BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3482218 · Received November 21, 2013

    Report

    Report Number
    2024168-2013-07529
    Event Type
    Injury
    Date Received
    November 21, 2013
    Date of Event
    December 1, 2010
    Report Date
    November 12, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT ESTIMATED. DATE OF IMPLANT ESTIMATED. 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 EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY. IT SHOULD BE NOTED THAT DISSECTION, ISCHEMIA AND OCCLUSION ARE LISTED IN THE INSTRUCTIONS FOR USE AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED DISSECTION, OCCLUSION AND ISCHEMIA, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED AND A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY TO DEPLOY CAN NOT BE DETERMINED, THE ADDITIONAL THERAPY/ NON-SURGICAL TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE VISION STENTS REFERENCED ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW. IT WAS REPORTED THAT THIS WAS A SINGLE-CENTER RETROSPECTIVE STUDY TO EVALUATE THE ADDITIONAL VALUE OF STENTBOOST (SB), A MOTION-CORRECTED X-RAY TECHNIQUE THAT ENHANCES STENT VISUALIZATION, FOR THE ASSESSMENT OF STENT DEPLOYMENT AND PROCEDURE OPTIMIZATION DURING ROUTINE PERCUTANEOUS CORONARY INTERVENTIONS (PCI). WE RETROSPECTIVELY ANALYZED 260 CORONARY LESIONS TREATED BY STENT IMPLANTATION AND ASSESSED BY SB DURING 168 CONSECUTIVE PCI PROCEDURES (168 PATIENTS). A TOTAL OF 275 STENTS WERE IMPLANTED; 45% WERE DRUG ELUTING STENTS (DES) (INCLUDING XIENCE V). THE REMAINING STENTS WERE BARE METAL STENTS (INCLUDING VISION STENTS). DIRECT STENTING WAS PERFORMED IN 78%. RESULTS OF SB AND ANGIOGRAPHY WERE CONCORDANT FOR 210 LESIONS: 194 STENTS WERE CORRECTLY DEPLOYED (75%) AND 16 WERE UNDERDEPLOYED (6%), SHOWN BY BOTH TECHNIQUES. IN 47 PATIENTS (18%), SB DETECTED AN UNDERDEPLOYMENT OF THE STENT WHEREAS THE ANGIOGRAPHIC RESULT WAS GOOD. POSTDILATATION WAS PERFORMED ON THE BASIS OF SB IN 89% OF THESE CASES. A 29.7% DRUG ELUTING STENTS INSUFFICIENT STENT EXPANSION; 19.7% BARE METAL STENT INSUFFICIENT STENT EXPANSION. ADDITIONALLY, IN 3 CASES CORONARY ANGIOGRAPHY SHOWED A POOR RESULT OF PCI, DUE TO DISTAL CORONARY OCCLUSION IN 2 CASES AND DISTAL SLOW FLOW AND NONSTENOTIC DISSECTION IN THE LAST CASE REQUIRING EITHER STENT DEPLOYMENT OR BALLOON ANGIOPLASTY FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605456 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention