BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBRA PZF

    MDR report key: 7801508 · Received August 21, 2018

    Report

    Report Number
    3009306400-2018-00055
    Event Type
    Death
    Date Received
    August 21, 2018
    Date of Event
    February 4, 2017
    Report Date
    August 21, 2018
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397007226
    PMA / PMN Number
    160014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATES ARE ESTIMATED. AS THE STENT WAS IMPLANTED 12 MONTHS PRIOR TO THE EVENT, AND THERE WAS NO COMPLAINT AGAINST ITS DELIVERY SYSTEM, THE DEVICE WAS NOT REQUESTED FOR RETURN. A REVIEW OF THE LOT HISTORY RECORD (LHR) WAS PERFORMED. THERE WERE NO NON-CONFORMANCES OBSERVED RELATED TO THIS LOT, INDICATING THAT THE DEVICES FROM THIS SAME LOT CONFORM TO THEIR PREDETERMINED SPECIFICATIONS AND REQUIREMENTS. DEATH IS LABELED IN THE COBRA PZF INSTRUCTIONS FOR USE AS A KNOWN POTENTIAL ADVERSE EVENT. THE INVESTIGATOR REPORTED THAT THE EVENT IS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. WHILE ADVANCED AGE AND OTHER COMORBIDITIES MAY BE A CONTRIBUTING FACTOR TO CARDIAC DEATH, THE RELATEDNESS TO THE DEVICE COULD NOT BE COMPLETELY RULED OUT, DUE TO THE ABSENCE OF AUTOPSY AND ANY ADDITIONAL CIRCUMSTANCES SURROUNDING THE DEATH. 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 (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.

    Additional Manufacturer Narrative · 1

    CORRECTION: ADDED.

    Description of Event or Problem · 1

    A (B)(6) FEMALE WITH MEDICAL HISTORY OF DIABETES MELLITUS (DM) TYPE 2 AND SUPRAVENTRICULAR TACHYCARDIA (SVT) WAS ADMITTED TO HOSPITAL ON (B)(6) 2016 FOR DIAGNOSTIC CORONARY ANGIOGRAPHY. THE CATHETERIZATION DONE ON (B)(6) 2016 SHOWED A DISTAL RIGHT CORONARY ARTERY (RCA) WITH SIGNIFICANTLY STENOSED, TYPE B2 LESION. PATIENT WAS ENROLLED IN COBRA TRIAL. PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED WITH COBRA PZF STENT (2.5X15MM) DEPLOYED ((B)(6) 2016) IN THE DISTAL RCA WITHOUT PRE-DILATATION, WITH TIMI 3 FLOW NOTED. THE PATIENT WAS DISCHARGED THE NEXT DAY WITHOUT ANY COMPLICATION. DURING THE 12-MONTH FOLLOW-UP PHONE CALL, THE PATIENT'S FAMILY REPORTED THAT THE PATIENT DIED AT HOME DURING THE WEEKEND OF (B)(6) 2017 THROUGH (B)(6) 2017( EXACT DATE UNKNOWN) OF POSSIBLE CARDIAC ARREST. THE EXACT CAUSE OF DEATH AND ANY ADDITIONAL INFORMATION WAS UNABLE TO BE OBTAINED.

    Description of Event or Problem · 1

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643408 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. N/A 00879397007226

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death GUIDE WIRE: ASAHI SION BLUE J