BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBRA PZF

    MDR report key: 7112799 · Received December 13, 2017

    Report

    Report Number
    3009306400-2017-00017
    Event Type
    Death
    Date Received
    December 13, 2017
    Date of Event
    September 12, 2017
    Report Date
    January 10, 2018
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    PMA / PMN Number
    P160014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IMPLANTED IN THE PATIENT. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ANY ADDITIONAL RELEVANT INFORMATION. THE 2.5X15 MM COBRA PZF STENT MENTIONED IN DESCRIBE EVENT OR PROBLEM AND CONCOMITANT MEDICAL PRODUCTS IS BEING REPORTED UNDER MANUFACTURER'S REPORT NUMBER 3009306400-2017-00018.

    Additional Manufacturer Narrative · 1

    PATIENT DEATH IS UNRELATED TO DEVICE OR INDEX PROCEDURE. (B)(4). AS THE STENT REMAINS IMPLANTED IN THE PATIENT AND THERE WAS NO REPORTED DEVICE MALFUNCTION, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. AS THE LOT NUMBER INFORMATION WAS NOT REPORTED, A REVIEW OF THE LOT HISTORY RECORD (LHR) WAS UNABLE TO BE CONDUCTED. WHILE DEATH IS LISTED IN THE COBRA PZF CSS INSTRUCTIONS FOR USE AS A LABELED POTENTIAL ADVERSE EVENT, THE INVESTIGATOR HAS DETERMINED THAT THERE IS NO RELATIONSHIP BETWEEN PATIENT DEATH AND DEVICE, OR PATIENT DEATH AND INDEX PROCEDURE. THE SPONSOR AGREES WITH THE INVESTIGATOR'S MEDICAL ASSESSMENT, AND HAS DETERMINED THAT, IN ADDITION TO MULTIPLE PRE-EXISTING COMORBIDITIES, ADVANCED AGE, AND GENERAL DECLINE IN HEALTH, THE CAUSE OF DEATH IS ACUTE RESPIRATORY DISTRESS SYNDROME DUE TO ASPIRATION PNEUMONIA; IT IS NOT RELATED TO THE DEVICE OR THE INDEX PROCEDURE. 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) MALE PATIENT WITH MEDICAL HISTORY OF ARTERIAL HYPERTENSION, PARKINSON'S DISEASE, AND HEART FAILURE WITH REDUCED EJECTION FRACTION (EF=40%), PRESENTED WITH NON-ST-ELEVATED MYOCARDIAL INFARCTION (NSTEMI) ON (B)(6) 2016 AND WAS ENROLLED IN A COBRA TRIAL. PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON (B)(6) 2016 WITH TWO COBRA PZF NANOCOATED STENTS (A 2.75X24 MM AND A 2.5X15 MM) IMPLANTED IN THE CIRCUMFLEX (CX) CORONARY ARTERY. DURING 12-MONTH FOLLOW-UP, IT WAS DISCOVERED THAT THE PATIENT HAD DECEASED DUE TO AN UNSPECIFIED REASON ON (B)(6) 2017. ADDITIONAL INFORMATION WAS REQUESTED.

    Description of Event or Problem · 1

    AN (B)(6) MALE PATIENT WITH MEDICAL HISTORY OF CORONARY ARTERY DISEASE, ARTERIAL HYPERTENSION, HEART FAILURE WITH REDUCED EJECTION FRACTION (EF=40%), PACEMAKER WITH RECURRENT BRADYCARDIA, PARKINSON'S DISEASE WITH SWALLOWING DISORDER, ALZHEIMER'S DISEASE, AND CHRONIC (B)(6). THE PATIENT PRESENTED ON (B)(6) 2016 WITH NON-ST-ELEVATED MYOCARDIAL INFARCTION (NSTEMI) AND WAS ENROLLED IN A COBRA TRIAL. PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON (B)(6) 2016 WITH TWO COBRA PZF NANOCOATED STENTS (A 2.75X24MM AND A 2.5X15MM) IMPLANTED IN THE CIRCUMFLEX (CX) CORONARY ARTERY. DURING 12-MONTH FOLLOW-UP, IT WAS DISCOVERED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2017 WITH ASPIRATION PNEUMONITIS SECONDARY TO VOMITING, AND ACUTE RESPIRATORY INSUFFICIENCY. DURING THE HOSPITALIZATION, THE PATIENT WAS HYPOXIC WITH PO2AT 60 MMHG, PCO2 AT 26 MMHG, PH AT 7.49 AND OXYGEN SATURATION AT 93%. BLOOD WORK SHOWED AN INFLAMMATORY SYNDROME WITH CRP AT 94 MG/L AND WBC AT 13.5 MCL. CHEST CT SCAN SHOWED MODERATE BILATERAL PLEURITIS WITH BILATERAL PNEUMOPATHY AFFECTING ALL LOBES. THE PATIENT STARTED ON ANTIBIOTIC THERAPY WITH ROCEPHINE AND FLAGYL. LATER ADDED HYPNOVEL AND MORPHINE PCA TO REDUCE TACHYPNEA. IN AGREEMENT WITH THE FAMILY, THE PATIENT WAS PUT ON COMFORT CARE WITHOUT RESUSCITATION. THE PATIENT'S CONDITION WAS FURTHER DETERIORATED AND HE DECEASED ON (B)(6) IN THE PRESENCE OF HIS WIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893153 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death STENT: 2.5X15MM COBRA PZF