BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3073467 · Received April 23, 2013

    Report

    Report Number
    2024168-2013-02501
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    January 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. DATE OF EVENT ESTIMATED AS DATE OF PUBLICATION (B)(6) 2013. DATE OF IMPLANT ESTIMATED AS (B)(6) 2012. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE IF ANY CANNOT BE DETERMINED, RESTENOSIS IS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE, AS A KNOWN ADVERSE EVENT OF CORONARY STENTING PROCEDURES. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE ADDITIONAL EVENTS OF DEATH AND SERIOUS INJURY MENTIONED WILL BE FILED UNDER SEPARATE MFR NUMBERS.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW OF THE ARTICLE: COMPARISON OF DOUBLE KISSING CRUSH VERSUS CULOTTE STENTING FOR UNPROTECTED DISTAL LEFT MAIN BIFURCATION LESIONS: RESULTS FROM A MULTICENTER, RANDOMIZED, PROSPECTIVE DKCRUSH-III STUDY. THE STUDY AIMED TO INVESTIGATE THE DIFFERENCE IN MAJOR ADVERSE CARDIAC EVENT (MACE) AT 1-YEAR AFTER DOUBLE KISSING (DK) CRUSH VERSUS CULOTTE STENTING FOR UNPROTECTED LEFT MAIN CORONARY ARTERY (UPLMCA) DISTAL BIFURCATION LESIONS. THERE WERE A TOTAL OF 419 PATIENTS. THE XIENCE V STENT WERE ONE OF THE STENTS CHOSEN FOR THESE PROCEDURES. CLINICAL OUTCOMES WERE AS FOLLOWS: IN HOSPITAL: CARDIAC DEATH, 1.0%; MI: 7.1%. AT ONE MONTH FOLLOW-UP: CARDIAC DEATH, 1.0 %; MYOCARDIAL INFARCTION (MI), 7.6%; TOTAL LESION REVASCULARIZATION (TLR), 0.5%; TARGET VESSEL REVASCULARIZATION (TVR), 0.5%; STENT THROMBOSIS (ST), 0.5%. AT 12 MONTH FOLLOW-UP: CARDIAC DEATH, 2.0%; MI, 8.6%; TLR, 9.1%; TVR, 22.6%; CORONARY ARTERY BYPASS SURGERY, 1.0%; ST, 1.5%. IT WAS NOTED THAT INTRAVASCULAR ULTRASOUND FINDINGS REPORTED THAT A METALLIC RIDGE IS USUALLY SEEN AT THE OSTIAL SIDE BRANCH AFTER CULOTTE STENTING, LEADING TO THE FAILURE TO FULLY COVER THE OSTIAL SIDE BRANCH, AND RESULTING IN INCREASED IN-STENT RESTENOSIS AND TLR. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175219 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R