BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBRA PZF

    MDR report key: 9975550 · Received April 17, 2020

    Report

    Report Number
    3009306400-2020-00007
    Event Type
    Death
    Date Received
    April 17, 2020
    Date of Event
    January 22, 2020
    Report Date
    April 17, 2020
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397007332
    PMA / PMN Number
    P160014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H2 ADDITIONAL INFORMATION: B5 REVISED. H6 REVISED. THE DEVICE WAS REQUESTED, BUT STENT REMAINS IMPLANTED IN PATIENT AND DELIVERY SYSTEM IS PRESUMED DISCARDED. A REVIEW OF THE LOT HISTORY RECORD (LHR) WAS PERFORMED. THERE WERE NO NON-CONFORMANCES. THE LOT CONFORMS TO ITS PREDETERMINED SPECIFICATIONS AND REQUIREMENTS, INCLUDING FOR STENT RETENTION. PLAQUE SHIFT AND DEATH ARE CAPTURED IN THE RISK ASSESSMENT AS KNOWN POTENTIAL HAZARDS AND LISTED IN THE INSTRUCTIONS FOR USE AS KNOWN POTENTIAL ADVERSE EVENTS. THE PRINCIPAL INVESTIGATOR INDICATED THAT THE EVENT IS POSSIBLY RELATED TO INDEX PROCEDURE AND POSSIBLY RELATED TO STUDY DEVICE. WHILE THE EXACT CAUSE OF EVENT IS UNABLE TO BE DETERMINED, PATIENT COMBORBIDITIES AND VESSEL MORPHOLOGY ARE THE MOST PROBABLE CONTRIBUTORS TO THE EVENT. PER THE SPONSOR, THE RELATIONSHIP BETWEEN THE COBRA STENT AND REPORTED ADVERSE EVENTS 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 · 0

    A 75-YEAR-OLD MALE WITH ARTERIAL HYPERTENSION, ACTIVE SMOKER (40 PACK YEARS), DYSLIPIDAEMIA, HISTORY OF PERIPHERAL VASCULAR DISEASE 2018, PERSISTENT ATRIAL FIBRILLATION (2014 AND 2019), OBSTRUCTIVE SLEEP APNEA SYNDROME, A 26MM ABDOMINAL AORTIC ANEURYSM IN 2019, DEPRESSION, RIGHT-SIDED INGUINAL HERNIA, BILATERAL CATARACTS, RETINAL DETACHMENT, LEFT OLECRANON FRACTURE IN 2016, CHRONIC ALCOHOLISM, CHRONIC PANCREATITIS, AND MÉNIÈRE'S DISEASE. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2020 FOR UNSTABLE ANGINA AND AN ELEVATED HIGH SENSITIVE TROPONIN T VALUE OF 0.017 NG/ML. THE PATIENT REPORTED INCREASING ASTHENIA AND DYSPNEA CLASS NYHA III. ELECTROCARDIOGRAPHY (ECG) ON ADMISSION SHOWED SINUS RHYTHM WITH DIFFUSE FLATTENED T-WAVES. THE LAST ECG PERFORMED ON (B)(6) 2020 SHOWED A LEFT VENTRICULAR EJECTION FRACTION (LVEF) OF 65% (IN ATRIAL FIBRILLATION), NO SIGNIFICANT VALVE DISEASE, A DILATED LA, AND SPAP VALUE OF 39 MMHG. CORONARY ANGIOGRAPHY WAS PERFORMED ON (B)(6) 2020 USING THE RIGHT RADIAL APPROACH, WHICH SHOWED 3-VESSEL DISEASE AND 2 LESIONS TO BE STENTED. IT SHOWED 50-70%, SLIGHTLY CALCIFIED, ECCENTRIC TYPE B2 LESION IN THE OSTIUM OF LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH TIMI 3 FLOW, AND 70-90% SEVERELY CALCIFIED TYPE C LESION IN THE MID LAD WITH TIMI 3 FLOW. THE 1ST OBTUSE MARGINAL (OM) SHOWED VERY TIGHT STENOSIS (70-90%), CALCIFIED TYPE B2 LESION WITH TIMI 3 FLOW, AND NO STENOSIS IN THE PROXIMAL CIRCUMFLEX ARTERY. A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED WITH PLACEMENT OF A 2.75X30 MM COBRA PZF¿ STENT IN THE MID LAD, WITH PRE AND POST DILATION. DUE TO AN EDGE DISSECTION TYPE A, A 3X12MM COBRA PZF¿ STENT WAS DEPLOYED. AFTERWARD, A TIMI 3 FLOW WAS NOTED. A THIRD COBRA PZF¿ STENT (3X12MM) WAS PLACED WITHOUT PRE-DILATION IN THE 1ST OM; NO SIGNIFICANT STENOSIS AND A TIMI 3 FLOW IN THE MARGINAL BRANCH WERE REPORTED. HOWEVER, A SUB-OCCLUSIVE PLAQUE-SHIFTING TO THE PROXIMAL CIRCUMFLEX, WITH CONCOMITANT ANGINA PECTORIS AND TIMI 2 FLOW OCCURRED NECESSITATING A DIRECT-STENTING WITH A 2.75X18 MM COBRA PZF¿ STENT IN THE PROXIMAL CIRCUMFLEX CORONARY ARTERY. AFTER THIS STENT IMPLANTATION NO SIGNIFICANT STENOSIS AND A NORMAL CORONARY FLOW WERE REPORTED (TIMI 3). PERI-INTERVENTIONAL ASPIRIN, HEPARIN, CLOPIDOGREL, EPTIFIBATIDE, AND ISOSORBIDE DINITRATE WERE ADMINISTERED. FOLLOWING THE INDEX PCI, WHILE IN WARD, THE PATIENT DEVELOPED ELECTROMECHANICAL DISSOCIATION, REQUIRING RESUSCITATION WITH VERY DIFFICULT INTUBATION (CORMACK GRADE IV, WITH SUSPECTED SUBGLOTTIC STENOSIS), ADRENALINE (CUMULATIVE DOSE 7MG), REPEATED ELECTRICAL CARDIOVERSION (8 SHOCKS BECAUSE OF THE REPEATED INDUCED VENTRICULAR FIBRILLATION), AMIODARONE (450 MG TOTAL), AND MAGNESIUM SULFATE. CARDIORESPIRATORY ARREST DID NOT RESPOND TO TREATMENT DESPITE OVER 40 MINUTES OF RESUSCITATION. DEATH WAS CONFIRMED ON (B)(6) 2020 AT 10:50. THE INVESTIGATOR REPORTED THE EVENT AS POSSIBLY RELATED TO THE PROCEDURE AND DEVICE. AS NO AUTOPSY OR SECOND ANGIOGRAM WAS PERFORMED, A STENT THROMBOSIS CANNOT BE COMPLETELY RULED OUT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED, BUT STENT REMAINS IMPLANTED IN PATIENT AND DELIVERY SYSTEM IS PRESUMED DISCARDED. A REVIEW OF THE LOT HISTORY RECORD (LHR) WAS PERFORMED. THERE WERE NO NON-CONFORMANCES. THE LOT CONFORMS TO ITS PREDETERMINED SPECIFICATIONS AND REQUIREMENTS, INCLUDING FOR STENT RETENTION. PLAQUE SHIFT AND DEATH ARE CAPTURED IN THE RISK ASSESSMENT AS KNOWN POTENTIAL HAZARDS AND LISTED IN THE INSTRUCTIONS FOR USE AS KNOWN POTENTIAL ADVERSE EVENTS. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ADDITIONAL RELEVANT INFORMATION. THE OTHER COBRA PZF STENTS REFERENCED ARE REPORTED UNDER SEPARATE MANUFACTURER REPORT NUMBERS.

