BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBRA PZF

    MDR report key: 7791515 · Received August 16, 2018

    Report

    Report Number
    3009306400-2018-00042
    Event Type
    Death
    Date Received
    August 16, 2018
    Date of Event
    September 17, 2016
    Report Date
    August 16, 2018
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397007400
    PMA / PMN Number
    160014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ESTABLISHMENT NAME IS: (B)(6) HOSPITAL (B)(6). AS THE STENT REMAINS IMPLANTED IN THE PATIENT AND THE EVENT OCCURRED MORE THAN TWO YEARS AFTER THE INDEX PROCEDURE, THE DEVICE WAS NOT REQUESTED FOR RETURN. A REVIEW OF THE LOT HISTORY RECORD (LHR) WAS PERFORMED. THERE WERE NO NON-CONFORMANCES. THE DEVICES FROM THIS LOT CONFORMS TO THEIR PREDETERMINED SPECIFICATIONS AND REQUIREMENTS. MYOCARDIAL INFARCTION, THROMBOSIS, AND DEATH ARE LISTED IN THE COBRA PZF INSTRUCTIONS FOR USE AS KNOWN POTENTIAL ADVERSE EVENTS. RISK ASSESSMENT REVIEW CONFIRMED THAT THROMBOSIS IS CAPTURED AS A POTENTIAL HARM; STENT THROMBOSIS CAN OCCUR DUE TO STENT SURFACE REACTIVITY INCREASES, VESSEL AREA OUTSIDE IS DAMAGED, STENT NOT FULLY EXPANDED TO VESSEL WALL, STENT IS EXPANDED BEYOND DESIGN INTENT, STENT IS OVERSTRESSED LEADING TO FRACTURE, STENT MIGRATES FROM ORIGINAL POSITION, STENT IS THROMBOGENIC. IN THIS CASE, THE INVESTIGATOR'S ASSESSMENT OF THE EVENT IS POSSIBLE STENT THROMBOSIS, POSSIBLY RELATED TO THE STUDY DEVICE OR STUDY 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. AWARE DATE NOTE: CELONOVA BIOSCIENCES WAS INITIALLY MADE AWARE OF THIS EVENT ON (B)(6)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 ((B)(6) 2018) THAT THE EVENT SHOULD BE CONSERVATIVELY REPORTED.

    Description of Event or Problem · 1

    PER THE MEDICAL AFFAIRS' ASSESSMENT: A (B)(6) YEAR OLD FEMALE WITH HISTORY OF STROKE, DIABETES, HYPERTENSION, HYPERLIPEMIA, AND HEART FAILURE PRESENTED WITH STABLE ANGINA IN (B)(6) 2014. ANGIOGRAPHY SHOWED 90% STENOSIS OF PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH A TYPE A LESION. PATIENT WAS ENROLLED IN THE COBRA SHIELD STUDY AND UNDERWENT STENT IMPLANTATION (3.5X15MM COBRA PZF NANOCOATED STENT) AFTER PRE-DILATION. POST PROCEDURE THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI) FLOW WAS 3. LATER ON PATIENT HAD EXPERIENCED ISCHEMIC SYMPTOMS UNRELATED TO THE STUDY. FOLLOW UP AT 9 MONTHS REPORTED 75% MID RCA STENOSIS WITH PERCUTANEOUS CORONARY INTERVENTION (PCI) UNRELATED TO THE STUDY PROCEDURE AND DEVICE. ON (B)(6) 2016, ACCORDING TO PATIENT'S DAUGHTER, THE PATIENT EXPERIENCED SEVERAL DAYS OF ONGOING CHEST PAIN, DID NOT SEEK MEDICAL ATTENTION AND WAS FOUND DEAD ((B)(6) 2016) AT HOME. THE DAUGHTER REPORTED THAT THE AUTOPSY REPORT INDICATED SEVERE MYOCARDIAL INFARCTION (MI) THAT RESULTED IN HER DEATH. THE SPONSOR HAS NOT RECEIVED THE AUTOPSY REPORT AT THE TIME OF THIS REPORT. THE SPONSOR RECEIVED THE DEATH CERTIFICATE WHICH STATED ACUTE MYOCARDIAL INFARCTION AS THE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630115 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 1303154002 00879397007400

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death