BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBRA PZF

    MDR report key: 7793086 · Received August 17, 2018

    Report

    Report Number
    3009306400-2018-00043
    Event Type
    Death
    Date Received
    August 17, 2018
    Date of Event
    March 30, 2017
    Report Date
    August 17, 2018
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    PMA / PMN Number
    160014
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE STENT REMAINS IMPLANTED IN THE PATIENT, THERE WAS NO REPORTED DEVICE ISSUE, AND THE INDEX PROCEDURE WAS APPROXIMATELY 4 MONTHS PRIOR TO THE EVENT, THE DEVICE WAS NOT REQUESTED FOR RETURN. THE REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AT THIS TIME AS THE LOT NUMBER HAS NOT BEEN PROVIDED. DEATH IS LISTED IN THE COBRA PZF INSTRUCTIONS FOR USE AS A LABELED POTENTIAL ADVERSE EVENT. THE INVESTIGATOR BELIEVES THE DEATH WAS NOT RELATED TO THE DEVICE OR THE PROCEDURE. THE SPONSOR AGREES WITH THE INVESTIGATOR. THE PATIENT AGE, TRAUMATIC FALL AND POSSIBLE INTRACRANIAL HEMORRHAGE, AND MULTIPLE CO-MORBIDITIES LISTED ABOVE ARE MOST LIKELY CONTRIBUTED TO THE EVENT. HOWEVER, DUE TO THE ABSENCE OF AUTOPSY, THE RELATEDNESS TO THE DEVICE COULD NOT BE 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. AWARE DATE NOTE: CELONOVA BIOSCIENCES WAS INITIALLY MADE AWARE OF THIS EVENT ON (B)(6) 2017; AS THIS EVENT HAD OCCURRED PRIOR TO U.S. PRODUCT APPROVAL, IT WAS NOT REPORTED AT THAT TIME. PER CELONOVA BIOSCIENCES MANAGEMENT REVIEW OF COMPLAINTS, IT WAS DETERMINED BY MANAGEMENT (02-AUG-2018) THAT THE EVENT SHOULD BE CONSERVATIVELY REPORTED.

    Description of Event or Problem · 1

    PER THE MEDICAL AFFAIRS' ASSESSMENT: AN (B)(6) MALE WITH MEDICAL HISTORY OF CORONARY ARTERY DISEASE WITH PROGRESSIVE HEART DISEASE FOR OVER 20 YEARS, ACUTE CORONARY SYNDROME TREATED WITH CORONARY ARTERY BYPASS GRAFTING (CABG) IN 1995, HYPERTENSION, ATRIAL FIBRILLATION (ON ORAL ANTICOAGULATION) AND LOWER LIMBS ARTERIOPATHY (ONE WEEK PRIOR) PRESENTED WITH ACUTE CORONARY SYNDROME WITH POSITIVE TROPONIN. CORONARY ANGIOGRAPHY SHOWED A CHRONIC OCCLUSION IN THE RCA, AN OCCLUDED GASTROEPIPLOIC BRIDGE, AN OCCLUDED MARGINAL DIAGONAL BRIDGE, AND A FUNCTIONAL MID LAD LEFT MAMMARY BRIDGE, ONE LESION IN A MARGINAL BRANCH (RAMUS INTERMEDIUS) AND ONE IN A SECOND MARGINAL BRANCH. PRESERVED LEFT VENTRICLE EF NOTED. THE PATIENT WAS ENROLLED IN ECOBRA REGISTRY AND IMPLANTED WITH 2.5X12MM COBRA PZF STENT IN AN M1 SEGMENT BIFURCATION (1ST OBTUSE MARGINAL CORONARY ARTERY) ON (B)(6) 2016. THREE DAYS LATER, THE PATIENT EXPERIENCED EPISODES OF 2:1 ATRIOVENTRICULAR BLOCKS. SOME ARRHYTHMIA AND INTERMITTENT BRANCH BLOCK WERE ALSO NOTED. ISOPTINE MEDICATION WAS DISCONTINUED AS A RESULT. THE PATIENT WAS DISCHARGED 4 DAYS AFTER THE PROCEDURE ON ASPIRIN, PLAVIX, AND XARELTO FOR 1 MONTH, THEN PLAVIX AND XARELTO FOR A YEAR. THE PATIENT TESTED SOME RESISTANT TO PLAVIX AND THE DOSE WAS ADJUSTED ACCORDINGLY. APPROXIMATELY 4 MONTHS AFTER THE PROCEDURE, THE PATIENT WAS BROUGHT TO THE EMERGENCY DEPARTMENT DUE TO A FALL WITH FOREHEAD WOUND, TRAUMATIC BRAIN INJURY, AND LOSS OF CONSCIOUSNESS. CARDIOPULMONARY RESUSCITATION WITH THE USE OF DEFIBRILLATOR WAS INITIATED, AND THE PATIENT WAS INTUBATED AND PLACED ON MECHANICAL VENTILATION. ELECTROCARDIOGRAM (ECG) SHOWED ASYSTOLE. AFTER DISCUSSION WITH THE FAMILY, THE RESUSCITATION WAS STOPPED AND THE PATIENT EXPIRED ((B)(6) 2017). NO AUTOPSY WAS PERFORMED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633961 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death| H| R