BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBRA PZF

    MDR report key: 7015118 · Received November 9, 2017

    Report

    Report Number
    3009306400-2017-00014
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    October 6, 2017
    Report Date
    December 6, 2017
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    PMA / PMN Number
    P160014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL AND DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE STENT WAS CONFIRMED TO BE DISLODGED. FAILURE TO CROSS WAS UNABLE TO BE PERFORMED IN A TESTING ENVIRONMENT AND DUE TO THE CONDITION OF THE RETURNED DEVICE. A REVIEW OF THE LOT HISTORY RECORD (LHR) CONFIRMED THAT THERE WERE NO NON-CONFORMANCES THAT OCCURRED RELATED TO THIS, INDICATING THAT THE DEVICES FROM THIS LOT CONFORM TO THEIR PREDETERMINED SPECIFICATIONS. THE INVESTIGATION DETERMINED THAT WHILE A DEFINITIVE CONCLUSIVE CAUSE IS NOT ABLE TO BE ASSIGNED TO THE REPORTED COMPLAINT, THE REPORTED ADVANCEMENT DIFFICULTY AND 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. IT SHOULD BE NOTED THAT THE COBRA PZF STENT INSTRUCTIONS FOR USE INSTRUCTS THE USER TO SELECT A GREATER THAN OR EQUAL TO 5F CATHETER WITH A MINIMUM INNER DIAMETER (ID) OF 0.056". THE VASCULAR SOLUTIONS 5.5FR GUIDELINER HAS AN ID OF 0.051" PER ITS PRODUCT SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(6). THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS BUT HAS NOT YET BEEN RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, ON (B)(6) 2017, THE PROCEDURE WAS TO TREAT A SIGMA SHAPED (TORTUOUS) RIGHT CORONARY ARTERY (RCA) WITH TWO AREAS OF DISEASE, INCLUDING A 90 TO 95% STENOSED LESION, FOR A (B)(6) MALE PATIENT. A 3.5 X 15 MM COBRA PZF NANOCOATED STENT DELIVERY SYSTEM (SDS) WAS ADVANCED VIA RIGHT GROIN ACCESS OVER A NON-CELONOVA 014 GUIDE WIRE AND INTO A 6FR NON-CELONOVA GUIDING CATHETER. A 5.5 FR GUIDELINER WAS USED TO AID COBRA ADVANCEMENT. ATTEMPTS WERE MADE TO CROSS THE 1ST LESION (LOCATED IN THE 1ST TWO CENTIMETERS OF THE PROXIMAL RCA), WHICH HAD AN ECCENTRIC AND DENSELY CALCIFIED, CAULIFLOWER-SHAPED NODULE AND WAS LOCATED IN THE GREATER CURVE OF THE BEND IN THE PROXIMAL RCA; HOWEVER, THE SDS WAS UNABLE TO CROSS DUE TO SIGNIFICANT OBSTRUCTION OF THE GUIDELINER IN THE PROXIMAL RCA AND DUE TO THE ANATOMY, AND THE SDS WAS WITHDRAWN. DURING WITHDRAWAL THROUGH THE GUIDING CATHETER TIP, THE STENT DISLODGED AND EMBOLIZED TO THE PROXIMAL RCA. THE STENT WAS SUCCESSFULLY SNARED WITHOUT ADVERSE PATIENT SEQUELAE. DILATION WAS PERFORMED USING A NON-CELONOVA 2.5 X 12 MM BALLOON, FOLLOWED BY CROSSING AND DEPLOYMENT OF A 3.5 X 15 NON-CELONOVA STENT. PATIENT OUTCOME IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792192 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 1705054003

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention