BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2760699 · Received September 26, 2012

    Report

    Report Number
    2024168-2012-06065
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    September 3, 2012
    Report Date
    September 5, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. GUIDE WIRE: BMW, INFLATION: MEDTRONIC, GUIDE CATH: CORDIS, SHEATH: CORDIS. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF DISSECTION IS A KNOWN OBSERVED AND POTENTIAL ADVERSE EVENT AS LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE. FURTHERMORE, THE STENT PLACEMENT - PRECAUTIONS SECTION OF THE IFU STATES: IMPLANTING A STENT MAY LEAD TO DISSECTION OF THE VESSEL DISTAL AND / OR PROXIMAL TO THE STENT, AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION (CABG, FURTHER DILATATION, PLACEMENT OF ADDITIONAL STENTS, OR OTHER). ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MILDLY CALCIFIED, MILDLY TORTUOUS, DE NOVO, 90% STENOSED, MID, LEFT ANTERIOR DESCENDING ARTERY (LAD) STENTING PROCEDURE, AFTER PRE-DILATATION WITH A TREK BALLOON, A XIENCE PRIME 3.0 X 15 MM STENT WAS IMPLANTED AND AN EDGE DISSECTION OCCURRED. ANOTHER XIENCE PRIME STENT WAS USED TO SUCCESSFULLY COVER THE DISSECTION. THE PATIENT ACHIEVED A GOOD TIMI FLOW. THERE WAS NO ADVERSE PATIENT SEQUELA OR NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 1062941

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention