BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA PZF

    MDR report key: 10255499 · Received July 9, 2020

    Report

    Report Number
    3009306400-2020-00021
    Event Type
    Malfunction
    Date Received
    July 9, 2020
    Date of Event
    April 21, 2020
    Report Date
    July 7, 2020
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397201031
    PMA / PMN Number
    P160014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT IS 101.9 KG. THE DEVICE RECEIVED ON 10JUN2020. DEVICE ANALYSIS WAS PERFORMED 25-JUN-2020. COMPLAINTS SPECIALIST PERFORMED APPLICABLE VISUAL AND DIMENSIONAL ANALYSIS ON THE USED RETURNED DELIVERY SYSTEM. COMPLAINTS SPECIALIST RECEIVED THE DELIVERY SYSTEM IN THE FOLLOWING CONDITION: BALLOON TIGHTLY FOLDED, INDICATING THAT NO INFLATION OR DEPLOYMENT ATTEMPTS MADE; STENT CRIMPED, STENT MOVEMENT TOWARDS THE DISTAL END (OVER DISTAL BALLOON MARKER) AND EVIDENCE OF CRIMPED MARKS OBSERVED IN THE EXPOSED PROXIMAL END OF BALLOON. STENT DAMAGE (LIFTED STRUTS) AT THE PROXIMAL END NOTED. APPLICABLE DIMENSIONAL ANALYSIS ON THE RETURNED DEVICE MET PRODUCT SPECIFICATIONS. COMPLAINTS SPECIALIST WAS UNABLE TO REPLICATE THE REPORTED EVENT IN A TESTING ENVIRONMENT DUE TO PROCEDURAL, ANATOMICAL CIRCUMSTANCES, AND / OR OTHER UNCONTROLLED FACTORS POSSIBLY RELATED TO THE PROCEDURE ITSELF. 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 VISUAL INSPECTION OF THE STENT, CROSSING PROFILE, AND STENT RETENTION. RISK ASSESSMENT REVIEW INDICATES THAT INABILITY TO CROSS, STENT DAMAGE, AND LOOSE / SHIFTED STENT ARE CAPTURED AS KNOWN POTENTIAL HAZARDS. THE INVESTIGATION DETERMINED THAT A DEFINITIVE CONCLUSIVE CAUSE IS NOT ABLE TO BE ASSIGNED TO THE REPORTED COMPLAINT. THOUGH UNABLE TO BE CONFIRMED, IN THIS CASE, INABILITY TO CROSS, STENT DAMAGE, AND STENT MOVEMENT (NOTED DURING DEVICE ANALYSIS) IS MOST LIKELY DUE TO INTERACTION WITH THE PREVIOUSLY IMPLANTED NON-CELONOVA RESTENOSED STENT. 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

    ON (B)(6) 2020, A (B)(6) YEAR OLD MALE PATIENT PRESENTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR TREATMENT OF A MILDLY CALCIFIED LESION IN THE MILDLY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. A 3.5X12MM COBRA PZF¿ NANOCOATED CORONARY STENT SYSTEM WAS ADVANCED VIA RIGHT RADIAL ACCESS, BUT WAS UNABLE TO CROSS THE TARGET LESION DUE TO INTERACTION WITH A PREVIOUSLY IMPLANTED RESTENOSED NON-CELONOVA STENT; STENT DAMAGE WAS NOTED UPON WITHDRAWAL IF THE DELIVERY SYSTEM. THE TARGET LESION WAS TREATED VIA DEPLOYMENT OF A DRUG-ELUTING STENT. THERE WERE NO ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE WAS RECEIVED WITH ITS STENT SHIFTED DISTALLY ON THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719989 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 1710234004 00879397201031

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR