BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA PZF

    MDR report key: 9715132 · Received February 15, 2020

    Report

    Report Number
    3009306400-2020-00002
    Event Type
    Malfunction
    Date Received
    February 15, 2020
    Date of Event
    January 17, 2020
    Report Date
    February 15, 2020
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397007455
    PMA / PMN Number
    P160014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED, BUT STENT REMAINS IMPLANTED IN PATIENT AND DELIVERY SYSTEM IS PRESUMED DISCARDED. A REVIEW OF THE LOT HISTORY RECORD (LHR) WAS PERFORMED. THERE WERE NO NON-CONFORMANCES. THE LOT CONFORMS TO ITS PREDETERMINED SPECIFICATIONS AND REQUIREMENTS, INCLUDING FOR STENT RETENTION. LOOSE STENT IS CAPTURED IN THE RISK ASSESSMENT AS A KNOWN POTENTIAL HAZARD. THE INVESTIGATION DETERMINED THAT A DEFINITIVE CONCLUSIVE CAUSE IS NOT ABLE TO BE ASSIGNED TO THE REPORTED COMPLAINT. THE CAUSE OF LOOSE STENT MAY POSSIBLY BE ATTRIBUTED TO INADEQUATE LESION PREPARATION (NO PREDILATATION), CHALLENGING VESSEL MORPHOLOGY, INADVERTENT INFLATION OF DEVICE DURING USE, AND / OR INTERACTION WITH ACCESSORY DEVICE(S) (SUCH AS GUIDING CATHETER, SUPPORT CATHETER, AND / OR HEMOSTATIC VALVE). 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. THE OTHER COBRA PZF STENT IS BEING REPORTED UNDER MANUFACTURER REPORT NUMBER 3009306400-2020-00003.

    Description of Event or Problem · 1

    AN (B)(6)-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY OF CORONARY ARTERY DISEASE, PRIOR STENTING, DYSLIPIDEMIA, MYOCARDIAL INFARCTION, AND FORMER SMOKING PRESENTED FOR PLANNED PERCUTANEOUS CORONARY INTERVENTION (PCI) ON (B)(6) 2020. ANGIOGRAPHY SHOWED RECURRENCE OF STENOSIS OF A PREVIOUSLY IMPLANTED UNKNOWN STENT IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA), AS WELL AS MODERATE STENOSIS (30 TO 50%) THROUGHOUT BOTH LEFT AND RIGHT CORONARY VESSELS. AFTER POSITIONING 6F/AR1 GUIDE CATHETER AND 0.014" BMW GUIDE WIRE IN TARGET VESSEL, A 4.0X12MM COBRA PZF¿ NANOCOATED STENT WAS DEPLOYED IN THE RCA OSTIUM VIA DIRECT STENTING. THE DISTAL AND MID RCA WAS THEN DILATED USING THE 4X12 MM STENT BALLOON. THE PROXIMAL RCA WAS THEN PRE-DILATED USING A COBRA DELIVERY SYSTEM BALLOON, FOLLOWED BY DEPLOYMENT OF A 4.0X15MM COBRA PZF¿ STENT. THE PHYSICIAN REPORTED THAT DURING THE PROCEDURE, BOTH COBRA PZF¿ NANOCOATED STENTS WERE NOTED TO BE LOOSE (4.0X12MM AND 4.0X15MM) WHILE RETRIEVING WITHIN THE GUIDING CATHETER TO THE RCA. BOTH COBRA STENT DELIVERY SYSTEMS WERE ABLE TO CROSS AND THE STENTS WERE ULTIMATELY IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178285 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 1706084002 00879397007455

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR