BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBRA PZF

    MDR report key: 10437783 · Received August 21, 2020

    Report

    Report Number
    3009306400-2020-00024
    Event Type
    Death
    Date Received
    August 21, 2020
    Date of Event
    August 7, 2020
    Report Date
    October 26, 2020
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397007295
    PMA / PMN Number
    P160014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H2 ADDITIONAL INFORMATION: B5 REVISED. H6 CODING REVISED. PLEASE NOTE THAT H6 HEALTH EFFECT IMPACT CODE WAS NOT ABLE TO BE ADDED. THIS CODE SHOULD BE 1802. AS THE STENT WAS IMPLANTED 5 MONTHS AGO AND THERE IS NO REPORT OF ANY DEVICE ISSUE, THE DEVICE WAS NOT REQUESTED. A REVIEW OF THE LOT HISTORY RECORD (LHR) WAS PERFORMED. THERE WERE NO NON-CONFORMANCES. THE LOT CONFORMS TO ITS PREDETERMINED SPECIFICATIONS AND REQUIREMENTS. DEATH IS CAPTURED IN THE RISK ASSESSMENT AS A KNOWN POTENTIAL HARM AND LISTED IN THE INSTRUCTIONS FOR USE AS KNOWN POTENTIAL ADVERSE EVENT. THE PRINCIPAL INVESTIGATOR INDICATED THAT THE EVENT IS POSSIBLY RELATED TO INDEX PROCEDURE AND POSSIBLY RELATED TO STUDY DEVICE. WHILE THE EXACT CAUSE OF EVENT IS UNABLE TO BE DETERMINED, PATIENT COMBORBIDITIES AND VESSEL MORPHOLOGY ARE THE MOST PROBABLE CONTRIBUTORS TO THE EVENT. PER THE SPONSOR, IN THE ABSENCE OF AN AUTOPSY, CAUSE OF DEATH, OR OTHER ADDITIONAL INFORMATION, A RELATIONSHIP BETWEEN THE COBRA STENT AND REPORTED ADVERSE EVENT CANNOT BE COMPLETELY EXCLUDED. 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 · 0

    AN 88-YEAR-OLD MALE WITH A MEDICAL HISTORY OF CORONARY ARTERY DISEASE WITH PRIOR PERCUTANEOUS CORONARY ARTERY (PCI) IN 2013, ATRIAL FIBRILLATION ON APIXABAN, TYPE II DIABETES MELLITUS, HYPERTENSION, DYSLIPIDEMIA, PERIPHERAL VASCULAR DISEASE, PRESENTED WITH NON-ST-ELEVATED MYOCARDIAL INFARCTION (NSTEMI). THE PATIENT ENROLLED IN A COBRA STUDY. THE PATIENT SHOWED TYPE B1 LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. ON (B)(6) 2020, AFTER PRE-DILATION, A 2.75X18MM COBRA PZF¿NANOCAOTED STENT WAS DEPLOYED WITH GOOD ANGIOGRAPHIC RESULTS AND WITHOUT COMPLICATION. NO ADVERSE EVENTS REPORTED DURING THE 30-DAY FOLLOW-UP. THE PATIENT WAS COMPLIANT WITH HIS MEDICATION. ON (B)(6) 2020 (APPROXIMATELY 10 WEEKS AFTER PCI), RELATIVES DISCOVERED THAT THE PATIENT HAD DECEASED IN HIS SLEEP AT HOME DUE TO AN UNKNOWN CAUSE. REPORTEDLY, NO AUTOPSY WAS PERFORMED DUE TO ADVANCED AGE, AS DEATH WAS EXPECTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. PER THE INVESTIGATOR, THE EVENT IS POSSIBLY RELATED TO THE INDEX PROCEDURE AND POSSIBLY RELATED TO STUDY DEVICE. PER THE SPONSOR, WHILE THE EXACT CAUSE OF EVENT IS UNABLE TO BE DETERMINED, PATIENT COMBORBIDITIES ARE THE MOST PROBABLE CONTRIBUTORS TO THE EVENT. IN THE ABSENCE OF AN AUTOPSY, OR CORONARY ANGIOGRAPHIC IMAGING, CAUSE OF THIS UNATTENDED DEATH, A RELATIONSHIP BETWEEN THE COBRA STENT AND REPORTED ADVERSE EVENT CANNOT BE COMPLETELY EXCLUDED.

    Additional Manufacturer Narrative · 1

    AS THE STENT WAS IMPLANTED MORE THAN A YEAR AGO AND THERE IS NO REPORT OF ANY DEVICE ISSUE, THE DEVICE WAS NOT REQUESTED. A REVIEW OF THE LOT HISTORY RECORD (LHR) WAS PERFORMED. THERE WERE NO NON-CONFORMANCES. THE LOT CONFORMS TO ITS PREDETERMINED SPECIFICATIONS AND REQUIREMENTS. A REVIEW OF INSTRUCTIONS FOR USE CONFIRMED THAT DEATH IS LABELED AS A KNOWN POTENTIAL ADVERSE EVENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH RELEVANT ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    AN (B)(6)-YEAR-OLD MALE WITH A MEDICAL HISTORY OF CORONARY ARTERY DISEASE WITH PRIOR PERCUTANEOUS CORONARY ARTERY (PCI) IN 2013, ATRIAL FIBRILLATION ON APIXABAN, TYPE II DIABETES MELLITUS, HYPERTENSION, DYSLIPIDEMIA, PERIPHERAL VASCULAR DISEASE, ATRIAL FIBRILLATION, PRESENTED WITH NON-ST-ELEVATED MYOCARDIAL INFARCTION (NSTEMI). THE PATIENT ENROLLED IN A COBRA STUDY. THE PATIENT SHOWED TYPE B1 LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. AFTER PRE-DILATION, A 2.75X18MM COBRA PZF¿NANOCAOTED STENT WAS DEPLOYED WITH GOOD ANGIOGRAPHIC RESULTS AND WITHOUT COMPLICATION NO ADVERSE EVENTS REPORTED DURING THE 30-DAY FOLLOW-UP. THE PATIENT WAS COMPLIANT WITH HIS MEDICATION. ON (B)(6) 2020 (APPROXIMATELY 10 WEEKS AFTER PCI), RELATIVES DISCOVERED THAT THE PATIENT HAD DECEASED IN HIS SLEEP AT HOME DUE TO AN UNKNOWN CAUSE. REPORTEDLY, NO AUTOPSY WAS PERFORMED DUE TO ADVANCED AGE, AS DEATH WAS EXPECTED. PER THE INVESTIGATOR, THE EVENT IS POSSIBLY RELATED TO THE INDEX PROCEDURE AND POSSIBLY RELATED TO STUDY DEVICE. PER THE SPONSOR, DUE TO THE ABSENCE OF AUTOPSY, THE POSSIBILITY OF DEVICE RELATED EVENT CANNOT BE RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903689 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. NA 1812124003 00879397007295

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death