BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA PZF

    MDR report key: 7289082 · Received February 22, 2018

    Report

    Report Number
    3009306400-2018-00008
    Event Type
    Malfunction
    Date Received
    February 22, 2018
    Date of Event
    January 15, 2018
    Report Date
    May 4, 2018
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397000920
    PMA / PMN Number
    P160014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ANY ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    VISUAL AND DIMENSIONAL TESTING WAS PERFORMED ON THE RETURNED DEVICE. WHILE THE STENT WAS RECEIVED IN A NON-DISLODGED STATE, THE RETURNED DEVICE APPEARS TO HAVE HAD ITS STENT DISLODGED WITH THE STENT LIKELY MANUALLY PUSHED BACK ONTO THE BALLOON, AS THE SENT WAS LOOSE AND NOT FIRMLY CRIMPED BETWEEN THE BALLOON MARKERS (THE USER ALSO INDICATED THE STENT WAS DISLODGED AND WAS RETRIEVED FROM THE TOUHY VALVE). DAMAGED STENT STRUTS AND KINKED DISTAL SHAFT CONFIRM THE REPORTED CROSSING DIFFICULTY AND RETRIEVAL FROM TOUHY VALVE. CRIMP/PILLOW MARKS WERE VISIBLE ON THE BALLOON, INDICATING THAT THE STENT WAS FIRMLY CRIMPED ON THE BALLOON BETWEEN THE MARKERS PRIOR TO DISLODGEMENT. BALLOON FOLD CREASES WERE VISUALIZED, INDICATING THAT THE BALLOON WAS NOT LIKELY COMPLETELY EXPANDED, BUT THE BALLOON IS NOT TIGHTLY FOLDED AND THE STENT APPEARS TO HAVE BEEN SLIGHTLY EXPANDED, INDICATING THAT A SLIGHT INFLATION ATTEMPT BY THE USER MAY HAVE OCCURRED, WHICH MAY HAVE AFFECTED STENT RETENTION. A REVIEW OF THE LOT HISTORY RECORD (LHR) CONFIRMED THAT THERE WERE NO NON-CONFORMANCES; THE DEVICES FROM THIS LOT CONFORM TO THEIR PREDETERMINED SPECIFICATIONS, INCLUDING FOR STENT RETENTION. WHILE A DEFINITIVE CONCLUSIVE CAUSE IS NOT ABLE TO BE ASSIGNED TO THE REPORTED COMPLAINT, EVIDENCE SUGGESTS THAT VESSEL CALCIFICATION, INADVERTENT SLIGHT BALLOON/STENT EXPANSION, AND STENT SYSTEM INTERACTION WITH THE TUOHY HEMOSTATIC VALVE MAY CONTRIBUTED TO THE REPORTED ADVANCEMENT DIFFICULTY AND STENT DISLODGEMENT. 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 PATIENT PRESENTED WITH LESIONS IN THE PROXIMAL AND DISTAL RIGHT CORONARY ARTERY (RCA). AN ATTEMPT WAS MADE TO CROSS THE PROXIMAL LESION WITH A 4.0X18MM COBRA PZF STENT DELIVERY SYSTEM, BUT IT WAS UNABLE TO CROSS DUE TO VESSEL CALCIFICATION. DURING WITHDRAWAL OF THE STENT SYSTEM THROUGH THE TOUHY VALVE, THE STENT CAME OFF OF THE BALLOON. THE DISLODGED STENT WAS RETRIEVED FROM INSIDE OF THE TOUHY. THE PATIENT WAS SUCCESSFULLY TREATED WITH A NEW 4.0X18MM COBRA. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 1

    (B)(6) MALE PATIENT PRESENTED WITH VERY CALCIFIED LESIONS IN THE PROXIMAL AND DISTAL RIGHT CORONARY ARTERY (RCA). AN ATTEMPT WAS MADE TO CROSS THE PROXIMAL LESION WITH A 4.0X18MM COBRA PZF STENT DELIVERY SYSTEM, BUT IT WAS UNABLE TO CROSS DUE TO LESION CALCIFICATION. DURING WITHDRAWAL OF THE STENT SYSTEM THROUGH THE TOUHY VALVE, THE STENT CAME OFF OF THE BALLOON. THE DISLODGED STENT WAS RETRIEVED FROM INSIDE OF THE TOUHY. THE PATIENT WAS SUCCESSFULLY TREATED WITH A NEW 4.0X18MM COBRA. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132783 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 1708094001 00879397000920

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR