BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBRA PZF

    MDR report key: 7797556 · Received August 20, 2018

    Report

    Report Number
    3009306400-2018-00051
    Event Type
    Death
    Date Received
    August 20, 2018
    Date of Event
    April 19, 2017
    Report Date
    August 20, 2018
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397007417
    PMA / PMN Number
    160014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE STENT REMAINS IMPLANTED IN THE PATIENT, AND THE EVENT OCCURRED MORE THAN THREE MONTHS AFTER THE INDEX PROCEDURE, THE DEVICE WAS NOT REQUESTED FOR RETURN. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE ABOVE 3.5 X 18MM COBRA LOT CONFIRMED THAT THIS DEVICE MET ITS PREDETERMINED MANUFACTURING SPECIFICATIONS WITH NO REPORTED DEVICE MALFUNCTIONS AND WITH NO NON-CONFORMANCE'S. DEATH IS LABELED IN THE COBRA PZF INSTRUCTIONS FOR USE AS A KNOWN POTENTIAL ADVERSE EVENT. THE INVESTIGATOR AND THE SPONSOR BELIEVE THAT PATIENT'S AGE AND THE MULTIPLE COMORBIDITIES LISTED ABOVE MOST LIKELY CONTRIBUTED TO PATIENT'S DEATH. 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: 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 ((B)(6) 2018) THAT THE EVENT SHOULD BE CONSERVATIVELY REPORTED. THE 2.75X15MM AND 2.5X18MM COBRA PZF STENTS REFERENCED ARE BEING FILED UNDER SEPARATE MFR NUMBERS.

    Description of Event or Problem · 1

    PER THE MEDICAL AFFAIRS' ASSESSMENT: AN (B)(6) MALE WITH A HISTORY OF CORONARY ARTERY DISEASE, ATRIAL FIBRILLATION (ON ORAL ANTICOAGULANT), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), HYPERCHOLESTEROLEMIA, AND SMOKING (20 CIGARETTES PER DAY) PRESENTED TO THE HOSPITAL WITH INFERIOR ACUTE ST ELEVATED MYOCARDIAL INFARCTION (STEMI). A CORONARY ANGIOGRAPHY SHOWED 80% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY AND SUB OCCLUSIVE THROMBOTIC LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS ENROLLED IN THE (B)(6) REGISTRY AND RECEIVED TWO PZF COBRA STENTS (2.75X15 MM AND 2.5X18 MM) IN THE MID LAD AND MID RCA WITHOUT PRE-DILATION ((B)(6) 2016). APPROXIMATELY FIVE WEEKS LATER ((B)(6) 2017), THE PATIENT WAS ADMITTED FOR RESPIRATORY INFECTION AND AT THE SAME TIME CHEST PAIN SIMILAR TO THE INITIAL MI. THE PATIENT HAD ANTIBIOTICS TREATMENT FOR THE INFECTION AND FIBRINOLYSIS TREATMENT FOR THE MI, AND WAS TAKEN TO THE CATH LAB. CORONARY ANGIOGRAPHY SHOWED A PATENT MID LAD STENT AND A THROMBUS IN THE MID RCA AT THE IMPLANTED STENT (2.5X18MM COBRA PZF) WITH TIMI FLOW 3. THE PATIENT HAD A SUCCESSFUL RECANALISATION WITH THROMBECTOMY (4 PASSAGES) ALONE WITH A FINAL CORONARY ANGIOGRAPHY SHOWING A LESION LESS THAN 30% STENOSIS. THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY AND ORAL ANTICOAGULANT. THREE WEEKS LATER ((B)(6) 2017), THE PATIENT RETURNED FOR A CONTROL CORONARY ANGIOGRAPHY AND SHOWED WORSENED LESION ABOUT 50- 70% STENOSIS IN THE PROXIMAL RCA AND PATENT STENT IN THE MID RCA. IN ADDITION, A MAL-APPOSITION WAS NOTED AT THE DISTAL PART OF THE (2.5X18 MM COBRA PZF) STENT, POSSIBLY DUE TO ULCERATED PLAQUE DISLODGMENT. THE PROXIMAL RCA LESION WAS TREATED WITH 3.5X18 MM PZF COBRA STENT WITHOUT PRE-DILATION AND POST-DILATION WAS PERFORMED OF THE PREVIOUSLY IMPLANTED STENT WITH SUCCESSFUL RESULTS. APPROXIMATELY THREE AND HALF MONTHS ((B)(6) 2017) AFTER THE PROCEDURE, THE PATIENT WAS HOSPITALIZED FOR DECOMPENSATED CARDIAC FAILURE AND ACUTE RESPIRATORY FAILURE. THE PATIENT WAS INTUBATED AND PUT ON MECHANICAL VENTILATION, AND WAS TREATED WITH DIURETICS AND DIGOXIN. FOUR DAYS LATER, THE PATIENT WAS EXTUBATED AND TREATED MEDICALLY FOR EPISODES OF ATRIAL FIBRILLATION WITH SOME IMPROVEMENT IN RENAL FUNCTION. AFTER A REVIEW WITH THE MUTLI-DISCIPLINARY TEAM AND CARDIOLOGISTS, DUE TO THE ADVANCED CARDIAC AND RESPIRATORY DISEASES, IT WAS AGREED WITH THE PATIENT AND FAMILY TO PROVIDE COMFORT CARE WITHOUT ANY INVASIVE TREATMENT. THE PATIENT EXPIRED A WEEK LATER ((B)(6) 2017) IN THE HOSPITAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640177 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 1606144001 00879397007417

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| H| R STENT: 2.75 X15MM AND 2.5 X 18MM COBRA PZF