BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA PZF NANOCOATED CORONARY STENT SYSTEM

    MDR report key: 6809198 · Received August 21, 2017

    Report

    Report Number
    3009306400-2017-00007
    Event Type
    Malfunction
    Date Received
    August 21, 2017
    Date of Event
    July 15, 2017
    Report Date
    August 21, 2017
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    PMA / PMN Number
    P160014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) ON (B)(6) 2017 FOR A TOTAL OCCLUSION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). MEDICAL AFFAIRS REVIEWED THE ANGIOGRAPHIC IMAGES. LESION WAS PENETRATED WITH THE GUIDEWIRE AND PRE-DILATED. AT THE FIRST DEPLOYED STENT, THERE WAS CAVING INSIDE THE STENT AFTER THE THIRD PROXIMAL PART OF THE BALLOON WHILE INFLATING (CALCIFIED AREA). THIS COULD SOMETIMES LEAD TO STRUTS PROTRUDING IN THE LUMEN THAT CAN INTERFERE WITH THE SECOND STENT PASSING THROUGH THE INITIAL STENT. HOWEVER, THE SECOND STENT SEEMS TO PASS THROUGH THE DISTAL PART OF THE FIRST STENT. THE IMAGES SHOW THE PHYSICIAN TRYING TO RETRIEVE THE 2ND STENT TO ALIGN ITS PROXIMAL EDGE TO THE DISTAL EDGE OF THE FIRST STENT BUT WAS NOT ABLE TO DEPLOY. AFTERWARDS, THE DISLODGED STENT APPEARED IN THE PROXIMAL PART OF THE FIRST STENT AND DEPLOYMENT WAS ACHIEVED WITH A SMALLER BALLOON. THE STENT WAS EXPANDED PROXIMALLY TO THE 1ST ONE WITH NO HARM TO THE PATIENT. BASED ON THE REVIEW OF DEVICE HISTORY RECORDS (LHR 07-0401-27524, LOT# 1501264002A), THE DEVICE MET ITS PREDETERMINED SPECIFICATIONS, INCLUDING STENT RETENTION TEST DURING LOT RELEASE OF FINISHED GOODS. THE INTERACTION WITH THE PREVIOUSLY DEPLOYED STENT AND ITS PROTRUDED STRUTS DUE TO CALCIFICATION IS MOST LIKELY THE CAUSE FOR THE DISLODGEMENT. THE COBRA PZF INSTRUCTIONS FOR USE (IFU) ALSO RECOMMENDS TO STENT LESIONS DISTAL TO PROXIMAL IN ORDER TO AVOID INTERACTION WITH PREVIOUSLY DEPLOYED STENTS.

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO THE RIGHT CORONARY ARTERY (RCA), ONE OF THE COBRA PZF STENT DISLODGED FROM BALLOON BUT WAS SUCCESSFULLY RETRIEVED. PATIENT HAD A SUCCESSFUL PCI TO RCA USING 3 STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587472 COBRA PZF NANOCOATED CORONARY STENT SYSTEM STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 170-01-27524 1501264002A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention