BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA PZF

    MDR report key: 7864647 · Received September 11, 2018

    Report

    Report Number
    3009306400-2018-00028
    Event Type
    Malfunction
    Date Received
    September 11, 2018
    Date of Event
    June 21, 2018
    Report Date
    July 20, 2018
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397007400
    PMA / PMN Number
    160014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REQUESTS FOR THE DEVICE WERE MADE, WITH NO RESPONSES RECEIVED TO DATE. A REVIEW OF THE LOT HISTORY RECORD (LHR) CONFIRMED THAT THERE WERE NO NON-CONFORMANCES. THE DEVICES FROM THIS LOT CONFORM TO THEIR PREDETERMINED SPECIFICATIONS, INCLUDING FOR STENT RETENTION. A RISK ASSESSMENT REVIEW CONFIRMED THAT DISLODGEMENT IS CAPTURED AS A FORESEEABLE EVENT. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WITH RELEVANT ADDITIONAL INFORMATION WILL BE FILED. THIS REPORT WAS RESUBMITTED AS "INITIAL" ONLY PER FDA REQUEST. NOTE THAT CODES IN H6 THAT CHANGED BETWEEN THE ORIGINAL 2018 INITIAL SUBMISSION AND THIS RE-SUBMISSION WERE OMMITED. SEE ORIGINAL REPORT FOR CODES IN USE AT THE TIME.

    Description of Event or Problem · 0

    A 69-YEAR-OLD MALE PATIENT PRESENTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING THE PROCEDURE, THE STENT OF A 3.5X15MM COBRA PZF NANOCOATED STENT SYSTEM DISLODGED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708433 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 1704064001 00879397007400

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male