BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBRA PZF

    MDR report key: 8066510 · Received November 13, 2018

    Report

    Report Number
    3009306400-2018-00076
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    September 3, 2018
    Report Date
    November 13, 2018
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397000562
    PMA / PMN Number
    160014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). AS THE STENT REMAINS IMPLANTED IN THE PATIENT AND THE EVENT OCCURRED SEVERAL MONTHS 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 RESTENOSIS IS CAPTURED AS A FORESEEABLE EVENT. A REVIEW OF COBRA PZF INSTRUCTIONS FOR USE (IFU) WAS CONDUCTED. RESTENOSIS, ANGINA, AND NAUSEA ARE LISTED IN THE IFU AS KNOWN POTENTIAL ADVERSE EVENTS. A REVIEW OF BOTH INDEX PROCEDURE AND INTERVENTION ANGIOGRAPHY IMAGES FOR SITE 9900, PATIENT 007 WAS CONDUCTED BY CELONOVA MEDICAL AFFAIRS. THE INCIDENCE OF IN-STENT RESTENOSIS (ISR) IS CONFORMED AND A GOOD STENT EXPANSION WITH TREATMENT NOTED. THE INVESTIGATOR CONSIDERED THE RESTENOSIS AS NOT RELATED TO THE INDEX PROCEDURE, BUT POSSIBLY RELATED TO THE STUDY DEVICE. INTRACORONARY STENT RESTENOSIS IS MULTIFACTORIAL (INCLUDING, BUT NOT LIMITED TO, PATIENT LESION TYPE, DISEASE PROGRESSION, COMORBIDITIES, AND VESSEL TRAUMA DURING THE INDEX PROCEDURE). RESTENOSIS CAN ALSO RESULT FROM MALPOSITION OF THE STENT/SUB-OPTIMAL STENT EXPANSION (STENT UNABLE TO MAINTAIN INTENDED PATENCY, LOSS OF STRENGTH DUE TO FRACTURE, POSITION OF STENT COMPROMISED, USE ERROR OF INCORRECT DEPLOYMENT, SMALLER DEPLOYED DIAMETER). IN THIS CASE, PATIENT COMORBIDITIES AND DISEASE PROGRESSION ARE LIKELY CONTRIBUTORY FACTORS TO THE REPORTED EVENTS. HOWEVER, PER THE SPONSOR, THE RELATIONSHIP OF THE SATELLITE SYMPTOMS AND RESTENOSIS TO STUDY DEVICE COULD NOT BE COMPLETELY 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.

    Description of Event or Problem · 1

    A (B)(6)-YEAR-OLD FEMALE WITH MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD), ATRIAL FIBRILLATION ON ELIQUIS, HEART FAILURE WITH REDUCED EJECTION FRACTION WITH EF= 40%, STROKE, HYPERTENSION, AND DYSLIPIDEMIA, PRESENTED WITH NON-ST-ELEVATED MYOCARDIAL INFARCTION (NSTEMI) ON (B)(6) 2018. CORONARY ANGIOGRAPHY SHOWED A MODERATELY CALCIFIED TYPE B2, 55% STENOSED LESION IN THE MILDLY TORTUOUS MID LEFT ANTERIOR DESCENDING (MLAD) CORONARY ARTERY. THE PATIENT ENROLLED IN THE COBRA TRIAL. AFTER PRE-DILATING THE LESION, A COBRA PZF NANOCOATED STENT (4.0X18MM) WAS ADVANCED VIA RADIAL ACCESS AND WAS SUCCESSFULLY IMPLANTED IN THE MLAD, REDUCING STENOSIS TO 20% WITHOUT ANY COMPLICATION. THE PATIENT HAD INTERMITTENT CHEST PAIN WITH MULTIPLE EMERGENCY DEPARTMENT VISITS. EACH OF THESE EVALUATIONS WAS NEGATIVE. NO STRESS TEST PERFORMED OR CARDIAC CATHETERIZATION. EACH OF THESE EPISODES WAS TREATED MEDICALLY WITHOUT INTERVENTION. PER THE INVESTIGATOR, THE CHEST PAIN WAS UNRELATED TO INDEX PROCEDURE AND UNRELATED TO STUDY DEVICE. ON (B)(6) 2018, THE PATIENT PRESENTED WITH CHEST DISCOMFORT FOR THE PAST WEEK; THE PAIN WAS MILD, INTERMITTENT, AND NOT SHARP OR RADIATING, AND ASSOCIATED WITH PALPITATION. THE ELECTROCARDIOGRAM (ECG), AND CARDIAC ENZYMES WERE NORMAL. MYOCARDIAL PERFUSION IMAGING (MPI), SHOWED NORMAL STRESS PERFUSION. NO MEDICATION WAS CHANGED, AND THE PATIENT SCHEDULED FOLLOW-UP WITH CARDIOLOGY. THE INVESTIGATOR DEEMED THIS EVENT AS UNRELATED TO INDEX PROCEDURE, BUT POSSIBLY RELATED TO STUDY DEVICE. DUE TO THE NATURE OF THE PAIN, TIMING, AND ITS MULTIPLE OCCURRENCES AFTER THE INDEX PROCEDURE, THE SPONSOR BELIEVES THAT CHEST DISCOMFORT IS POSSIBLY RELATED TO THE STUDY DEVICE AND THE PROCEDURE. THE PATIENT PRESENTED ON (B)(6) 2018 WITH ATRIAL FIBRILLATION AND INCREASED SHORTNESS OF BREATH. A CORONARY ANGIOGRAPHY PERFORMED ON (B)(6) 2018 FOR FURTHER EVALUATION, SHOWED A FOCAL 60-70% ECCENTRIC IN-STENT RESTENOSIS (ISR) IN THE MID LAD STENT. DISTAL TO STENT IS A 60-70% STENOSIS BRACKETING THE D3. DISTALLY, LAD IS ANGIOGRAPHICALLY NORMAL. D1 IS PATENT WITH MID 35% STENOSIS, TREATED WITH BALLOON ANGIOPLASTY. GOOD STENT EXPANSION APPOSITION WAS NOTED WITH LESS THAN 10% RESIDUAL STENOSIS WITH FRACTIONAL FLOW RESERVE (FFR) OF 0.82 FOR THE LAD. THE PATIENT WAS DISCHARGED (B)(6) 2018 WITH NO ADVERSE SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904026 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 1702144002 00879397000562

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention