BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3202837 · Received July 2, 2013

    Report

    Report Number
    2024168-2013-04153
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF PERFORATION IS LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A FEMORAL ARTERIAL ACCESS APPROACH DURING A PROCEDURE OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD), THE 3.0 X 38 MM XIENCE XPEDITION WAS IMPLANTED, HOWEVER, VESSEL PERFORATIONS OCCURRED AT EACH END OF THE STENT. TWO GRAFTMASTER (GM) STENTS WERE USED TO TREAT THE PERFORATIONS AT EACH END OF THE XIENCE XPEDITION STENT- ONE MID LAD AND ONE DISTAL LAD. THE GRAFTMASTERS WERE INFLATED AT 14 ATMOSPHERE (ATM) WITH A GOOD RESULT SEALING THE PERFORATION AREAS. IT WAS NOTED THAT ALTHOUGH USE OF THE GM ACHIEVED GOOD RESULTS THE EASE OF HANDLING WAS 'POOR'; THIS DID NOT CAUSE OR CONTRIBUTE TO ADDITIONAL COMPLICATIONS OR ANY ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO USE OF THE GM. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT AND THE PATIENT WAS REPORTED AS SUBSEQUENTLY DISCHARGED FROM THE HOSPITAL. 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
    302486 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2081741

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention