BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBRA PZF

    MDR report key: 7827843 · Received August 29, 2018

    Report

    Report Number
    3009306400-2018-00035
    Event Type
    Death
    Date Received
    August 29, 2018
    Date of Event
    October 20, 2017
    Report Date
    February 11, 2020
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397000432
    PMA / PMN Number
    P160014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H2 CORRECTION: G3 REVISED (STUDY BOX CHECKED). H2 ADDITIONAL INFORMATION ADDED TO B5.

    Description of Event or Problem · 0

    IT WAS INITIALLY REPORTED THAT THE INVESTIGATOR DEEMED THE DEATH EVENT AS POSSIBLY RELATED TO BOTH INDEX PROCEDURE AND STUDY DEVICE. ON 29JAN2020, THE SPONSOR WAS NOTIFIED THAT THE INVESTIGATOR NOW DEEMS THE DEATH EVENT AS NOT RELATED TO INDEX PROCEDURE, BUT REMAINS POSSIBLY RELATED TO STUDY DEVICE, AS INITIALLY REPORTED. THE SPONSOR DEEMS DEATH EVENT AS NOT RELATED TO INDEX PROCEDURE AND NOT RELATED TO STUDY DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IMPLANTED IN THE PATIENT. THE DELIVERY SYSTEM WAS USED MORE THREE YEARS PRIOR TO EVENT; THUS, IT WAS NOT REQUESTED FOR RETURN. A REVIEW OF THE LOT HISTORY RECORD (LHR) WAS PERFORMED. THERE WERE NO NON-CONFORMANCES OBSERVED RELATED TO THE REPORTED EVENT FOR THIS LOT. THE LOT CONFORMS TO ITS PREDETERMINED SPECIFICATIONS AND REQUIREMENTS. DEATH IS LISTED IN THE INSTRUCTIONS FOR USE (COBRA PZF) AS LABELED POTENTIAL ADVERSE EVENTS. PATIENT COMORBIDITIES (DIABETES MELLITUS, HYPERTENSION, HYPERLIPIDEMIA, SYSTEMIC LUPUS ERYTHEMATOSUS, AND PERIPHERAL VASCULAR DISEASE) ARE LIKELY CONTRIBUTING FACTORS TO PATIENT'S DEATH, AND THE CAUSE OF DEATH WAS REPORTEDLY DUE TO NATURAL CAUSES. ADDITIONALLY, NO CARDIAC SYMPTOMS HAD BEEN REPORTED SINCE THE INDEX PROCEDURE (B)(6) 2014. HOWEVER, RELATEDNESS TO THE DEVICE COULD NOT BE COMPLETELY RULED OUT, DUE TO THE ABSENCE OF SOURCE DOCUMENTS, AUTOPSY REPORT, AND ANY ADDITIONAL CIRCUMSTANCES SURROUNDING THE DEATH. IN THIS CASE, NO PRODUCT MALFUNCTION, FAILURE OR DETERIORATION OF CHARACTERISTIC OR PERFORMANCE OF THE DEVICE, OR INADEQUACY IN THE LABELING AND/OR INSTRUCTIONS FOR USE WAS IDENTIFIED. 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

    A (B)(6) FEMALE WITH A MEDICAL HISTORY OF CORONARY ARTERY DISEASE, BILATERAL SEVERE PERIPHERAL VASCULAR DISEASE TREATED WITH LASER ATHERECTOMY AND BALLOON ANGIOPLASTY, DIABETES MELLITUS, HYPERTENSION , HYPERLIPIDEMIA ,SYSTEMIC LUPUS ERYTHEMATOSUS, AND A PRIOR SMOKER PRESENTED ON (B)(6) 2014 WITH UNSTABLE ANGINA. THE PATIENT ENROLLED IN COBRA PZF SHIELD TRIAL, AFTER AN ANGIOGRAPHY SHOWED A 90% STENOSED TYPE C LESION IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) CORONARY ARTERY. PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED WITH A 3.0X15MM COBRA PZF NANOCOATED STENT DEPLOYED AT 16 ATMOSPHERES, FOLLOWED BY POST-DILATATION. THE PROCEDURE WAS CONCLUDED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. ON (B)(6) 2016, THE PATIENT EXPERIENCED WORSENING LEFT LEG EDEMA THAT WAS UNABLE TO BE RESOLVED WITH MEDICATION. THE INVESTIGATOR INDICATED THAT THE EDEMA WAS UNRELATED TO THE STUDY DEVICE OR THE INDEX PROCEDURE. ON (B)(6) 2017, THE PATIENT EXPIRED WHILE SLEEPING AT HOME; THE CAUSE OF DEATH WAS DETERMINED BY A MEDICAL EXAMINER TO BE DUE TO NATURAL CAUSES PER PATIENT'S SPOUSE. THE STUDY TEAM WAS NOTIFIED ON 3 AUGUST 2018 BY THE PATIENT'S SPOUSE. NO AUTOPSY WAS DONE. PER THE INVESTIGATOR, RELATIONSHIP OF DEATH TO THE INDEX PROCEDURE AND STUDY DEVICE CAN NOT BE EXCLUDED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671469 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 1403194001 00879397000432

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death