BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBRA PZF

    MDR report key: 7926981 · Received October 2, 2018

    Report

    Report Number
    3009306400-2018-00069
    Event Type
    Injury
    Date Received
    October 2, 2018
    Date of Event
    July 4, 2016
    Report Date
    October 2, 2018
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397007219
    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 EVENT OCCURRED APPROXIMATELY 3 MONTHS AFTER INDEX PROCEDURE, THE DELIVERY SYSTEM WAS NOT REQUESTED AS IT WAS LIKELY DISCARDED BY THE SITE. A REVIEW OF THE LOT HISTORY RECORD (LHR) INDICATES THAT THERE ARE NO NON-CONFORMANCES ISSUED TO THIS LOT AND THAT THIS DEVICE MET ITS PRE-DETERMINED SPECIFICATIONS. RESTENOSIS IS LABELED IN THE INSTRUCTIONS FOR USE AS A POSSIBLE ADVERSE EVENT. THE INVESTIGATOR BELIEVES THE EVENT IS NOT RELATED TO THE PROCEDURE OR THE STUDY DEVICE. PER THE SPONSOR, INTRACORONARY STENT RESTENOSIS IS MULTIFACTORIAL; THE PATIENT LESION TYPE, DISEASE PROGRESSION, COMORBIDITIES, AND VESSEL TRAUMA DURING THE INDEX PROCEDURE COULD BE CONTRIBUTING FACTORS, HOWEVER, RELATION TO THE STUDY DEVICE COULD NOT BE EXCLUDED. THE IDENTIFICATION OF RESTENOSIS AT THE SITE OF THE TREATED LESION DOES NOT IMPLY A TECHNICAL PROBLEM WITH 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: WHILE THE MANUFACTURER (CELONOVA BIOSCIENCES) WAS INITIALLY MADE AWARE OF THE ADVERSE EVENT ON (B)(6) 2018, CLARIFICATION OF FDA REGULATION 21 CFR - PART 820.198(A) WAS OBTAINED FROM FDA DIVISION OF INDUSTRY AND CONSUMER EDUCATION (DICE) ON (B)(6) 2018 THAT THIS EVENT SHOULD BE CONSIDERED FOR REPORTABILITY. ON 01 OCTOBER 2018 IS WAS DISCOVERED THAT A MEDICAL DEVICE REPORT (MDR) WAS INADVERTENTLY NOT FILED FOR THIS COMPLAINT BECAUSE THE ORIGINAL (INCORRECT) DECISION TREE WAS VIEWED (WHICH INDICATED THAT THIS EVENT WAS NOT DEVICE RELATED), INSTEAD OF THE REVISED, UPGRADED DECISION TREE (FOR VIGILANCE - EU REPORTING) THAT INDICATED THAT RELATIONSHIP TO DEVICE COULD NOT BE COMPLETELY EXCLUDED. THUS, THIS WILL CONSERVATIVELY BE REPORTED.

    Description of Event or Problem · 1

    AN (B)(6) FEMALE PATIENT PRESENTED WITH MEDICAL HISTORY OF CORONARY ARTERY DISEASE, OBESITY, HYPERCHOLESTEROLEMIA, ISCHEMIC CARDIOMYOPATHY WITH A STENOSIS AT THE LEFT CORONARY COMMON TRUNK (LEFT MAIN) AT 70% (REFUSED ANGIOPLASTY), DUAL CHAMBER PACEMAKER IMPLANTED IN 2011, DYSLIPIDEMIA, AND ARTERIAL HYPERTENSION. ON (B)(6) 2016, THE PATIENT PRESENTED WITH ACUTE HEART FAILURE WITH PULMONARY EDEMA. SHE PLACED ON NON-INVASIVE VENTILATION, AND TRANSFERRED TO INTENSIVE CARE UNIT OF CARDIOLOGY. THERE WAS NO CHEST PAIN. THE INITIAL ELECTROCARDIOGRAPHY (ECG) RECORDED A-FIB WITH COMPLETE LEFT BLOCK AND MANY UNSUPPORTED VT (VENTRICULAR TACHYCARDIA). ECHOCARDIOGRAPHY, SHOWED EJECTION FRACTION WITH 35 %, LATERAL KINESIS AND ANTERIOR HYPOKINESIA. CORONARY ANGIOPLASTY SHOWED SIGNIFICANT STENOSIS (90%) TYPE B1 IN THE OSTIUM OF THE LEFT MAIN, AND SUB-OCCLUSIVE STENOSIS (90-99%) AT THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH TIMI FLOW 2. THE PATIENT ENROLLED IN COBRA TRIAL. PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED VIA RADIAL ACCESS WITH A COBRA PZF¿ (2.5X 12) STENT IMPLANTED IN MID LAD WITHOUT PRE-DILATION, AND A DES STENT IMPLANTED IN OSTIUM OF AT THE LEFT MAIN CORONARY ARTERY. GOOD IMMEDIATE ANGIOGRAPHIC RESULT NOTED WITH COMPLETE REVASCULARIZATION. ON (B)(6) 2016, THE PATIENT PRESENTED WITH CHEST PAIN WITH MODERATE CARDIAC ENZYME ELEVATION WITHOUT ECG CHANGES NOTED. ECHOCARDIOGRAPHY, SHOWED KINETICS STABILITY WITH ANTERO-SEPTO-APICAL AKINESIA AND A 35% EJECTION FRACTION (EF). CORONARY ANGIOGRAPHY, FOR FURTHER EVALUATION, SHOWED SIGNIFICANT (90-99%) INTRA-STENT RESTENOSIS OF THE MID LAD, AND INTERMEDIATE STENOSIS (50%) IN LEFT MAIN CORONARY ARTERY. THE PATIENT WAS TREATED WITH ACTIVE STENTING ANGIOPLASTY AT MID LAD AND STABILIZATION OF THE LEFT MAIN VIA IMPLANTATION OF ANOTHER STENT. ON (B)(6) 2016, THE PATIENT WAS HOSPITALIZED DUE TO PRESENTATION OF RECURRING CHEST PAIN SYMPTOMS. ECG SHOWED NO CHANGES. TROPONIN PEAKED AT 1.1. A DECISION OF MEDICAL TREATMENT ONLY WAS MADE DUE TO THE REMAINING PRE-OCCLUSIVE STENOSIS OF THE 1ST DIAGONAL CORONARY ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766583 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 1504064003 00879397007219

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| R