BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBRA PZF

    MDR report key: 7794226 · Received August 17, 2018

    Report

    Report Number
    3009306400-2018-00046
    Event Type
    Death
    Date Received
    August 17, 2018
    Date of Event
    January 31, 2017
    Report Date
    August 17, 2017
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397007387
    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, THERE WAS NO REPORTED DEVICE ISSUE, AND THE INDEX PROCEDURE WAS APPROXIMATELY 7 WEEKS PRIOR TO THE EVENT, THE DEVICE WAS NOT REQUESTED FOR RETURN. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT CONFIRMED THAT THE DEVICES FROM THIS LOT MET THEIR PREDETERMINED MANUFACTURING SPECIFICATIONS WITH NO REPORTED DEVICE MALFUNCTIONS AND NO NON-CONFORMANCES. DEATH IS LISTED IN THE COBRA PZF INSTRUCTIONS FOR USE AS A LABELED POTENTIAL ADVERSE EVENT. THE INVESTIGATOR BELIEVES THE EVENT IS NOT RELATED TO THE DEVICE OR THE PROCEDURE. THE SPONSOR AGREES WITH THE INVESTIGATOR DUE TO ADVANCED PATIENT AGE AND AFOREMENTIONED MULTIPLE COMORBIDITIES THAT MOST LIKELY CONTRIBUTED TO THE EVENT. HOWEVER, DUE TO THE ABSENCE OF AUTOPSY, THE RELATEDNESS TO THE DEVICE COULD NOT BE RULED OUT. IN THIS CASE, NO PRODUCT MALFUNCTION, FAILURE OR DETERIORATION OF CHARACTERISTIC OR PERFORMANCE OF THE DEVICE, OR INADEQUACY IN THE LABELING AND/OR INSTRUCTIONS FOR USE WAS IDENTIFIED. 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 19-JUL-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. THE OTHER COBRA PZF STENT REFERENCED ARE BEING FILED UNDER SEPARATE MFR REPORT NUMBER.

    Description of Event or Problem · 1

    PER THE MEDICAL AFFAIRS' ASSESSMENT: AN (B)(6) MALE WITH A HISTORY OF CORONARY ARTERY DISEASE, PRIOR DUAL CORONARY ARTERY BYPASS GRAFTING (CABG) AND PERCUTANEOUS CORONARY INTERVENTION (EJECTION FRACTION: 45%), ARTERIAL HYPERTENSION, ATRIAL FIBRILLATION (ON ORAL ANTICOAGULANT), OCCLUSIVE ARTERIOPATHY OF THE LOWER LIMBS WITH PRIOR PERIPHERAL SURGERY, BILATERAL CAROTID ENDARTERECTOMY, INSULIN-DEPENDENT DIABETES, CHRONIC RENAL FAILURE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, HIATAL HERNIA AND SMOKING PRESENTED WITH LIGHT HEADEDNESS ON EXERTION FOR SEVERAL WEEKS AND SYNCOPE. HIS STRESS TEST WAS POSITIVE AND UNDERWENT CORONARY ANGIOGRAPHY, WHICH SHOWED CHRONIC OCCLUSION AT THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH BRIDGING TOWARDS MID RCA, CHRONIC OCCLUSION AT THE RIGHT SAPHENOUS VEIN GRAFT (SVG) TO DISTAL RCA, SIGNIFICANT ECCENTRIC NARROWING AT THE OSTIUM OF THE LEFT MAIN ARTERY, AND SIGNIFICANT STENOSIS (70-90%) TYPE B1 LESION AT THE PROXIMAL CIRCUMFLEX ARTERY. THE PATIENT WAS ENROLLED IN COBRA TRIAL AND ((B)(6) 2016) UNDERWENT A DEPLOYMENT OF TWO COBRA PZF STENTS; 3.0X18 MM STENT IN THE PROXIMAL CIRCUMFLEX ARTERY (AT 16 ATMOSPHERES (ATM)), AND A 3.5X8 MM IN THE OSTIAL LEFT MAIN (AT 18 ATM) WITH NO PRE-DILATION. POST DILATION WAS PERFORMED WITH NON-COMPLIANT BALLOON. THE FINAL ANGIOGRAPHIC RESULT WAS SATISFACTORY. THE PATIENT WAS DISCHARGED HOME ON PLAVIX AND ORAL ANTICOAGULANT. DURING THE 6-MONTH FOLLOW UP BY THE INVESTIGATIVE SITE, THE FAMILY REPORTED THE PATIENT WAS DECEASED FROM CARDIAC ARREST ((B)(6) 2017) AT HOME APPROXIMATELY 7 WEEKS AFTER THE INDEX PROCEDURE. NO AUTOPSY WAS PERFORMED. THE INVESTIGATOR REPORTED THAT THE EVENT IS NOT RELATED TO THE DEVICE OR THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636075 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 1502044003 00879397007387

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death STENT: 3.0 X 18MM COBRA PZF