BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBRA PZF

    MDR report key: 8068963 · Received November 14, 2018

    Report

    Report Number
    3009306400-2018-00075
    Event Type
    Injury
    Date Received
    November 14, 2018
    Date of Event
    October 15, 2018
    Report Date
    December 11, 2018
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    PMA / PMN Number
    160014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER DETAILS WERE PROVIDED REGARDING STENT RETRIEVAL; THE STENT POSSIBLY REMAINS IN PATIENT ANATOMY. THE DELIVERY SYSTEM WAS REQUESTED, BUT WAS DISCARDED BY THE SITE. 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. THE INVESTIGATION DETERMINED THAT WHILE A DEFINITIVE CONCLUSIVE CAUSE IS NOT ABLE TO BE ASSIGNED TO THE REPORTED COMPLAINT, THE REPORTED DIFFICULTIES MAY BE ATTRIBUTED TO LESION CALCIFICATION, VESSEL MORPHOLOGY, AND/OR OTHER PROCEDURAL CIRCUMSTANCES. 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.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT WAS NOT PROVIDED, BUT DESCRIBED AS SLENDER. NO FURTHER DETAILS WERE PROVIDED REGARDING STENT RETRIEVAL; THE STENT POSSIBLY REMAINS IN PATIENT ANATOMY. THE DELIVERY SYSTEM WAS REQUESTED, BUT WAS DISCARDED BY THE SITE. AS THE LOT NUMBER WAS NOT PROVIDED, A LOT HISTORY REVIEW WAS UNABLE TO BE PERFORMED. THE INVESTIGATION DETERMINED THAT WHILE A DEFINITIVE CONCLUSIVE CAUSE IS NOT ABLE TO BE ASSIGNED TO THE REPORTED COMPLAINT, THE REPORTED DIFFICULTIES MAY BE ATTRIBUTED TO LESION CALCIFICATION, VESSEL MORPHOLOGY, AND / OR OTHER PROCEDURAL CIRCUMSTANCES. 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

    AN (B)(6) FEMALE PATIENT PRESENTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN THE OSTIAL RIGHT CORONARY ARTERY (RCA) ON (B)(6) 2018. THE LESION WAS PRE-DILATED. WHEN ADVANCING A 4.0X12MM COBRA PZF NANOCOATED CORONARY STENT SYSTEM TOWARD THE LESION, THE STENT DISLODGED. NO FURTHER DETAILS WERE PROVIDED REGARDING STENT RETRIEVAL; THE STENT POSSIBLY REMAINS IN PATIENT ANATOMY. THE TARGET LESION WAS TREATED WITH A 4.0X12MM DRUG-ELUTING STENT. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. NO COMPLICATION WAS REPORTED AFTER THE PROCEDURE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909359 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 1711134003

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other GUIDE CATHETER: 6 FR JL4 LAUNCHER| GUIDE CATHETER: JR4.0| GUIDE WIRE: BALANCE| GUIDE WIRE: BALANCE 180CM| SHEATH: 6F TERUMO| GUIDE CATHETER: 6 FR JL4 LAUNCHER| GUIDE WIRE: BALANCE