BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBRA PZF

    MDR report key: 10068100 · Received May 18, 2020

    Report

    Report Number
    3009306400-2020-00019
    Event Type
    Death
    Date Received
    May 18, 2020
    Date of Event
    April 22, 2020
    Report Date
    May 18, 2020
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397007219
    PMA / PMN Number
    P160014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED, BUT STENT REMAINS IMPLANTED IN PATIENT AND DELIVERY SYSTEM IS PRESUMED DISCARDED. A REVIEW OF THE LOT HISTORY RECORD (LHR) WAS PERFORMED. THERE WERE NO NON-CONFORMANCES. THE LOT CONFORMS TO ITS PREDETERMINED SPECIFICATIONS AND REQUIREMENTS. DEATH IS CAPTURED IN THE RISK ASSESSMENT AS A KNOWN POTENTIAL HARM AND LISTED IN THE INSTRUCTIONS FOR USE AS KNOWN POTENTIAL ADVERSE EVENT. THE PRINCIPAL INVESTIGATOR INDICATED THAT THE EVENT IS NOT RELATED TO INDEX PROCEDURE AND POSSIBLY RELATED TO STUDY DEVICE. WHILE THE EXACT CAUSE OF EVENT IS UNABLE TO BE DETERMINED, PATIENT COMBORBIDITIES AND VESSEL MORPHOLOGY ARE THE MOST PROBABLE CONTRIBUTORS TO THE EVENT. PER THE SPONSOR, A RELATIONSHIP BETWEEN THE COBRA STENT AND REPORTED ADVERSE EVENT CANNOT BE COMPLETELY EXCLUDED. ADDITIONALLY, IN THE ABSENCE OF AN AUTOPSY OR ADDITIONAL ANGIOGRAM, A STENT THROMBOSIS CANNOT BE COMPLETELY RULED OUT. 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 · 1

    AN (B)(6)-YEAR-OLD MALE WITH MEDICAL HISTORY OF DIABETES MELLITUS TYPE II, HYPERTENSION, PERIPHERAL VASCULAR DISEASE (DIAGNOSED IN 2005), ATRIAL FIBRILLATION, EJECTION FRACTION 50% ((B)(6) 2019), AND EX-SMOKER PRESENTED WITH STABLE ANGINA AND ENROLLED IN A COBRA TRIAL. CORONARY ANGIOGRAPHY PERFORMED (B)(6) 2019 SHOWED 50% OR GREATER LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY AND TYPE A, 72% STENOTIC LESION IN THE RAMUS CORONARY ARTERY. THE RAMUS WAS SELECTED FOR TREATMENT WITH A CORONARY STENT. AFTER PERFORMING PRE-DILATATION, A 2.5X12MM COBRA PZF¿ NANOCOATED CORONARY STENT SYSTEM WAS ADVANCED VIA RADIAL ACCESS TO A LESION IN THE RAMUS CORONARY ARTERY, AND THE STENT WAS DEPLOYED WITH NO POST-DILATATION REQUIRED. THE PATIENT WAS DISCHARGED TO HOME THE FOLLOWING DAY. AT 14-DAY FOLLOW-UP PHONE CALL, NO ADVERSE EVENTS WERE REPORTED, AND PATIENT HAD MAINTAINED COMPLIANCE WITH DUAL ANTI-PLATELET THERAPY (DAPT). AT 30-DAY FOLLOW-UP PHONE CALL, NO ADVERSE EVENTS WERE REPORTED. DURING 6-MONTH FOLLOW-UP PHONE CALL, IT WAS REPORTED THAT THE PATIENT HAD DECEASED AT HOME DUE TO CARDIAC ARREST. PER THE PRINCIPLE INVESTIGATOR, THE EVENT IS NOT RELATED TO THE INDEX PROCEDURE, BUT POSSIBLY RELATED TO THE STUDY DEVICE. IN THE ABSENCE OF AN AUTOPSY OR ADDITIONAL ANGIOGRAM, A STENT THROMBOSIS CANNOT BE COMPLETELY RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530157 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 1903154001 00879397007219

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death