BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBRA PZF

    MDR report key: 10861248 · Received November 18, 2020

    Report

    Report Number
    3009306400-2020-00028
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    October 21, 2020
    Report Date
    January 6, 2021
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    PMA / PMN Number
    P160014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B5 REVISED: H6 CODING REVISED AND HEALTH IMPACT CODE REMAINS 4614 (WE WERE UNABLE TO ENTER THIS CODE IN H6 SECTION). 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 REPORTED, LOT HISTORY REVIEW WAS UNABLE TO BE CONDUCTED. RESTENOSIS IS CAPTURED IN THE RISK ASSESSMENT AND THE INSTRUCTIONS FOR USE AS A KNOWN POTENTIAL HARM. IN THIS CASE, CAUSE OF RESTENOSIS WAS UNABLE TO BE DETERMINED. A RELATIONSHIP BETWEEN RESTENOSIS AND THIS 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 MALPOSITION 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. THE OTHER COBRA IN-STENT RESTENOSIS EVENT IS REPORTED UNDER SEPARATE MANUFACTURER REPORT NUMBER 3009306400-2020-00029.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A PHYSICIAN, DURING A SITE VISIT ON (B)(6) 2020 FROM A CELONOVA REPRESENTATIVE, THAT TWO IN-STENT RESTENOSIS EVENTS HAD OCCURRED AT THE SITE IN THE LAST WEEK WITH COBRA PZF¿ NANOCOATED STENT (EXACT EVENT DATES UNKNOWN AT THIS TIME). NO ADDITIONAL INFORMATION HAS BEEN REPORTED, TO DATE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED. THE OTHER COBRA IN-STENT RESTENOSIS EVENT WAS REPORTED UNDER SEPARATE MANUFACTURER REPORT NUMBER 3009306400-2020-00029.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS ESTIMATED. REPORTER IS NOT THE USER OF DEVICE. USER IS UNKNOWN AT THIS TIME. (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 REPORTED, LOT HISTORY REVIEW WAS UNABLE TO BE CONDUCTED. RESTENOSIS IS CAPTURED IN THE RISK ASSESSMENT AND THE INSTRUCTIONS FOR USE AS A KNOWN POTENTIAL HARM. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL SIGNIFICANT, RELEVANT INFORMATION. THE OTHER COBRA IN-STENT RESTENOSIS EVENT IS BEING REPORTED UNDER SEPARATE MANUFACTURER REPORT NUMBER 3009306400-2020-00029.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PHYSICIAN, DURING A SITE VISIT 28-OCT-2020 FROM A CELONOVA REPRESENTATIVE, THAT TWO IN-STENT RESTENOSIS EVENTS HAD OCCURRED WITH ANOTHER PHYSICIAN AT THAT SITE IN THE LAST WEEK WITH COBRA PZF¿ NANOCOATED STENT (EXACT EVENT DATES UNKNOWN AT THIS TIME). NO ADDITIONAL INFORMATION HAS BEEN REPORTED, TO DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE OTHER COBRA IN-STENT RESTENOSIS EVENT IS BEING REPORTED UNDER A SEPARATE MANUFACTURER REPORT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323101 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization