BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBRA PZF

    MDR report key: 8642699 · Received May 24, 2019

    Report

    Report Number
    3009306400-2019-00026
    Event Type
    Death
    Date Received
    May 24, 2019
    Date of Event
    December 24, 2018
    Report Date
    March 31, 2020
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    0087939700678
    PMA / PMN Number
    P160014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H2 ADDITIONAL INFORMATION: B5 REVISED. H10 REVISED (BELOW): STENT REMAINS IMPLANTED IN PATIENT. AS EVENT OCCURRED APPROXIMATELY 4 YEARS AFTER INDEX PROCEDURE AND THERE WERE NO REPORTED DEVICE MALFUNCTIONS, THE DELIVERY SYSTEM IS PRESUMED DISCARDED AND WILL NOT BE REQUESTED. A REVIEW OF THE LOT HISTORY RECORD (LHR) INDICATED THAT THERE WERE NO NON-CONFORMANCES RELATED TO THE REPORTED ADVERSE EVENT. THE LOT CONFORMS TO ITS PREDETERMINED SPECIFICATIONS AND REQUIREMENTS. A REVIEW OF COBRA PZF INSTRUCTIONS FOR USE (IFU) WAS CONDUCTED. MYOCARDIAL INFARCTION, STROKE, AND DEATH ARE LABELED IN THE IFU AS KNOWN POTENTIAL ADVERSE EVENTS. THE INVESTIGATOR REPORTED THAT THE STROKE EVENT IS NOT RELATED TO THE INDEX PROCEDURE OR THE STUDY DEVICE, THE CAUSE OF THE STROKE AND DEATH ARE MOST LIKELY RELATED TO THE REPORTED PATIENT COMORBIDITIES AND HYPERTENSIVE CRISIS AND UNRELATED TO THE IMPLANTED STENT. THE INVESTIGATOR REPORTED THAT THE NSTEMI IS POSSIBLY RELATED TO INDEX PROCEDURE AND STUDY DEVICE. WHILE MYOCARDIAL INFARCTION (MI) IS DEEMED UNRELATED TO STROKE AND DEATH, THE CAUSE OF THE MI WAS NOT ABLE TO BE DETERMINED; IT CANNOT BE STATED WITH ABSOLUTE CERTAINTY THAT THERE IS NOT A RELATIONSHIP BETWEEN MI AND THE COBRA STENT IMPLANTED APPROXIMATELY 4 YEARS PRIOR AND, THOUGH UNLIKELY, IT CANNOT BE STATED WITH ABSOLUTE CERTAINTY THAT THE MI DID NOT CONTRIBUTE TO STROKE AND DEATH. 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.

    Additional Manufacturer Narrative · 0

    IF FOLLOW-UP, WHAT TYPE: ADDITIONAL INFORMATION: EVENT: REVISED. CODING REVISED. STENT REMAINS IMPLANTED IN PATIENT. AS EVENT OCCURRED APPROXIMATELY 4 YEARS AFTER INDEX PROCEDURE AND THERE WERE NO REPORTED DEVICE MALFUNCTIONS, THE DELIVERY SYSTEM IS PRESUMED DISCARDED AND WILL NOT BE REQUESTED. A REVIEW OF THE LOT HISTORY RECORD (LHR) INDICATED THAT THERE WERE NO NON-CONFORMANCES RELATED TO THE REPORTED ADVERSE EVENT. THE LOT CONFORMS TO ITS PREDETERMINED SPECIFICATIONS AND REQUIREMENTS. A REVIEW OF COBRA PZF INSTRUCTIONS FOR USE (IFU) WAS CONDUCTED. MYOCARDIAL INFARCTION, STROKE, AND DEATH ARE LABELED IN THE IFU AS KNOWN POTENTIAL ADVERSE EVENTS. THE INVESTIGATOR REPORTED THAT THE EVENT IS NOT RELATED TO THE INDEX PROCEDURE OR THE STUDY DEVICE, THE CAUSE OF THE STROKE AND DEATH ARE MOST LIKELY RELATED TO THE REPORTED PATIENT COMORBIDITIES / MEDICAL HISTORY AND UNRELATED TO THE IMPLANTED STENT. HOWEVER, MYOCARDIAL INFARCTION (MI) CAUSE WAS NOT ABLE TO BE DETERMINED; IT CANNOT BE STATED WITH ABSOLUTE CERTAINTY THAT THERE IS NOT A RELATIONSHIP BETWEEN MI AND THE COBRA STENT IMPLANTED APPROXIMATELY 4 YEARS PRIOR AND, THOUGH UNLIKELY, IT CANNOT BE STATED WITH ABSOLUTE CERTAINTY THAT THE MI DID NOT CONTRIBUTE TO STROKE AND DEATH. 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

    SUBSEQUENT TO THE PREVIOUSLY SUBMITTED FINAL MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED FROM THE SITE ON 11-MAR-2020 : THE PRINCIPLE INVESTIGATOR RE-ASSESSED THE REPORTED NON-ST-ELEVATED MYOCARDIAL INFARCTION (NSTEMI) AS POSSIBLY RELATED TO INDEX PROCEDURE AND STUDY DEVICE. THIS ADDITIONAL INFORMATION RESULTED IN THE FOLLOWING REVISED NARRATIVE AND REVISED DEVICE EVALUATION (H10): B5 REVISED NARRATIVE: A 76-YEAR-OLD MALE WITH MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD) WITH PRIOR PERCUTANEOUS CORONARY INTERVENTION (PCI) IN 2008, DIABETES MELLITUS, HYPERTENSION, THROMBOCYTOPENIA, GASTROESOPHAGEAL REFLUX DISEASE (GERD), PRIMARY SCLEROSING CHOLANGITIS, AND PRIOR SMOKER (1 PACK/DAY) PRESENTED WITH STABLE ANGINA. ANGIOGRAPHY SHOWED A 70% STENOSED TYPE B1 DE NOVO LESION IN THE DISTAL LEFT CIRCUMFLEX (DLCX) CORONARY ARTERY. PATIENT ENROLLED IN COBRA TRIAL ON (B)(6) 2014. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITH DUAL ANTI-PLATELET THERAPY (DAPT) PRESCRIBED. THE PATIENT UNDERWENT PCI, WITHOUT PRE-DILATATION OF THE LESION, VIA OF A 3.5X15MM COBRA PZF¿ STENT IN THE DLCX. NO POST-DILATATION WAS REQUIRED. THE PROCEDURE WAS CONCLUDED WITHOUT COMPLICATION. ON (B)(6) 2018: THE PATIENT PRESENTED TO EMERGENCY DEPARTMENT WITH ALTERED MENTAL STATUS WITH GENERALIZED WEAKNESS AND UNABLE TO MOVE FROM BED. HE DENIED ANY CHEST PAIN. COMPUTERIZED TOMOGRAPHY (CT) OF THE HEAD ON (B)(6) 2018 WAS WITHOUT EVIDENCE OF INTRACRANIAL HEMORRHAGE, MASS LESION, OR ACUTE TERRITORIAL INFARCT. ON (B)(6) 2018: PATIENT DEVELOPED NON-ST-ELEVATED MYOCARDIAL INFARCTION (NSTEMI), AND HYPERTENSIVE EMERGENCY; AFTER MEDICALLY TREATED, THE PATIENT CONTINUED TO WORSEN, SO REPEATED CT OF HEAD ON (B)(6) 2018 SHOWED A LARGE ACUTE INFARCTION LEFT CEREBELLUM WITH MASS EFFECT ON THE FOURTH VENTRICLE LEADING TO CHEYNE-STOCKS BREATHING, DENSE COMA AND INTUBATION. NEW MILD HYDROCEPHALUS. CARDIAC CATHETERIZATION WAS PLANNED BUT REPORTEDLY UNABLE TO BE PERFORMED DUE TO THE PATIENT CONDITION. ON (B)(6) 2018 THE PATIENT HAD NO REFLEX AND NO SPONTANEOUS BREATHS. ON (B)(6) 2018: PATIENT EXPERIENCED CARDIOPULMONARY ARREST, WITH ACLS PROTOCOL STARTED, AND LATER THE PATIENT PRONOUNCED DEAD, LIKELY BRAIN DEATH DUE TO THE ACUTE CEREBELLAR STROKE. PER THE PRINCIPLE INVESTIGATOR THIS NSTEMI IS POSSIBLY RELATED TO INDEX PROCEDURE AND STUDY DEVICE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    A 76-YEAR-OLD MALE WITH RELEVANT MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD) WITH PRIOR PERCUTANEOUS CORONARY INTERVENTION (PCI) IN 2008, DIABETES MELLITUS, HYPERTENSION, THROMBOCYTOPENIA, GASTROESOPHAGEAL REFLUX DISEASE (GERD), PRIMARY SCLEROSING CHOLANGITIS, AND PRIOR SMOKER (1 PACK/DAY) PRESENTED WITH STABLE ANGINA. ANGIOGRAPHY SHOWED A 70% STENOSED TYPE B1 DE NOVO LESION IN THE DISTAL LEFT CIRCUMFLEX (DLCX) CORONARY ARTERY. PATIENT ENROLLED IN COBRA TRIAL ON (B)(6) 2014. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITH DUAL ANTI-PLATELET THERAPY (DAPT) PRESCRIBED. THE PATIENT UNDERWENT PCI, WITHOUT PRE-DILATATION OF THE LESION, VIA OF A 3.5X15MM COBRA PZF¿ STENT IN THE DLCX. NO POST-DILATATION WAS REQUIRED. THE PROCEDURE WAS CONCLUDED WITHOUT COMPLICATION. ON (B)(6) 2018: THE PATIENT PRESENTED TO EMERGENCY DEPARTMENT WITH ALTERED MENTAL STATUS WITH GENERALIZED WEAKNESS AND UNABLE TO MOVE FROM BED. HE DENIED ANY CHEST PAIN. COMPUTERIZED TOMOGRAPHY (CT) OF THE HEAD ON (B)(6) 2018 WAS WITHOUT EVIDENCE OF INTRACRANIAL HEMORRHAGE, MASS LESION, OR ACUTE TERRITORIAL INFARCT. ON (B)(6) 2018: PATIENT WAS ADMITTED FOR NON-ST-ELEVATE MYOCARDIAL INFARCTION (NSTEMI), AND HYPERTENSIVE EMERGENCY, AFTER BEEN MEDICALLY TREATED, THE PATIENT CONTINUED TO WORSEN, SO REPEATED CT OF HEAD ON (B)(6) 2018 SHOWED A LARGE ACUTE INFARCTION LEFT CEREBELLUM WITH MASS EFFECT ON THE FOURTH VENTRICLE. NEW MILD HYDROCEPHALUS. CARDIAC CATHETERIZATION WAS PLANNED BUT REPORTEDLY UNABLE TO BE PERFORMED. ON (B)(6) 2018 THE PATIENT HAD NO REFLEX AND NO SPONTANEOUS BREATHS. ON (B)(6) 2018: PATIENT EXPERIENCED CARDIOPULMONARY ARREST, ACLS PROTOCOL STARTED AND LATER THE PATIENT PRONOUNCED DEAD, LIKELY BRAIN DEATH DUE TO THE ACUTE CEREBELLAR STROKE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED 09-APR-2019. THE DEVICE WAS RECEIVED WITH BENT STRUTS AT THE DISTAL END OF THE STENT. DURING DEVICE ANALYSIS ON 26-APR-2019, THE FOLLOWING WAS NOTED: BLOOD WAS NOTED ON THE DEVICE (INDICATING POSSIBLE USE IN PATIENT ANATOMY); THE PROXIMAL SHAFT WAS SEPARATED NEAR THE PROXIMAL HUB; THE GUIDE WIRE NOTCH WAS DAMAGED / STRETCHED; THE STENT WAS LOOSE ON THE BALLOON AND INADVERTENTLY DISLODGED FROM THE BALLOON WITHOUT FORCE, DURING ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD (LHR) INDICATED