BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2974357 · Received February 22, 2013

    Report

    Report Number
    2024168-2013-01053
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 26, 2013
    Report Date
    January 29, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECT OF DISSECTION IS LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE SECOND UNKNOWN XIENCE XPEDITION MENTIONED IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS NOT PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PRE-DILATING A LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) WITH AN UNSPECIFIED BALLOON DILATATION CATHETER, WITH THE USE OF AN UNSPECIFIED BUDDY WIRE, AN UNSPECIFIED RX XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION IN THE LAD, THEN THE STENT WAS DEPLOYED, RESULTING IN A VESSEL DISSECTION AT THE DISTAL END OF THE STENT. THE XPEDITION SDS WAS WITHDRAWN FROM THE ANATOMY. TO TREAT THE DISSECTION, A NEW UNSPECIFIED XPEDITION SDS WAS THEN ADVANCED INTO A NON-ABBOTT GUIDING CATHETER, HOWEVER, RESISTANCE WAS FELT BETWEEN THE GUIDING CATHETER AND THE XPEDITION; THE PHYSICIAN INDICATED THAT, THE OUTER DIAMETER OF THE BALLOON MATERIAL AT THE DISTAL END SEEMED TO BE LARGER, OR BULKIER, THAN A XIENCE V RX DEVICE. THE XPEDITION WAS WITHDRAWN FROM THE GUIDING CATHETER AND A NON-ABBOTT SDS WAS ABLE TO BE ADVANCED AND TREAT THE DISSECTION SUCCESSFULLY. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE AND NO REPORT OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77767 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE CATHETER: GUIDELINER