BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBRA PZF

    MDR report key: 8192231 · Received December 21, 2018

    Report

    Report Number
    3009306400-2018-00081
    Event Type
    Injury
    Date Received
    December 21, 2018
    Date of Event
    January 1, 2018
    Report Date
    December 21, 2018
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397007233
    PMA / PMN Number
    160014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IMPLANTED IN THE PATIENT. AS THE EVENTS OCCURRED APPROXIMATELY 6 WEEKS, THEN A YEAR AFTER THE INDEX PROCEDURE, THE DELIVERY SYSTEM WAS NOT REQUESTED FOR RETURN. A REVIEW OF THE LOT HISTORY RECORD (LHR) INDICATED THAT THERE WERE NO NON-CONFORMANCES OBSERVED FOR THIS LOT AND THE LOT CONFORMS TO ITS PREDETERMINED SPECIFICATIONS AND REQUIREMENTS. A RISK ASSESSMENT REVIEW INDICATES THAT ISCHEMIA AND RESTENOSIS ARE CAPTURED AS FORESEEABLE EVENTS. A REVIEW OF COBRA PZF INSTRUCTIONS FOR USE (IFU) WAS CONDUCTED. ANGINA, ISCHEMIA, AND RESTENOSIS, ARE LISTED IN THE IFU AS KNOWN POTENTIAL ADVERSE EVENTS. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORTED WITH RELEVANT ADDITIONAL INFORMATION WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT WITH MEDICAL HISTORY OF CORONARY ARTERY DISEASE WITH PERCUTANEOUS CORONARY INTERVENTION (PCI) ON (B)(6) 2015, NYHA CLASS II TO III HEART FAILURE, DIABETES MELLITUS TYPE 2, HYPERTENSION, AND DYSLIPIDEMIA PRESENTED ON (B)(6) 2017 WITH EVIDENCE OF MYOCARDIAL ISCHEMIA. THE PATIENT ENROLLED IN COBRA TRIAL ON (B)(6) 2017 AND UNDERWENT PCI WITH OF COBRA PZF (2.5X 18) STENT IMPLANTED IN THE FIRST DIAGONAL ARTERY. TIMI FLOW WAS 3 AFTER THE PROCEDURE WITH LESS THAN 20% RESIDUAL STENOSIS. APPROXIMATELY SIX WEEKS AFTER THE PROCEDURE (B)(6) 2018), THE PATIENT PRESENTED WITH STABLE ANGINA SYMPTOMS. THE INVESTIGATOR BELIEVED THE EVENT WAS MODERATE IN INTENSITY, POSSIBLY RELATED TO THE DEVICE AND TO THE PROCEDURE. THE PATIENT WAS TREATED WITH MEDICATION AND THE EVENT WAS NOT RESOLVED YET. APPROXIMATELY ONE YEAR (B)(6) 2018) AFTER THE PROCEDURE, THE PATIENT WAS EVALUATED WITH DOBUTAMINE STRESS ECHOCARDIOGRAM, WHICH REVEALED INFERIOR SILENT ISCHEMIA. CORONARY ANGIOGRAPHY FOR FURTHER EVALUATION WAS PERFORMED (B)(6) 2018) AND SHOWED A VERY TIGHT RESTENOSIS (70-90%) AT THE FIRST DIAGONAL BRANCH; CORONARY HAD NORMAL TIMI 3 FLOW. ALSO, THE POSTERIOR DESCENDING ARTERY SHOWED VERY TIGHT STENOSIS (70-90%), WITH HIGHLY CALCIFIED TYPE B1 LESION. THE PATIENT WAS TREATED CONSERVATIVELY WITH MEDICAL MANAGEMENT AND SEND TO A CARDIAC REHABILITATION CENTER. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031191 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 1612084001 00879397007233

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention