BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4305983 · Received December 8, 2014

    Report

    Report Number
    2024168-2014-08011
    Event Type
    Malfunction
    Date Received
    December 8, 2014
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FOR DEFLATION ISSUE, DIFFICULT TO REMOVE OR PHYSICAL RESISTANCE FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    PME FORM NUMBER (B)(4) EXPERIENCE XIENCE PRIME (B)(6) 2012. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE MARGINAL ARTERY. THE 4.0X18MM XIENCE V STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND THE STENT IMPLANT WAS DEPLOYED; HOWEVER, AFTER STENT DEPLOYMENT THE SDS BALLOON WAS NOT FULLY DEFLATED. ATTEMPTS WERE MADE TO RE-INFLATE AND RE-DEFLATE THE SDS. THE SDS AND GUIDING CATHETER WERE REMOVED AS A SINGLE UNIT. ADDITIONALLY, IT WAS REPORTED ON A POST MARKET EVALUATION (PME) FORM THAT THE SDS WAS SIGNIFICANTLY WORSE FOR DELIVERABILITY, LESION CROSSING, AND WITHDRAWAL THAN THE COMPARATOR DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791516 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2032241

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATH: LAUNCHER