THAT THERE WERE NO NON-CONFORMANCE'S OBSERVED FOR THIS LOT AND THE LOT CONFORMS TO ITS PREDETERMINED SPECIFICATIONS AND REQUIREMENTS, INCLUDING FOR STENT RETENTION. A RISK ASSESSMENT REVIEW INDICATES THAT STENT DAMAGE AND DISLODGEMENT RE CAPTURED AS FORESEEABLE EVENTS. THE INVESTIGATION DETERMINED THAT A DEFINITIVE CONCLUSIVE CAUSE IS NOT ABLE TO BE ASSIGNED TO THE REPORTED COMPLAINT. AS THE DEVICE WAS RECEIVED WITH EXTENSIVE DAMAGE AND BLOOD ON IT, THE DEVICE WAS LIKELY INTRODUCED INTO PATIENT ANATOMY; HOWEVER, THOUGH REQUESTED, THIS INFORMATION COULD NOT BE CONFIRMED. THE REPORTED STENT DAMAGE AND SUBSEQUENT DAMAGED OBSERVED DURING ANALYSIS OF THE DEVICE (LOOSE STENT AND SEPARATED SHAFT), THUS, LIKELY OCCURRED DURING USE IN THE PATIENT. THOUGH UNABLE TO BE CONFIRMED, THE CAUSE OF THIS DAMAGE IS LIKELY ATTRIBUTED TO EITHER PHYSICAL MANIPULATION OF DEVICE (UNKNOWN IF INTENTIONAL OR UNINTENTIONAL) OR MAY BE ATTRIBUTED TO CHALLENGING VESSEL MORPHOLOGY. 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) MALE PATIENT PRESENTED ON (B)(6) 2018 FOR TREATMENT OF A LESION IN THE RIGHT CORONARY ARTERY (RCA) AND A LESION IN THE LEFT CIRCUMFLEX (LCX) VIA PERCUTANEOUS CORONARY INTERVENTION (PCI). THE RCA WAS TREATED SUCCESSFULLY VIA DEPLOYMENT OF A 3.0X15MM COBRA PZF¿ NANOCOATED STENT. AT AN UNSPECIFIED TIME-POINT DURING THE PROCEDURE, IT WAS NOTED THAT A 2.5X15MM COBRA PZF¿ NANOCOATED CORONARY STENT HAD DAMAGED STENT STRUTS AND WAS NOT DEPLOYED IN THE LCX, AS PLANNED. AFTER PRE-DILATING THE LCX LESION, ANOTHER 2.5X15MM COBRA PZF¿ NANOCOATED CORONARY STENT SYSTEM WAS ADVANCED AND SUCCESSFULLY DEPLOYED. THERE WERE NO ADVERSE PATIENT EFFECTS. THE DEVICE WAS RECEIVED WITH BENT STRUTS AT THE DISTAL END OF THE STENT. DURING DEVICE ANALYSIS ON 26-APR-2019, THE FOLLOWING WAS NOTED: BLOOD WAS NOTED ON THE DEVICE (INDICATING POSSIBLE USE IN PATIENT ANATOMY); THE PROXIMAL SHAFT WAS SEPARATED NEAR THE PROXIMAL HUB; THE GUIDE WIRE NOTCH WAS DAMAGED / STRETCHED; THE STENT WAS LOOSE ON THE BALLOON AND INADVERTENTLY DISLODGED FROM THE BALLOON WITHOUT FORCE, DURING ANALYSIS; THERE WAS NO EVIDENCE OF ATTEMPTED INFLATION. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435824 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. NA 1706294001 0087939700678

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR STENT: 3.0X15MM COBRA PZF.