BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBRA PZF

    MDR report key: 6942543 · Received October 11, 2017

    Report

    Report Number
    3009306400-2017-00011
    Event Type
    Injury
    Date Received
    October 11, 2017
    Date of Event
    September 8, 2017
    Report Date
    October 11, 2017
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    PMA / PMN Number
    P160014
    Removal / Correction Number
    NONE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS, THE REPORTED ADVANCEMENT DIFFICULTY, RETRACTION DIFFICULTY, AND STENT DISLODGEMENT WERE UNABLE TO BE CONFIRMED VIA TESTING. HOWEVER, A REVIEW OF THE PROVIDED CINE IMAGES SUGGESTS THAT RESISTANCE OCCURRED AND CONFIRMS THE REPORT OF THE SHIFTING OF THE STENT AT THE PROXIMAL VESSEL NARROWING, JUST AFTER EXITING THE GUIDE CATHETER. A REVIEW OF THE LOT HISTORY RECORD REVEALED THAT THERE WERE NO NON-CONFORMANCES RELATED TO THE REPORTED DIFFICULTIES FOR THIS LOT AND A RISK ASSESSMENT REVIEW CONFIRMED THAT THE REPORTED DIFFICULTIES ARE CAPTURED AS FORESEEABLE EVENTS. THE INVESTIGATION DETERMINED THAT WHILE A DEFINITIVE CONCLUSIVE CAUSE IS NOT ABLE TO BE ASSIGNED TO THE REPORTED COMPLAINT, THE REPORTED ADVANCEMENT AND RETRACTION DIFFICULTIES AND REPORTED STENT DISLODGEMENT APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE 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

    IT WAS REPORTED THAT AFTER PRE-DILATING THE DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY (RCA) WITH AN UNSPECIFIED 3.0X15MM BALLOON, A 4.0 X 15MM COBRA PZF NANOCOATED STENT DELIVERY SYSTEM (SDS) WAS ADVANCED OVER A TERUMO RUNTHROUGH GUIDE WIRE AND INTO A MEDTRONIC JR4 GUIDING CATHETER VIA RIGHT FEMORAL ARTERY ACCESS TOWARD THE LESION WHEN RESISTANCE WAS FELT AGAINST THE PROXIMAL RCA DUE TO VESSEL TORTUOSITY AND CALCIFIED LESION WITH MODERATE STENOSIS (30-40%). WHEN PULLING THE SDS BACK SLIGHTLY, RESISTANCE WAS FELT AGAINST THE VESSEL AGAIN AND, THOUGH NO EXCESSIVE FORCE WAS APPLIED, THE STENT SHIFTED DISTALLY ON THE BALLOON. THE SDS BALLOON WAS PUSHED FORWARD TO CAPTURE THE SHIFTED STENT (FOR DISLODGEMENT PREVENTION) AND THE STENT WAS DEPLOYED IN THE PROXIMAL LESION OF THE PROXIMAL RCA, OUTSIDE OF THE TARGET LESION. A GUIDELINER GUIDING CATHETER WAS THEN ADVANCED THROUGH THE STENTED AREA AND A 4.0MM MEDTRONIC STENT WAS DEPLOYED, TREATING THE MID RCA. THERE WERE NO ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720846 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 1703294002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention