BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBRA PZF

    MDR report key: 7809477 · Received August 23, 2018

    Report

    Report Number
    3009306400-2018-00061
    Event Type
    Death
    Date Received
    August 23, 2018
    Date of Event
    December 25, 2016
    Report Date
    August 23, 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 REMAINS IN THE PATIENT, AND THE EVENT OCCURRED MORE THAN 12 MONTHS AFTER IMPLANTATION OF THE STENT, THE DEVICE WAS NOT REQUESTED FOR RETURN. AS THE LOT NUMBER WAS NOT REPORTED, A REVIEW OF THE DEVICE LOT HISTORY RECORD WAS UNABLE TO BE CONDUCTED. DEATH IS LABELED IN THE COBRA PZF INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT. THE INVESTIGATOR INDICATED THAT THE EVENT IS NOT RELATED TO THE STUDY DEVICE OR INDEX PROCEDURE. THE INVESTIGATOR LEARNED OF THE PATIENT DEATH (IN THE HOME), DURING 12-MONTH FOLLOW-UP; THE CAUSE OF DEATH WAS NOT PROVIDED AND NO AUTOPSY REPORT WAS PROVIDED. PER THE SPONSOR, WHILE THE CAUSE OF DEATH IS MOST LIKELY RELATED TO PATIENT'S ADVANCED AGE, IN ADDITION TO ASSOCIATED COMORBIDITIES (ARTERIAL HYPERTENSION, PROSTATECTOMY, AORTIC STENOSIS, AND PRIOR STEMI), RELATEDNESS OF A CARDIAC DEATH OR POSSIBLE LATE STENT THROMBOSIS TO THE STUDY DEVICE CANNOT 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 QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING; THERE IS NO EVIDENCE OF A DEVICE DEFICIENCY. AWARE DATE NOTE: CELONOVA BIOSCIENCES WAS INITIALLY MADE AWARE OF THIS EVENT ON (B)(6) 2018; 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.

    Description of Event or Problem · 1

    ON (B)(6) 2015, AN (B)(6) MALE WITH A HISTORY OF ARTERIAL HYPERTENSION, PROSTATECTOMY, AORTIC STENOSIS PRESENTED WITH AN ST-ELEVATED MYOCARDIAL INFARCTION (STEMI). THE PATIENT ENROLLED IN ECOBRA STUDY. A 2.5X24MM COBRA PZF NANOCOATED STENT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH NO REPORTED ISSUES. APPROXIMATELY 12 MONTHS AFTER THE INDEX PROCEDURE, DURING FOLLOW-UP PHONE CALL, THE PHYSICIAN WAS INFORMED THAT THE PATIENT HAD DIED AT HOME ON (B)(6) 2016. CAUSE OF DEATH WAS NOT REPORTED. THE INVESTIGATOR INDICATED THAT THE EVENT IS NOT RELATED TO THE STUDY DEVICE OR INDEX PROCEDURE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649102 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death