BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2131616 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04259
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA AND RE-STENOSIS ARE LISTED IN THE INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. 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 AND THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THE OTHER TWO XIENCE V STENTS ARE BEING REPORTED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 4 YEARS POST IMPLANTATION OF THREE XIENCE V STENTS IN THE DISTAL TO MID RIGHT CORONARY ARTERY (D-MRCA), THE PATIENT EXPERIENCED CHEST PAIN AND SHORTNESS OF BREATH DUE TO IN-STENT RESTENOSIS OF THE MRCA AND DRCA. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR BALLOON ANGIOPLASTY AND PLACEMENT OF A NON-ABBOTT STENT TO THE RESTENOSED STENTS. ALSO, A NEW LESION IN THE POSTERIOR DESCENDING ARTERY WAS TREATED. THERE WAS NO ADVERSE PATIENT SEQUELA AND ON 1/21/11, THE PATIENT WAS DISCHARGED. ALTHOUGH REQUESTED, THERE WAS NO ADDITIONAL INFORMATION 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 60601P1

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R STENT: XIENCE V STENTS(X2)