BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2131619 · Received June 16, 2011

    Report

    Report Number
    2024168-2011-04260
    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 (B)(6) 2011, 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)