BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBRA PZF

    MDR report key: 10756110 · Received October 29, 2020

    Report

    Report Number
    3009306400-2020-00027
    Event Type
    Injury
    Date Received
    October 29, 2020
    Date of Event
    September 30, 2020
    Report Date
    December 21, 2020
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    PMA / PMN Number
    P160014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H6 CODING REVISED. HEALTH IMPACT CODE REMAINS 4614 (WE WERE UNABLE TO ENTER THIS CODE IN H6 SECTION). STENT REMAINS IMPLANTED IN PATIENT AND THERE WAS NO REPORTED DELIVERY SYSTEM MALFUNCTION; THUS, THE DELIVERY SYSTEM IS PRESUMED DISCARDED AND WAS NOT REQUESTED. AS THE LOT NUMBER WAS NOT PROVIDED BY THE SITE, A REVIEW THE LOT HISTORY RECORD (LHR) WAS UNABLE TO BE PERFORMED. A RISK ASSESSMENT REVIEW INDICATES THAT THROMBOSIS IS CAPTURED AS A FORESEEABLE EVENT. A REVIEW OF INSTRUCTIONS FOR USE (IFU) WAS CONDUCTED. THROMBOSIS IS LABELED IN THIS IFU AS A POTENTIAL ADVERSE EVENT. CAUSES OF STENT THROMBOSIS CAN BE MULTI-FACTORIAL AND CAN INCLUDE PATIENT MEDICAL HISTORY AND COMORBIDITIES; NOT RESPONSIVE TO (OR COMPLIANT WITH) PRESCRIBED ANTIPLATELET THERAPY; VESSEL MORPHOLOGY; THROMBOGENIC VESSELS; INCREASE IN STENT SURFACE REACTIVITY; STENT THROMBOGENIC FOR PATIENT; STENT HEATED EXCESSIVELY BY MAGNETIC FIELD; STENT EXPANDED BEYOND DESIGN INTENT; STENT OVERSTRESSED LEADING TO FRACTURE, STENT IS UNDER UNDER-EXPANDED. IN THIS CASE, A ROOT CAUSE FOR THE STENT THROMBOSIS WAS UNABLE TO BE DETERMINED. 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

    ON AN UNSPECIFIED DATE, A PATIENT UNDERWENT PLANNED PERCUTANEOUS CORONARY INTERVENTION (PCI) VIA DEPLOYMENT OF COBRA PZF¿ (SIZE UNKNOWN) STENT IN AN UNSPECIFIED VESSEL. ON 30 SEP 2020, IT WAS REPORTED TO CELONOVA BIOSCIENCES THAT ON AN UNSPECIFIED DATE, THE PATIENT PRESENTED WITH POSSIBLE STENT THROMBOSIS. THOUGH MULTIPLE REQUESTS FOR INFORMATION WERE MADE, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    ESTIMATED DATE OF EVENT: (B)(6) 2020. ESTIMATED DATE OF IMPLANTATION: (B)(6) 2020. REPORTER IS NOT THE USER OF DEVICE. USER IS UNKNOWN AT THIS TIME. (B)(4). STENT REMAINS IMPLANTED IN PATIENT AND THERE WAS NO REPORTED DELIVERY SYSTEM MALFUNCTION; THUS, THE DELIVERY SYSTEM IS PRESUMED DISCARDED AND WAS NOT REQUESTED. AS THE LOT NUMBER WAS NOT PROVIDED BY THE SITE, A REVIEW THE LOT HISTORY RECORD (LHR) WAS UNABLE TO BE PERFORMED. A RISK ASSESSMENT REVIEW INDICATES THAT THROMBOSIS IS CAPTURED AS A FORESEEABLE EVENT. A REVIEW OF INSTRUCTIONS FOR USE (IFU) WAS CONDUCTED. THROMBOSIS IS LABELED IN THIS IFU AS A POTENTIAL ADVERSE EVENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WITH ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON AN UNSPECIFIED DATE, A PATIENT UNDERWENT PLANNED PERCUTANEOUS CORONARY INTERVENTION (PCI) VIA DEPLOYMENT OF COBRA PZF¿ (SIZE UNKNOWN) STENT IN AN UNSPECIFIED VESSEL. ON 30 SEP 2020, IT WAS REPORTED TO CELONOVA BIOSCIENCES THAT ON AN UNSPECIFIED DATE, THE PATIENT PRESENTED WITH POSSIBLE STENT THROMBOSIS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED, TO DATE; ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223866 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization