BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBRA PZF

    MDR report key: 7987228 · Received October 19, 2018

    Report

    Report Number
    3009306400-2018-00073
    Event Type
    Death
    Date Received
    October 19, 2018
    Date of Event
    September 20, 2018
    Report Date
    March 25, 2019
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    PMA / PMN Number
    160014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT REVISED: PATIENT CODES: (B)(4) REMOVED. METHOD CODES: 4114 REMOVED; 3331 AND 4117 ADDED. CONCLUSION CODES: 11 REMOVED; 22 AND 4315 ADDED. THE STENT REMAINS IMPLANTED IN PATIENT. AS THERE WAS NO REPORTED DEVICE MALFUNCTION, THE DELIVERY SYSTEM WAS NOT REQUESTED FOR RETURN. A REVIEW OF THE LOT HISTORY RECORD (LHR) WAS PERFORMED. THERE WERE NO NON-CONFORMANCES. THE DEVICES FROM THIS LOT CONFORMS TO THEIR PREDETERMINED SPECIFICATIONS AND REQUIREMENTS. A REVIEW OF THE LOT HISTORY RECORD (LHR) WAS PERFORMED; THERE WERE NO NON-CONFORMANCES. THE DEVICES FROM THIS LOT CONFORMS TO THEIR PREDETERMINED SPECIFICATIONS AND REQUIREMENTS. VENTRICULAR TACHYCARDIA, VENTRICULAR FIBRILLATION, AND DEATH ARE LABELED IN THE INSTRUCTIONS FOR USE AS KNOWN POTENTIAL ADVERSE EVENTS. ANGIOGRAPHY IMAGES WERE RECEIVED AND REVIEWED BY CELONOVA MEDICAL AFFAIRS AND CORE LAB AND CONFIRMED THE INVESTIGATOR'S ASSESSMENT. THE INVESTIGATION DETERMINED THAT A DEFINITIVE CONCLUSIVE CAUSE IS NOT ABLE TO BE ASSIGNED TO THE REPORTED COMPLAINT. HOWEVER, AS THERE WAS NO DEVICE MALFUNCTION, THE REPORTED PATIENT EFFECTS ARE LIKELY DUE TO PATIENT COMORBIDITIES AND / OR VESSEL MORPHOLOGY. PER THE SPONSOR, A RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENTS 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 · 0

