BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBRA PZF

    MDR report key: 12813479 · Received November 15, 2021

    Report

    Report Number
    3009306400-2021-00006
    Event Type
    Injury
    Date Received
    November 15, 2021
    Report Date
    December 30, 2021
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    PMA / PMN Number
    P160014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 CODING REVISED. H6: HEALTH EFFECT - IMPACT CODE IS 4614 (ESUBMITTER WOULD NOT ALLOW ENTRY OF THIS CODE INTO H6). STENT REMAINS IMPLANTED IN PATIENT. AS THERE WAS NO REPORTED DEVICE MALFUNCTION, THE DELIVERY SYSTEM IS PRESUMED DISCARDED AND WAS NOT REQUESTED. AS THE LOT NUMBER WAS NOT PROVIDED BY THE SITE, A REVIEW OF THE LOT HISTORY RECORD (LHR) WAS UNABLE TO BE CONDUCTED. RESTENOSIS IS CAPTURED IN THE RISK ASSESSMENT AND INSTRUCTIONS FOR USE AS A KNOWN POTENTIAL HARM. IN THIS CASE, THE INVESTIGATION DETERMINED THAT CAUSES OF RESTENOSIS ARE UNABLE TO BE DETERMINED. THUS, A RELATIONSHIP BETWEEN RESTENOSIS AND STUDY DEVICE CANNOT BE COMPLETELY EXCLUDED. INTRACORONARY STENT RESTENOSIS IS MULTIFACTORIAL (INCLUDING, BUT NOT LIMITED TO, PATIENT LESION TYPE, DISEASE PROGRESSION, COMORBIDITIES, AND VESSEL TRAUMA DURING THE INDEX PROCEDURE). RESTENOSIS CAN ALSO RESULT FROM MALAPPOSITION OF THE STENT/SUB-OPTIMAL STENT EXPANSION (STENT UNABLE TO MAINTAIN INTENDED PATENCY, LOSS OF STRENGTH DUE TO FRACTURE, POSITION OF STENT COMPROMISED, USE ERROR OF INCORRECT DEPLOYMENT, SMALLER DEPLOYED DIAMETER). THE IDENTIFICATION OF RESTENOSIS AT THE SITE OF THE TREATED LESION DOES NOT IMPLY A TECHNICAL PROBLEM WITH THE STUDY DEVICE OR STUDY 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.

    Additional Manufacturer Narrative · 0

    (B)(4). STENT REMAINS IMPLANTED IN PATIENT. AS THERE WAS NO REPORTED DEVICE MALFUNCTION, THE DELIVERY SYSTEM IS PRESUMED DISCARDED AND WAS NOT REQUESTED. AS THE LOT NUMBER WAS NOT PROVIDED BY THE SITE, A REVIEW OF THE LOT HISTORY RECORD (LHR) WAS UNABLE TO BE CONDUCTED. RESTENOSIS IS CAPTURED IN THE RISK ASSESSMENT AND INSTRUCTIONS FOR USE AS A KNOWN POTENTIAL HARM. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WITH ADDITIONAL, RELEVANT INFORMATION RECEIVED WILL BE PROVIDED.

    Description of Event or Problem · 0

    A PATIENT PRESENTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) ON AN UNKNOWN DATE. AN UNSPECIFIED SIZE OF COBRA PZF¿ NANOCOATED CORONARY STENT WAS IMPLANTED IN AN UNSPECIFIED VESSEL. AT A LATER UNKNOWN DATE, THE PHYSICIAN ENCOUNTERED A RESTENOSIS EVENT WITH THE IMPLANTED COBRA STENT. THE PHYSICIAN REPORTED THAT THE RESTENOSIS DID NOT RESULT IN PATIENT HARM; THE PATIENT WAS TREATED FOR THE RESTENOSIS; AND THE PATIENT WAS DISCHARGED WITHOUT FURTHER ISSUES. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    A PATIENT PRESENTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) ON AN UNKNOWN DATE. AN UNSPECIFIED SIZE OF COBRA PZF¿ NANOCOATED CORONARY STENT WAS IMPLANTED IN AN UNSPECIFIED VESSEL. AT A LATER UNKNOWN DATE, THE PHYSICIAN ENCOUNTERED A RESTENOSIS EVENT WITH THE IMPLANTED COBRA STENT. THE PHYSICIAN REPORTED THAT THE RESTENOSIS DID NOT RESULT IN PATIENT HARM; THE PATIENT WAS TREATED FOR THE RESTENOSIS; AND THE PATIENT WAS DISCHARGED WITHOUT FURTHER ISSUES. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT YET BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1710201 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention