BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBRA PZF

    MDR report key: 11802376 · Received May 10, 2021

    Report

    Report Number
    3009306400-2021-00003
    Event Type
    Injury
    Date Received
    May 10, 2021
    Date of Event
    January 9, 2021
    Report Date
    May 10, 2021
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397000876
    PMA / PMN Number
    P160014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IMPLANTED IN PATIENT AND THERE WAS NO REPORTED DELIVERY SYSTEM MALFUNCTION; THUS, THE DELIVERY SYSTEM IS PRESUMED DISCARDED AND WAS NOT REQUESTED. A REVIEW OF THE LOT HISTORY RECORD (LHR) REVEALED NO NON-CONFORMANCES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE THROMBOSIS EVENT. THE DEVICES FROM THIS LOT CONFORM TO THEIR PREDETERMINED SPECIFICATIONS AND REQUIREMENTS. A RISK ASSESSMENT REVIEW INDICATES THAT THROMBOSIS IS CAPTURED AS A FORESEEABLE EVENT. A REVIEW OF INSTRUCTIONS FOR USE (IFU) WAS CONDUCTED. THROMBOSIS IS LABELED IN THIS IFU AS A POTENTIAL ADVERSE EVENT. CAUSES OF STENT THROMBOSIS CAN BE MULTI-FACTORIAL AND CAN INCLUDE PATIENT MEDICAL HISTORY AND COMORBIDITIES; NOT RESPONSIVE TO (OR COMPLIANT WITH) PRESCRIBED ANTIPLATELET THERAPY; VESSEL MORPHOLOGY; THROMBOGENIC VESSELS; INCREASE IN STENT SURFACE REACTIVITY; STENT THROMBOGENIC FOR PATIENT; STENT DAMAGED; STENT EXPANDED BEYOND DESIGN INTENT; STENT OVERSTRESSED LEADING TO FRACTURE, STENT IS UNDER-EXPANDED. IN THIS CASE, WHILE THE MOST PROBABLE CAUSE OF THROMBOSIS MAY BE ATTRIBUTED TO PATIENT COMORBIDITIES AND ANATOMICAL MORPHOLOGY (ED PRESENTATION OF CARDIAC ARREST AND SUSPECTED POOR RESPONSE TO ANTI-PLATELET MEDICATION), POSSIBLE RELATIONSHIP TO THE COBRA STENT (IMPLANTED (B)(6) 2021) 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 · 1

    ON (B)(6) 2021, A (B)(6)-YEAR-OLD MALE PATIENT WITH SEVERE BRADYCARDIA, HYPERTENSION, HYPERLIPIDEMIA, CHRONIC ATRIAL FIBRILLATION, UNDER CARDIAC ARREST AND RECEIVING CARDIOPULMONARY RESUSCITATION (CPR), PRESENTED TO EMERGENCY DEPARTMENT (ED). AFTER 15 TO 20 MINUTES OF CPR AND 6 SHOCKS, RETURN OF SPONTANEOUS CIRCULATION (ROSC) WAS ACHIEVED. THE PATIENT WAS STARTED ON PRESSORS AND HEPARIN, GIVEN EXTERNAL PACEMAKER, WAS SEDATED, INTUBATED, AND VENTILATED. DIAGNOSTIC ANGIOGRAPHY SHOWED 90% CALCIFIED LESION IN A POSTEROLATERAL ARTERIAL BRANCH (PLB) AND 80% CALCIFIED LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA) (DOMINANT). A TEMPORARY INTERNAL PACEMAKER WAS IMPLANTED THEN THE LESIONS WERE PRE-DILATED WITH A 2.5X15MM BALLOON. AS THE PATIENT WAS AT HIGH RISK FOR BLEEDING FOR BEING ON ELIQUIS, ANTICOAGULANT MEDICATION, FOR THE CHRONIC ATRIAL FIBRILLATION, COBRA PZF¿ NANOCOATED STENTS WERE SELECTED FOR TREATMENT OF THE LESIONS. USING A GUIDELINER SUPPORT CATHETER (SIZE UNKNOWN), TWO OVERLAPPING COBRA PZF¿ NANOCOATED CORONARY STENTS (3.5X24MM AND 3.5X15MM) WERE DEPLOYED IN THE DISTAL RCA AND PLB LESIONS AT 10 ATMOSPHERES (ATMS) AND POST-DILATED TO 13 ATMS WITHOUT COMPLICATION, RESULTING IN TIMI 3 FLOW AND SATISFACTORY RESULT. POST-PROCEDURE, PATIENT WAS GIVEN A LOADING DOSE OF ANTI-PLATELET THERAPY (PLAVIX AND ASA (ASPIRIN)), THEN TRANSFERRED TO ICU IN STABLE CONDITION. ON (B)(6) 2021, WHILE STILL INTUBATED, THE PATIENT RETURNED TO THE CATH LAB WITH ST-ELEVATED MYOCARDIAL INFARCTION (STEMI). THE RCA HAD NO FLOW IN THE DISTAL STENT WITH 100% OCCLUSION DUE TO THROMBUS. ANGIOPLASTY WAS PERFORMED IN THE TWO COBRA STENTS WITH A 2.5MM BALLOON, RESTORING TIMI 2 FLOW. ADDITIONAL UNCOVERED, DE NOVO STENOSIS (95%) WAS NOTED IN THE MID TO DISTAL RCA. A 3RD COBRA PZF¿ NANOCOATED CORONARY STENT (4.0X24MM) WAS DEPLOYED IN MID TO DISTAL RCA, PROXIMAL TO (NOT OVERLAPPING) THE PREVIOUSLY IMPLANTED COBRA STENTS (IN (B)(6) 2021 INDEX PROCEDURE), FOLLOWED BY POST-DILATATION OF ALL THREE STENTS WITH A 4.0X15MM BALLOON TO ENSURE OPTIMAL EXPANSION. THE PROCEDURE WAS CONCLUDED WITH GOOD RESULT (BRISK DISTAL TIMI 3 FLOW WITH NO SIGNIFICANT RESIDUAL THROMBUS). PATIENT WAS TRANSFERRED BACK TO ICU IN CRITICAL CONDITION. AS THE PHYSICIAN WAS UNDER THE IMPRESSION THAT THE PATIENT WAS NOT RESPONDING TO PREVIOUSLY ADMINISTERED PLAVIX, THE PHYSICIAN DECIDED TO REPLACE PLAVIX WITH EFFICIENT AFTER THIS 2ND PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695227 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. NA 1909254002 00879397000876

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention