BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2231649 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06085
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    July 17, 2011
    Report Date
    August 9, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA AND THROMBOSIS ARE LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING AND THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011, THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD #6, #7 PROXIMAL). THE VESSEL HAD NO TORTUOSITY, WAS HEAVILY CALCIFIED WITH A 90% STENOSIS. PREDILATATION WAS PERFORMED ALONG WITH THE USE OF A ROTABLATOR PRIOR TO STENTING. TWO XIENCE V STENTS WERE IMPLANTED IN THE PROXIMAL LAD, A 2.75X23 MM AND A 2.5X23 MM. ALTHOUGH THE STENTS WERE NOTED TO BE APPOSED TO THE VESSEL WALL, POST-DILATATION WAS PERFORMED WITH A HIGH-PRESSURE BALLOON; HOWEVER, DUE TO THE CALCIFICATION IN THE VESSEL, THE STENTS COULD NOT BE EXPANDED ANY FURTHER. AN ATTEMPT WAS MADE TO DELIVER AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER FOR POST STENTING EXAMINATION; HOWEVER, THE IVUS CATHETER FAILED TO CROSS. THE PATIENT WAS DISCHARGED ON (B)(6) 2011. ON (B)(6) 2011, THE PATIENT EXPERIENCED AN OPPRESSIVE FEELING IN THE CHEST, AND CONSULTED THE CARDIOVASCULAR DEPARTMENT. ECHO CARDIOGRAM RESULTS REVEALED ST SEGMENT ELEVATION; THEREFORE, CORONARY ANGIOGRAPHY WAS PERFORMED IN THE LAD AND THE MOST PROXIMAL STENT, THE 2.75X23 MM XIENCE V WAS CONFIRMED TO BE 100% OCCLUDED AND DIAGNOSED AS SUB ACUTE THROMBOSIS. PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED. THE LESION WAS DILATED WITH A NON-ABBOTT BALLOON CATHETER AND TIMI 3 FLOW WAS OBTAINED. THE PATIENT WAS DISCHARGED ON (B)(6) 2011, FULLY RECOVERED. 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 0112241

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R STENTS: XIENCE V 2.5X23