BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2991566 · Received March 6, 2013

    Report

    Report Number
    2024168-2013-01295
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 12, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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: 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. SHAFT SEPARATION WAS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A LESION IN A CALCIFIED PROXIMAL CIRCUMFLEX WITH A 90 DEGREE TURN, A 3.5 X 8 RX XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED VIA DIRECT STENTING AND RESISTANCE WAS FELT WITH THE PATIENT ANATOMY WHILE TRYING TO MAKE THE 90 DEGREE TURN TO THE TARGET LESION. REPORTEDLY, FORCE WAS APPLIED TO THE SDS AND THE PROXIMAL SHAFT SEPARATED INTO TWO PIECES. THE DISTAL PORTION OF THE SDS WAS SIMPLY WITHDRAWN FROM THE PATIENT ANATOMY. REPORTEDLY, WHILE THE ABBOTT TERRITORY MANAGER WAS WATCHING THE FILMS OF THE PROCEDURE IT LOOKED AS THOUGH A SMALL DISSECTION OCCURRED; HOWEVER, THE PHYSICIAN DID NOT NOTE A DISSECTION IN THE CATH LAB REPORT. A 3.0 X 12 RX XIENCE XPEDITION SDS AND A 3.0 X 8 RX XIENCE XPEDITION SDS WERE BOTH ADVANCED AND IMPLANTED TO SUCCESSFULLY TREAT THE TARGET LESION. THERE WAS NO ADVERSE PATIENT SEQUELAE AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95322 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2102241

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other