BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBRA PZF

    MDR report key: 7801169 · Received August 21, 2018

    Report

    Report Number
    3009306400-2018-00054
    Event Type
    Death
    Date Received
    August 21, 2018
    Date of Event
    March 31, 2017
    Report Date
    August 21, 2018
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    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 WAS IMPLANTED (B)(6) 2016 AND THERE WERE NO COMPLAINTS AGAINST THE STENT OR ASSOCIATED DELIVERY SYSTEM, THE DEVICE WAS NOT REQUESTED FOR RETURN. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. THE INVESTIGATOR INDICATED THAT THE DEATH IS UNRELATED TO THE INDEX PROCEDURE AND UNRELATED TO THE IMPLANTED STUDY DEVICES. THE SPONSOR AGREES WITH THE INVESTIGATOR; THE PATIENT DEATH IS LIKELY ATTRIBUTED TO PATIENT AGE, MEDICAL HISTORY, MULTIPLE COMORBIDITIES, AND A GENERAL DECLINE IN STATE OF HEALTH. HOWEVER, DUE TO THE ABSENCE OF AUTOPSY, THE RELATEDNESS OF DEATH TO THE DEVICES COULD NOT BE COMPLETELY 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 DEFICIENCY WITH RESPECT TO DESIGN, PERFORMANCE, OR LABELING OF THIS DEVICE. DEATH IS LABELED IN THE COBRA PZF INSTRUCTIONS FOR USE AS A KNOWN POTENTIAL ADVERSE EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY WITH RESPECT TO DESIGN, PERFORMANCE, OR LABELING OF THIS DEVICE. AWARE DATE NOTE: AWARE DATE NOTE: CELONOVA BIOSCIENCES WAS INITIALLY MADE AWARE OF THIS EVENT ON 05-SEP-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 2.5 X 18 MM COBRA PZF STENT REFERENCED IN DESCRIBE EVENT OR PROBLEM AND CONCOMITANT MEDICAL PRODUCTS IS BEING FILED UNDER SEPARATE MFR NUMBER.

    Description of Event or Problem · 1

    A (B)(6) MALE WITH MEDICAL HISTORY OF ISCHEMIC HEART DISEASE, CHRONIC KIDNEY DISEASE, COPD, CIRRHOSIS WITH LEFT HEPATECTOMY, CACHEXIA, AND DIABETES MELLITUS (DM) TYPE 2 PRESENTED ON (B)(6) 2016 WITH NON-ST-ELEVATED MYOCARDIAL INFARCTION (NSTEMI). PATIENT ENROLLED IN COBRA TRIAL. PERCUTANEOUS CORONARY INTERVENTION (PCI) PERFORMED WITH COBRA PZF STENT (2.5 X 18 MM) IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, AND COBRA PZF STENT (2.75 X 18 MM) TO THE RIGHT CORONARY ARTERY (RCA). THE PATIENT HAD RECURRENT HOSPITALIZATIONS DUE TO COMPLICATION FROM CHRONIC MEDICAL CONDITIONS. ON (B)(6) 2016, THE PATIENT WAS ADMITTED DUE TO SEVERE SEPSIS WITH ANEMIA, ASCITES, AND BILATERAL PLEURAL EFFUSION TREATED WITH ANTIBIOTICS AND BLOOD TRANSFUSION AND WAS DISCHARGED ON (B)(6) 2016. PATIENT WAS HOSPITALIZED, AGAIN FROM (B)(6) 2016, DUE TO HEART FAILURE WITH RIGHT PLEURAL EFFUSION. ON (B)(6) 2017 HE WAS ADMITTED DUE TO TRANSUDATE HEMOTHORAX AND TREATED WITH INTERCOSTAL DRAIN (800 ML BLOODY FLUID WITH NEGATIVE GRAM STAIN). DURING THE ADMISSION, THE PATIENT HAD ANEMIA (HEMOGLOBIN 9-10 G), WORSENING CHRONIC RENAL FAILURE (CREATININE 18), AND HYPERNATREMIA (NA= 155). PATIENT WAS DISCHARGED ON (B)(6) 2017. THE PATIENT WAS TAKING AMIODARONE, INSULIN, CONVERSYL, LASIX, AND PAXIL MEDICATIONS. DURING A 12-MONTH FOLLOW-UP PHONE CALL TO PATIENT ON 30-AUG-2017, THE SPOUSE OF THE PATIENT REPORTED THAT THE PATIENT HAD CARDIAC ARREST ON (B)(6) 2017. THE TREATING PHYSICIAN CONFIRMED THAT THE PATIENT HAD HEPATIC FAILURE WITH HEPATIC ENCEPHALOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643807 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death STENT: 2.5 X 18MM COBRA PZF