BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA PZF

    MDR report key: 8330171 · Received February 12, 2019

    Report

    Report Number
    3009306400-2019-00005
    Event Type
    Malfunction
    Date Received
    February 12, 2019
    Date of Event
    January 17, 2019
    Report Date
    June 3, 2019
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    PMA / PMN Number
    P160014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6 METHOD CODING 4118 REPLACED WITH 3331 AND 4117. H6 RESULTS CODING 3233 REPLACED WITH 3221. H6 CONCLUSION CODING 11 REPLACED WITH 22 AND 4315. THE DEVICE WAS LOST IN TRANSIT AND HAS NOT BEEN ABLE TO BE LOCATED, TO DATE. IF THE DEVICE IS RECOVERED, IT WILL BE ANALYZED WITH RESULTS REPORTED TO FDA IN A FOLLOW-UP REPORT. A REVIEW OF THE LOT HISTORY RECORD (LHR) WAS PERFORMED. THERE WERE NO NON-CONFORMANCES. THE LOT CONFORMS TO ITS PREDETERMINED SPECIFICATIONS AND REQUIREMENTS, INCLUDING FOR CROSSING PROFILE AND STENT RETENTION. INABILITY TO CROSS AND DISLODGEMENT ARE CAPTURED IN THE RISK ASSESSMENT AS KNOWN POTENTIAL HAZARDS. WHILE THE INVESTIGATION DETERMINED THAT A DEFINITIVE CONCLUSIVE CAUSE IS NOT ABLE TO BE ASSIGNED TO THE REPORTED COMPLAINT, THE MOST LIKELY CAUSE OF THIS REPORTED EVENT MAY BE DUE TO RE-INSERTION OF THE DEVICE IN COMBINATION WITH CHALLENGING ANATOMY (VESSEL MORPHOLOGY). 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, DURING 2ND INSERTION OF A 3.5X15MM COBRA PZF NANOCOATED CORONARY STENT SYSTEM, AN ATTEMPT WAS MADE TO ADVANCE IT TO THE VESSEL, BUT THE ATTEMPT WAS UNSUCCESSFUL. DURING WITHDRAWAL, THE STENT CAME OFF OF THE DELIVERY BALLOON. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH MULTIPLE REQUESTS WERE MADE, NO ADDITIONAL INFORMATION WAS PROVIDED BY THE SITE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT ESTIMATED. DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH RELEVANT ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, A 3.5X15MM COBRA PZF NANOCOATED CORONARY STENT SYSTEM WAS UNABLE TO CROSS A LESION IN AN UNSPECIFIED VESSEL. DURING WITHDRAWAL, THE STENT DISLODGED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124985 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. NA 1710164001

    Patients

    Seq Age Sex Outcome Treatment
    1