BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBRA PZF

    MDR report key: 8812732 · Received July 22, 2019

    Report

    Report Number
    3009306400-2019-00033
    Event Type
    Death
    Date Received
    July 22, 2019
    Date of Event
    April 10, 2015
    Report Date
    July 22, 2019
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397000395
    PMA / PMN Number
    P160014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STENT REMAINS IMPLANTED IN PATIENT. AS EVENT OCCURRED MORE THAN 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. RESTENOSIS, MYOCARDIAL INFARCTION, AND DEATH ARE LISTED IN THE IFU AS KNOWN POTENTIAL ADVERSE EVENTS. THE INVESTIGATOR REPORTED THAT THE EVENT IS NOT RELATED TO THE INDEX PROCEDURE, BUT POSSIBLY RELATED TO THE STUDY DEVICE, AND THAT THROMBOSIS COULD NOT BE EXCLUDED AS A POSSIBLE CAUSE. THE CAUSES OF THE ADVERSE EVENTS ARE LIKELY MULTIFACTORIAL (INCLUDING, BUT NOT LIMITED TO, PATIENT LESION TYPE, DISEASE PROGRESSION, COMORBIDITIES, AND MEDICAL HISTORY. HOWEVER, A RELATIONSHIP BETWEEN THE EVENTS AND STUDY DEVICE CANNOT 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 MALE WITH RELEVANT MEDICAL HISTORY OF CORONARY ARTERY DISEASE (CAD) WITH PRIOR NON-QW MYOCARDIAL INFARCTION (MI) ON (B)(6) 2011, PERCUTANEOUS CORONARY INTERVENTION (PCI) IN (B)(6) 2011, PERIPHERAL VASCULAR DISEASE OF LEFT EXTERNAL ILIAC ARTERY ((B)(6) 2010), HYPERTENSION AND HYPERLIPEMIA SINCE 1995, ATRIAL FIBRILLATION ((B)(6) 2011), AND SMOKER (1.5 PACKS/DAY) PRESENTED WITH STABLE ANGINA. ANGIOGRAPHY SHOWED AN 80% STENOSED TYPE B1 DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) CORONARY ARTERY. PATIENT ENROLLED IN COBRA TRIAL ON (B)(6) 2014. THE PATIENT UNDERWENT PCI, WITH PRE-DILATATION OF THE LESION, FOLLOWED BY DEPLOYMENT OF A 2.75X24MM COBRA PZF¿ STENT IN THE MLAD THEN POST-DILATATION USING THE STENT BALLOON. THE PROCEDURE WAS CONCLUDED AND PATIENT WAS DISCHARGED THE FOLLOWING DAY. 30-DAY FOLLOW-UP ((B)(6) 2014): NO ADVERSE EVENTS; NO CHANGES IN MEDICATION. 180-DAYS FOLLOW-UP ((B)(6) 2015): NO ADVERSE EVENTS. ON (B)(6) 2015, PATIENT HAD NO SYMPTOMS, BUT ROUTINE FOLLOW-UP ANGIOGRAM SHOWED IN-STENT RESTENOSIS IN MLAD DISEASE PROGRESSION APPROXIMATELY 10MM DISTAL TO STUDY STENT. A LONG DRUG-ELUTING SENT WAS DEPLOYED, COVERING BOTH TARGET AREAS. ON (B)(6) 2018, PATIENT WAS ADMITTED TO ER FOR NON-CARDIAC CHEST PAIN AND SEVERE HYPERTENSION (BP = 236/138); PRIOR ANGIOGRAPHY PERFORMED (B)(6) 2018 SHOWED PATENT LAD STENT AND DISEASE PROGRESSION. CT OF CHEST AND ABDOMEN IDENTIFIED ABDOMINAL AORTIC ANEURYSM. EVENT WAS RESOLVED BY (B)(6) 2018 WITH MEDICATION. THIS EVENT WAS DEEMED DUE TO UNCONTROLLED HYPERTENSION PER INVESTIGATOR. ON (B)(6) 2019 PATIENT WAS DISCOVERED AT RESIDENCE TO HAVE EXPIRED. THE PATIENT WAS REPORTED BY SPOUSE TO HAVE BEEN ASYMPTOMATIC PRIOR TO EXPIRING AND FELT THAT EXPIRATION MAY HAVE BEEN RELATED TO COPD OR HEART. PATIENT HAD BEEN REPORTEDLY NON-COMPLIANT WITH CARDIOLOGY FOLLOW-UP VISITS. DEATH CERTIFICATE SIGNED BY PRINCIPAL INVESTIGATOR INDICATES CAUSE OF DEATH AS CARDIOPULMONARY ARREST, ACUTE MYOCARDIAL INFARCTION, AND CORONARY ARTERY DISEASE PROGRESSION. PER THE INVESTIGATOR, THE EVENT IS NOT RELATED TO STUDY PROCEDURE, BUT POSSIBLY RELATED TO STUDY DEVICE, AND THE POSSIBILITY OF STENT THROMBOSIS CANNOT BE EXCLUDED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607249 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 1404024003 00879397000395

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| H| R