    Description of Event or Problem · 1

    A (B)(6) OLD MALE WITH ARTERIAL HYPERTENSION, ACTIVE SMOKER (40 PACK YEARS), DYSLIPIDAEMIA, HISTORY OF PERIPHERAL VASCULAR DISEASE 2018, PERSISTENT ATRIAL FIBRILLATION (2014 AND 2019), OBSTRUCTIVE SLEEP APNEA SYNDROME, A 26MM ABDOMINAL AORTIC ANEURYSM IN 2019, DEPRESSION, RIGHT-SIDED INGUINAL HERNIA, BILATERAL CATARACTS, RETINAL DETACHMENT, LEFT OLECRANON FRACTURE IN 2016, CHRONIC ALCOHOLISM, CHRONIC PANCREATITIS, AND MÉNIÈRE'S DISEASE. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2020 FOR UNSTABLE ANGINA AND AN ELEVATED HIGH SENSITIVE TROPONIN T VALUE OF 0.017 NG/ML. THE PATIENT REPORTED INCREASING ASTHENIA AND DYSPNEA CLASS NYHA III. ELECTROCARDIOGRAPHY (ECG) ON ADMISSION SHOWED SINUS RHYTHM WITH DIFFUSE FLATTENED T-WAVES. THE LAST ECG PERFORMED ON (B)(6) 2020 SHOWED A LEFT VENTRICULAR EJECTION FRACTION (LVEF) OF 65% (IN ATRIAL FIBRILLATION), NO SIGNIFICANT VALVE DISEASE, A DILATED LA, AND SPAP VALUE OF 39 MMHG. CORONARY ANGIOGRAPHY WAS PERFORMED ON (B)(6) 2020 USING THE RIGHT RADIAL APPROACH, WHICH SHOWED 3-VESSEL DISEASE AND 2 LESIONS TO BE STENTED. IT SHOWED 50-70%, SLIGHTLY CALCIFIED, ECCENTRIC TYPE B2 LESION IN THE OSTIUM OF LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH TIMI 3 FLOW, AND 70-90% CALCIFIED TYPE B1 LESION IN THE MID LAD WITH TIMI 3 FLOW. THE 1ST OBTUSE MARGINAL (OM) SHOWED VERY TIGHT STENOSIS (70-90%), CALCIFIED TYPE B1 LESION WITH TIMI 3 FLOW, AND NO STENOSIS IN THE PROXIMAL CIRCUMFLEX ARTERY. A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED WITH PLACEMENT OF A 2.75X30 MM COBRA PZF¿ STENT IN THE MID LAD, WITH PRE AND POST DILATION. DUE TO AN EDGE DISSECTION TYPE A, A 3X12MM COBRA PZF¿ STENT WAS DEPLOYED. AFTERWARD, A TIMI 3 FLOW WAS NOTED. A THIRD COBRA PZF¿ STENT (3X12MM) WAS PLACED WITHOUT PRE-DILATION IN THE 1ST OM; NO SIGNIFICANT STENOSIS AND A TIMI 3 FLOW IN THE MARGINAL BRANCH WERE REPORTED. HOWEVER, A SUB-OCCLUSIVE PLAQUE-SHIFTING TO THE PROXIMAL CIRCUMFLEX, WITH CONCOMITANT ANGINA PECTORIS AND TIMI 2 FLOW OCCURRED NECESSITATING A DIRECT-STENTING WITH A 2.75X18 MM COBRA PZF¿ STENT IN THE PROXIMAL CIRCUMFLEX CORONARY ARTERY. AFTER THIS STENT IMPLANTATION NO SIGNIFICANT STENOSIS AND A NORMAL CORONARY FLOW WERE REPORTED (TIMI 3). PERI-INTERVENTIONAL ASPIRIN, HEPARIN, CLOPIDOGREL, EPTIFIBATIDE, AND ISOSORBIDE DINITRATE WERE ADMINISTERED. FOLLOWING THE INDEX PCI, WHILE IN WARD, THE PATIENT DEVELOPED ELECTROMECHANICAL DISSOCIATION, REQUIRING RESUSCITATION WITH VERY DIFFICULT INTUBATION (CORMACK GRADE IV, WITH SUSPECTED SUBGLOTTIC STENOSIS), ADRENALINE (CUMULATIVE DOSE 7MG), REPEATED ELECTRICAL CARDIOVERSION (8 SHOCKS BECAUSE OF THE REPEATED INDUCED VENTRICULAR FIBRILLATION), AMIODARONE (450 MG TOTAL), AND MAGNESIUM SULFATE. CARDIORESPIRATORY ARREST DID NOT RESPOND TO TREATMENT DESPITE OVER 40 MINUTES OF RESUSCITATION. DEATH WAS CONFIRMED ON (B)(6) 2020 AT 10:50. THE INVESTIGATOR REPORTED THE EVENT AS POSSIBLY RELATED TO THE PROCEDURE AND DEVICE. AS NO AUTOPSY OR SECOND ANGIOGRAM WAS PERFORMED, A STENT THROMBOSIS CANNOT BE COMPLETELY RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438791 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. NA 1904254002 00879397007332

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| R GUIDE CATHETER: LAUNCHER EBU 3.75.| GUIDE WIRE: ABBOTT PORT EXTRA 0.014".| POST-DILATATION BALLOON: MEDTRONIC NC 3.0X8MM.| STENTS: COBRA PZF (2.75X30, 3.0X12, 2.75X18).