BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2895607 · Received January 3, 2013

    Report

    Report Number
    2024168-2013-00055
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    November 5, 2012
    Report Date
    November 7, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETUNED FOR EVALUATION. STENT DAMAGE WAS CONFIRMED. DIFFICULT TO POSITION/GUIDING CATHETER RESISTANCE COULD NOT BE TESTED AS THIS INCIDENT WAS INITIALLY REPORTED AS A FAILURE TO ADVANCE/CROSS THE LESION, AND AS SUCH THE DEVICE WAS DISCARDED AFTER THE INITIAL ANALYSIS. BASED ON VISUAL 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. IT SHOULD BE NOTED THAT THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE INSTRUCTS THE PHYSICIAN TO: PRE-DILATE THE LESION WITH A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER. 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). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH REPORT, ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE REPORTED FAILURE TO CROSS DUE TO INTERACTION BETWEEN THE 2.5X23 XIENCE V RX STENT DELIVERY SYSTEM AND AN UNSPECIFIED GUIDING CATHETER WAS A NON-ABBOTT GUIDING CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE TO DIRECTLY STENT THE LESION (WITHOUT PRE-DILATATION PERFORMED), A 2.5X23 XIENCE V RX STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TOWARD AN 85% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY, HOWEVER, THOUGH NO FORCE WAS APPLIED, THE XIENCE SDS FAILED TO CROSS, REPORTEDLY, DUE TO INTERACTION BETWEEN THE XIENCE SDS AND AN UNSPECIFIED GUIDING CATHETER, AND THE DISTAL END OF THE STENT BECAME FLARED. THE XIENCE SDS WAS WITHDRAWN FROM THE GUIDING CATHETER WITH RESISTANCE FELT AND ANOTHER UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2943 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 1031441

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR GUIDING CATHETER: CORDIS