    A 75-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY OF CORONARY ARTERY DISEASE, SUPRAVENTRICULAR TACHYCARDIA / ATRIAL FLUTTER S/P PLACEMENT OF PACEMAKER, CONGESTIVE HEART FAILURE, TIA (TRANSIENT ISCHEMIC ATTACK), DIABETES MELLITUS TYPE II, HYPERTENSION, DYSLIPIDEMIA, OBSTRUCTIVE SLEEP APNEA, AUTOIMMUNE HEPATITIS, DEEP VEIN THROMBOSIS, PULMONARY EMBOLUS, MIXED CONNECTIVE TISSUE DISEASE, AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) PRESENTED ON (B)(6) 2018 WITH STABLE ANGINA WITH ABNORMAL STRESS TEST. THE PATIENT ENROLLED IN COBRA TRIAL. ANGIOGRAPHY PERFORMED (B)(6) 2018 REVEALED SEVERELY STENOSED, CALCIFIED B2 TYPE LESIONS IN THE MID AND DISTAL LCX. THE PATIENT WAS PRELOADED WITH CLOPIDOGREL. BIVALIRUDIN ANTICOAGULATION WITH THERAPEUTIC ACT. AFTER INTRODUCING A 6F GUIDE CATHETER VIA RADIAL ACCESS, PRE-DILATATION OF THE MID AND DISTAL LESIONS WAS PERFORMED WITH A 3MM BALLOON. ST-SEGMENT ELEVATION AND HEMODYNAMIC CHANGE WERE NOTED. AFTER DEPLOYMENT OF THE 1ST STENT (4.0X24MM COBRA PZF¿ PLACED IN DISTAL LCX), SLUGGISH FLOW OCCURRED DUE TO ABRUPT VESSEL CLOSURE, DESPITE GOOD STENT EXPANSION. A 4.0X18MM COBRA PZF¿ NANOCOATED STENT WAS THEN PLACED PROXIMAL TO THE 1ST DEPLOYED STENT. ST-SEGMENT ELEVATION AND HYPOTENSION WERE OBSERVED. CATECHOLAMINE SUPPORT AND INTRA-CORONARY ADENOSINE (200MCG) WAS GIVEN, AND CPR WAS STARTED. EPINEPHRINE WAS ADMINISTERED AND THE PATIENT WAS INTUBATED. IMPELLA PUMP WAS INSERTED INTO THE LEFT VENTRICLE VIA RIGHT FEMORAL ACCESS; 4MM BALLOON DILATATION OF THE CX WAS PERFORMED WITH NO FLOW IMPROVEMENT. THE PATIENT DEVELOPED RECURRENT VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF) AND WAS SHOCKED. THERE WAS NO RETURN OF PULSE, DESPITE BEING SHOCKED SEVERAL TIMES. CARDIOTHORACIC SURGERY WAS EMERGENTLY CALLED TO THE OPERATION ROOM. AFTER CONSULTATION THE PATIENT WAS NOT FELT TO BE A CANDIDATE FOR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). RESUSCITATIVE EFFORTS WERE DISCONTINUED. THERE WAS NO PULSE, OR SPONTANEOUS RESPIRATIONS. THE PATIENT WAS PRONOUNCED DECEASED IN THE CATH LAB DUE TO CARDIAC ARREST. PER THE PHYSICIAN, THERE WAS NO EVIDENCE OF THROMBUS OR DISSECTION. AUTOPSY WAS REQUESTED, BUT FAMILY DECLINED. PER THE INVESTIGATOR, THIS EVENT IS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THE SPONSOR AGREES WITH THIS ASSESSMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IMPLANTED IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WITH ADDITIONAL RELEVANT INFORMATION WILL BE PROVIDED. THE OTHER COBRA PZFF STENT IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    A (B)(6) YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY OF CORONARY ARTERY DISEASE, DIABETES MELLITUS TYPE II, HYPERTENSION, DYSLIPIDEMIA, LIVER DISEASE, AND EX-SMOKER PRESENTED ON (B)(6) 2018 WITH STABLE ANGINA. THE PATIENT ENROLLED IN (B)(6) STUDY. ANGIOGRAPHY PERFORMED (B)(6) 2018 REVEALED A LESION IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) CORONARY ARTERY AND A LESION IN THE DISTAL LCX. AFTER INTRODUCING A 6F GUIDE CATHETER VIA RADIAL ACCESS, PRE-DILATATION WAS PERFORMED WITH A 3.0MM MEDTRONIC EUPHORA BALLOON, FOLLOWED BY DEPLOYMENT OF A 4.0X18MM COBRA PZF NANOCOATED STENT THEN A 4.0X24MM COBRA PZF STENT. POST STENT DEPLOYMENT, THERE WAS NO TIMI FLOW IN THE LCX. THE PATIENT EXPERIENCED CARDIAC ARREST DUE TO THROMBOSIS AND CORONARY ARTERY DISSECTION. A 4MM BALLOON WAS ADVANCED DOWN THE CIRCUMFLEX AND WAS INFLATED TO NOMINAL PRESSURE THROUGHOUT THE CIRCUMFLEX. THERE WAS NO IMPROVEMENT IN FLOW. THE PATIENT DEVELOPED VENTRICULAR TACHYCARDIA / VENTRICULAR FIBRILLATION (VF) AND WAS SHOCKED. THERE WAS NO RETURN OF PULSE. THE PATIENT DEVELOPED COARSE VF AND WAS SHOCKED SEVERAL TIMES. THE PATIENT EXPIRED THE SAME DAY. PER THE INVESTIGATOR, THIS EVENT IS POSSIBLY RELATED TO THE STUDY DEVICE AND THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827812 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. NA 1709064004

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| R STENT: 4.0X24MM COBRA PZF