BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBRA PZF

    MDR report key: 7793956 · Received August 17, 2018

    Report

    Report Number
    3009306400-2018-00044
    Event Type
    Injury
    Date Received
    August 17, 2018
    Date of Event
    December 7, 2016
    Report Date
    August 17, 2018
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397000463
    PMA / PMN Number
    160014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE STENT REMAINS IMPLANTED IN THE PATIENT AND THE ADVERSE EVENT OCCURRED APPROXIMATELY THREE MONTHS POST INDEX PROCEDURE, THE DEVICE WAS NOT REQUESTED FOR RETURN. THE DEVICE LOT HISTORY RECORD REVIEW INDICATES THAT THERE ARE NO NON-CONFORMANCES ISSUED TO THIS LOT AND THAT THIS DEVICE MET ITS PRE-DETERMINED SPECIFICATIONS. RESTENOSIS IS LISTED IN THE COBRA PZF INSTRUCTIONS FOR USE AS A LABELED POTENTIAL ADVERSE EVENT. THE INVESTIGATOR CONSIDERED THE EVENT POSSIBLY RELATED TO THE STUDY DEVICE. RESTENOSIS IS AN ANTICIPATED ISSUE AFTER PERCUTANEOUS CORONARY INTERVENTION AND THE CAUSE OF IT IS DIFFICULT TO DETERMINE WHETHER IT IS SPECIFIC TO REDUCED DEVICE EFFICACY OR DISEASE PROGRESSION. RESTENOSIS IS UNDOUBTEDLY MULTIFACTORIAL. THE IDENTIFICATION OF RESTENOSIS AT THE SITE OF THE TREATED LESION DOES NOT IMPLY A TECHNICAL PROBLEM WITH THE STUDY DEVICE OR STUDY PROCEDURE. THE REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE MET ITS PRE-DETERMINED MANUFACTURING SPECIFICATIONS. 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. AWARE DATE NOTE: AWARE DATE NOTE: CELONOVA BIOSCIENCES WAS INITIALLY MADE AWARE OF THIS EVENT ON 06-JUL-2017; AS THIS EVENT HAD OCCURRED PRIOR TO U.S. PRODUCT APPROVAL, IT WAS NOT REPORTED AT THAT TIME. PER CELONOVA BIOSCIENCES MANAGEMENT REVIEW OF COMPLAINTS, IT WAS DETERMINED BY MANAGEMENT (02-AUG-2018) THAT THE EVENT SHOULD BE CONSERVATIVELY REPORTED.

    Description of Event or Problem · 1

    INDEX PROCEDURE: ON (B)(6) 2016: 3.0 X 30 MM COBRA (PART 170-02-30030, LOT 1409244005) IMPLANTED IN MID RCA. PATIENT WAS DISCHARGED (B)(6) 2016. ADVERSE EVENTS: ON (B)(6) 2016: PATIENT PRESENTED WITH CHEST DISCOMFORT AND DYSPNEA. RE-HOSPITALIZED WITH RESOLUTE STENT PLACED WHERE STUDY STENT (COBRA) WAS PLACED IN THE RCA; PRE-TREATMENT STENOSIS = 95%, WITH 50% STENOSIS POST RESOLUTE DEPLOYMENT; RESOLVED (B)(6) 2016. PATIENT DISCHARGED IN STABLE CONDITION (B)(6) 2016. THE INVESTIGATOR INDICATED THAT THE EVENT IS NOT RELATED TO STUDY PROCEDURE, BUT POSSIBLY RELATED TO STUDY DEVICE. ON (B)(6) 2017: PATIENT RE-HOSPITALIZED FOR ACUTE CORONARY SYNDROME (CHEST PAIN). THIS WAS RESOLVED AND NOT CONSIDERED BY THE INVESTIGATOR TO BE RELATED TO PROCEDURE OR STUDY DEVICE. ON (B)(6) 2017: ADJUDICATION BY SPONSOR INDICATES THAT RESTENOSIS ETIOLOGY IS MULTIFACTORIAL AND RESTENOSIS OF LESION DOES NOT IMPLY A TECHNICAL PROBLEM WITH STUDY DEVICE OR PROCEDURE. ON (B)(6) 2017: PATIENT REHOSPITALIZED FOR STABLE ANGINA. INVESTIGATOR INDICATED THAT THE EVENT IS NOT RELATED TO PROCEDURE OR STUDY DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634716 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 1409244005 00879397000463

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R