BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBRA PZF

    MDR report key: 7962998 · Received October 12, 2018

    Report

    Report Number
    3009306400-2018-00033
    Event Type
    Injury
    Date Received
    October 12, 2018
    Date of Event
    July 17, 2018
    Report Date
    August 13, 2018
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397007479
    PMA / PMN Number
    160014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2: ONLY YEAR OF BIRTH GIVEN AS 1940. AS THE STENT REMAINS IMPLANTED IN THE PATIENT AND THE EVENT OCCURRED APPROXIMATELY 5 MONTHS AFTER THE INDEX PROCEDURE, THE DEVICE WAS NOT REQUESTED FOR RETURN. A REVIEW OF THE LOT HISTORY RECORD (LHR) INDICATED THAT THERE WERE NO NON-CONFORMANCES OBSERVED FOR THIS LOT AND THE LOT CONFORMS TO ITS PREDETERMINED SPECIFICATIONS AND REQUIREMENTS. A RISK ASSESSMENT REVIEW INDICATES THAT RESTENOSIS IS CAPTURED AS A FORESEEABLE EVENT. A REVIEW OF COBRA PZF INSTRUCTIONS FOR USE (IFU) WAS CONDUCTED. RESTENOSIS IS LISTED IN THE IFU AS A KNOWN POTENTIAL ADVERSE. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WITH RELEVANT ADDITIONAL INFORMATION WILL BE PROVIDED. THIS REPORT WAS RESUBMITTED AS "INITIAL" ONLY PER FDA REQUEST. NOTE THAT CODES IN H6 THAT CHANGED BETWEEN THE ORIGINAL 2018 INITIAL SUBMISSION AND THIS RE-SUBMISSION WERE OMMITED. SEE ORIGINAL REPORT FOR CODES IN USE AT THE TIME.

    Description of Event or Problem · 0

    A 78-YEAR-OLD MALE WITH MEDICAL HISTORY OF ATRIAL FIBRILLATION, DIABETES MELLITUS TYPE 2, HYPERLIPIDEMIA, AND HYPERTENSION WITH PRESERVED EJECTION FRACTION (EF=60%), PRESENTED WITH EVIDENCE OF ISCHEMIC HEART DISEASE ON (B)(6) 2018. CORONARY ANGIOGRAPHY SHOWED SEVERELY CALCIFIED OSTIAL TYPE C LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE PATIENT WAS ENROLLED IN THE COBRA REDUCE TRIAL AND WAS TREATED WITH PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH COBRA PZF NANOCOATED STENT (4X18 MM) IMPLANTED IN THE PROXIMAL RCA. ON (B)(6) 2018, THE PATIENT PRESENTED WITH EXERTION DYSPNEA WITHOUT ANGINA SYMPTOMS. THE SYMPTOMS SINCE THE STENT PCI ON (B)(6) 2018 HAVE NOT IMPROVED SIGNIFICANTLY. CARDIAC STRESS TEST WAS POSITIVE. FURTHER INVESTIGATION WITH CORONARY ANGIOGRAPHY ON (B)(6) 2018 SHOWED AN INTRA-STENT RESTENOSIS AT PROXIMAL RCA, WHICH WAS TREATED WITH DEPLOYMENT OF A DRUG-ELUTING STENT TO PROXIMAL RCA WITHOUT COMPLICATIONS. PER THE INVESTIGATOR, THE EVENT IS NOT RELATED TO THE INDEX PROCEDURE, BUT IS POSSIBLY RELATED TO THE STUDY DEVICE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803955 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 1707254001 00879397007479

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Hospitalization| R