BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1951366 · Received January 6, 2011

    Report

    Report Number
    2024168-2011-00073
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 14, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    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. DILATATION CATHETER: SPRINTER; GUIDE WIRE: BMW; INFLATION: MEDTRONIC; GUIDE CATHETER: CORDIS THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF DISSECTION, AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU), IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. DISSECTIONS CAN BE INFLUENCED BY SEVERAL FACTORS INCLUDING, BUT NOT LIMITED TO, LESION CHARACTERISTICS, PROCEDURAL TECHNIQUE, AND DEVICE SIZE SELECTION. IT SHOULD BE NOTED THAT 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 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 A PATIENT WITH CORONARY ARTERY DISEASE UNDERWENT PERCUTANEOUS CORONARY ANGIOPLASTY OF THE MID LEFT CIRCUMFLEX ARTERY. THE LESION WAS PREDILATED WITH A 2.5 X 15 BALLOON AND ONE 3.0 X 28 MM XIENCE V STENT WAS DEPLOYED AT 14 ATMOSPHERES IN THE LESION, ACHIEVING GOOD FLOW. AFTER WITHDRAWING THE STENT DELIVERY SYSTEM THE PHYSICIAN OBSERVED A FLOW LIMITING DISSECTION PROXIMAL TO THE STENT. ANOTHER 3.0 X 12 MM XIENCE V WAS DEPLOYED TO COVER THE DISSECTION. THE END RESULT WAS GOOD TIMI III FLOW. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0060841

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention CONCOMITANT MEDICAL DEVICES