BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA PZF

    MDR report key: 7655704 · Received July 2, 2018

    Report

    Report Number
    3009306400-2018-00025
    Event Type
    Malfunction
    Date Received
    July 2, 2018
    Date of Event
    June 1, 2018
    Report Date
    September 13, 2018
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    PMA / PMN Number
    160014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE STENT REMAINS IMPLANTED IN THE PATIENT AND THE DELIVERY SYSTEM WAS NOT RETURNED. AS THE LOT NUMBER WAS NOT REPORTED, AS REVIEW OF THE LOT HISTORY RECORD WAS UNABLE TO BE CONDUCTED; HOWEVER, ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE. A RISK ASSESSMENT REVIEW CONFIRMED THAT THE REPORTED STENT DISLODGEMENT IS CAPTURED AS A FORESEEABLE EVENT. 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 · 0

    DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, A COBRA PZF NANOCOATED CORONARY STENT (SIZE UNSPECIFIED) STARTED TO DISLODGE BUT WAS ULTIMATELY ABLE TO BE DEPLOYED. THERE WAS NO REPORT OF ANY ADVERSE PATIENT EFFECTS. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS ESTIMATED. DATE OF IMPLANT ESTIMATED. THE STENT REMAINS IMPLANTED IN THE PATIENT AND THE DELIVERY SYSTEM WAS NOT RETURNED. AS THE LOT NUMBER WAS NOT REPORTED, AS REVIEW OF THE LOT HISTORY RECORD WAS UNABLE TO BE CONDUCTED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WITH ADDITIONAL RELEVANT INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, A COBRA PZF NANOCOATED CORONARY STENT (SIZE UNSPECIFIED) STARTED TO DISLODGE BUT WAS ULTIMATELY ABLE TO BE DEPLOYED. THERE WAS NO REPORT OF ANY ADVERSE PATIENT EFFECTS. ADDITIONAL INFORMATION WAS REQUESTED, BUT HAS NOT YET BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496499 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1