BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA PZF

    MDR report key: 7035450 · Received November 15, 2017

    Report

    Report Number
    3009306400-2017-00015
    Event Type
    Malfunction
    Date Received
    November 15, 2017
    Date of Event
    October 13, 2017
    Report Date
    November 15, 2017
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397000906
    PMA / PMN Number
    P160014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND THE STENT DISLODGEMENT WAS CONFIRMED. FAILURE TO ADVANCE WAS UNABLE TO BE REPLICATED IN A TESTING ENVIRONMENT DUE TO CLINICAL OPERATIONAL / PROCEDURAL FACTORS THAT CAN BE ATTRIBUTED TO ADVANCEMENT DIFFICULTIES. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT. BASED ON THE ANALYSIS OF THE STENT AND ITS DELIVERY SYSTEM, THE RETURNED DEVICE DID NOT SHOW ANY INDICATION OF DEVICE RELATED ISSUES OR DEVICE DEFICIENCY THAT COULD HAVE CAUSED THE REPORTED FAILURE TO ADVANCE AND STENT DISLODGEMENT. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE. A REVIEW OF THE LOT HISTORY RECORD INDICATED THAT THERE WERE NO NON-CONFORMANCES RELATED TO THE REPORTED DIFFICULTIES FOR THIS LOT. A RISK ASSESSMENT REVIEW CONFIRMED THAT THE REPORTED FAILURE TO ADVANCE AND STENT DISLODGEMENT ARE CAPTURED AS FORESEEABLE EVENTS. THE INVESTIGATION DETERMINED THAT WHILE A DEFINITIVE CONCLUSIVE CAUSE IS NOT ABLE TO BE ASSIGNED TO THE REPORTED COMPLAINT, THE REPORTED ADVANCEMENT DIFFICULTY AND STENT DISLODGEMENT APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING; THERE IS NO EVIDENCE OF A DEVICE DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2017, AFTER PRE-DILATING THE A MODERATELY CALCIFIED LESION IN THE PROXIMAL CIRCUMFLEX CORONARY ARTERY, A 4.0 X 12 MM COBRA PZF STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION. THE COBRA SDS WAS WITHDRAWN, AND ADDITIONAL PRE-DILATATION WAS PERFORMED. THE SAME COBRA SDS WAS RE-INSERTED, BUT UPON EXITING THE GUIDE CATHETER (EBU 3.5), IT WAS NOTED THAT THE STENT WAS NO LONGER ON THE BALLOON. ALL DEVICES WERE WITHDRAWN AS A SINGLE UNIT AND THE STENT CAME OUT ALONG WITH THE DEVICES; THE STENT HAD DISLODGED AT SOME POINT WHILE ENTERING PATIENT VASCULATURE. NO FORCE WAS APPLIED AT ANY TIME WHILE USING THE COBRA SDS. A 3.5 MM COBRA PZF SUCCESSFULLY CROSSED AND THE STENT WAS DEPLOYED. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812175 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 1703294001 00879397000906

    Patients

    Seq Age Sex Outcome Treatment
    1