BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3143561 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03472
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 19, 2013
    Report Date
    May 20, 2013
    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. (B)(4): NO PRE-DILATATION. CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: RUNTHROUGH NS; GUIDE CATHETER: EBU 3.0, 6F. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF DISSECTION, AS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU), IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURE. IT SHOULD BE NOTED THE IFU STATES: PRE-DILATE THE LESION WITH A PTCA CATHETER. 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 THE PATIENT PRESENTED WITH ACUTE CORONARY SYNDROME AND 100% STENOSIS AT THE PROXIMAL SEGMENT OF THE NON-TORTUOUS, NON-CALCIFIED, LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN MADE THE DECISION TO PROCEED WITH ANGIOPLASTY. THROMBUS ASPIRATION WAS PERFORMED AND DIRECT STENTING WAS PERFORMED USING A RX XIENCE V 3.5X28 STENT SYSTEM. AFTER DEPLOYMENT OF THE STENT, A DISSECTION WAS OBSERVED AT THE DISTAL SEGMENT OF THE STENT. A XIENCE V 3.0X18 STENT WAS DEPLOYED TO SUCCESSFULLY COVER THE DISSECTION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245324 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2112941

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention