BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1960617 · Received January 13, 2011

    Report

    Report Number
    2024168-2011-00283
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    October 1, 2008
    Report Date
    December 17, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. DISSECTION IS A KNOWN ADVERSE EVENT AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. 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 VIA A TRIAL THAT THE PROCEDURE WAS STAGED, THE FIRST PROCEDURE TOOK PLACE ON (B)(6) 2008, DURING WHICH A XIENCE V STENT WAS PLACED IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITHOUT COMPLICATIONS. THE SECOND STAGE OF THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2008. PREDILATATION WAS PERFORMED PRIOR TO STENTING. AFTER DEPLOYMENT OF THE STENT IN THE MID RIGHT CORONARY ARTERY (RCA), A DISSECTION WAS NOTED PROXIMAL TO THE DEPLOYED STENT. THE DISSECTION WAS REPORTED TO HAVE SEALED ITSELF WITH SOME RESIDUAL EFFECTS. DATE OF DISCHARGE (B)(6) 2008. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS STAGED, THE FIRST PROCEDURE TOOK PLACE ON (B)(6) 2008 DURING WHICH A XIENCE V STENT WAS PLACED IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITHOUT COMPLICATIONS. THE SECOND STAGE OF THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2008. PREDILATATION WAS PERFORMED PRIOR TO STENTING. AFTER DEPLOYMENT OF THE STENT IN THE MID RIGHT CORONARY ARTERY (RCA), A DISSECTION WAS NOTED PROXIMAL TO THE DEPLOYED STENT. THE DISSECTION WAS REPORTED TO HAVE MOSTLY SEALED ITSELF WITH SOME RESIDUAL EFFECTS, THAT WERE BELIEVED BY THE PHYSICIAN TO RESOLVE WITH TIME. THE DATE OF THE DISCHARGE WAS (B)(6) 2008. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other