BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBRA PZF

    MDR report key: 6981355 · Received October 26, 2017

    Report

    Report Number
    3009306400-2017-00013
    Event Type
    Death
    Date Received
    October 26, 2017
    Date of Event
    June 1, 2017
    Report Date
    December 15, 2017
    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

    DATE OF EVENT IS ESTIMATED. THE STENT REMAINS IMPLANTED IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ANY RELEVANT ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS THE STENT REMAINS IMPLANTED IN THE PATIENT AND THERE WAS NO REPORTED DEVICE MALFUNCTION, IT 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. 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 THE PATIENT DEATH IS LIKELY ATTRIBUTED TO PATIENT'S ADVANCED AGE, MEDICAL HISTORY, AND POSSIBLY A GENERAL DECLINE IN STATE OF HEALTH. HOWEVER, DUE TO THE ABSENCE OF AN EXACT CAUSE OF DEATH AND ABSENCE OF AN AUTOPSY, THE RELATEDNESS OF DEATH TO THE DEVICE COULD NOT BE COMPLETELY RULED OUT. 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

    IT WAS REPORTED THAT ON (B)(6) 2016, AN (B)(6) YEAR OLD FEMALE PATIENT WITH A MEDICAL HISTORY OF ARTERIAL HYPERTENSION, ATRIAL FIBRILLATION, HYPERCHOLESTEROLEMIA, AND AN EJECTION FRACTION OF 65% PRESENTED WITH A NON-ST ELEVATED MYOCARDIAL INFARCTION (STEMI). THE PATIENT WAS ENROLLED IN THE (B)(6) STUDY AND A 3.0X18MM COBRA PZF STENT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE PATIENT EXPERIENCED AN UNRELATED FALL (B)(6) 2017 WITH HOSPITALIZATION, WAS DISCHARGED (B)(6) 2017, WITH THE CASE REVIEWED (B)(6) 2017 WITH NO DEATH OR ANY OTHER ADVERSE PATIENT SEQUELAE REPORTED AT THAT TIME. DURING 12-MONTH STUDY FOLLOW-UP, IT WAS DISCOVERED THAT, WHILE THERE WAS NO REPORTED MAJOR CARDIAC EVENT, THE PATIENT HAD EXPIRED DUE TO AN UNKNOWN REASON, AT AN UNKNOWN DATE, SOMETIME AFTER THE 6-MONTH FOLLOW-UP. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758664 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death