. THE SDS WAS SUCCESSFULLY REMOVED WITHOUT ADDITIONAL INTERVENTION AND IT WAS NOTED THAT THE DISTAL END OF THE SDS CATHETER WAS ACCORDIONED. THE SDS WAS REMOVED ON ITS OWN, WHILE THE WHISPER EXTRA SUPPORT GUIDEWIRE REMAINED IN THE LAD. IT DID NOT APPEAR TO BE AN ISSUE WITH THE WHISPER WIRE AS A PREDILATATION BALLOON HAD BEEN PREVIOUSLY LOADED AND REMOVED ON THIS WIRE WITHOUT ISSUE. AFTER THE XIENCE V SDS WAS REMOVED FROM THE WHISPER WIRE, THERE WERE NO OTHER DEVICES ADVANCED ON THAT WIRE. A PILOT 50 ALSO REMAINED IN THE LEFT CIRCUMFLEX CORONARY ARTERY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION 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 2082441

    Patients

    Seq Age Sex Outcome Treatment
    1