BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBRA PZF

    MDR report key: 8139407 · Received December 6, 2018

    Report

    Report Number
    3009306400-2018-00071
    Event Type
    Injury
    Date Received
    December 6, 2018
    Date of Event
    August 9, 2018
    Report Date
    October 18, 2018
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    PMA / PMN Number
    160014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE STENT REMAINS IMPLANTED IN THE PATIENT. THE DELIVERY SYSTEM WAS REQUESTED, BUT HAS NOT BEEN RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WITH ADDITIONAL RELEVANT INFORMATION WILL BE PROVIDED. THE 1ST 4.0X15MM AND THE 4.0X18MM COBRA MENTIONED IN B5 AND D11 ARE BEING FILED UNDER SEPARATE MANUFACTURER REPORT NUMBERS. 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

    AN 85-YEAR-OLD MALE PARTICIPATING IN THE CELONOVA COBRA REDUCE TRIAL, PRESENTED WITH A RELEVANT MEDICAL HISTORY OF CORONARY ARTERY DISEASE, SEVERE MITRAL INSUFFICIENCY, SEVERE TRICUSPID INSUFFICIENCY, PERIPHERAL ARTERIAL DISEASE, PULMONARY ARTERIAL HYPERTENSION, AND CHRONIC OBSTRUCTIVE AIRWAYS DISEASE. THE SUBJECT'S CONCOMITANT MEDICATIONS INCLUDE: WARFARIN, ASPIRIN, AND CLOPIDOGREL. THE PATIENT WAS HOSPITALIZED FROM (B)(6) AUGUST 2018 FOR INCREASING SHORTNESS OF BREATH. THE PATIENT UNDERWENT CORONARY ANGIOGRAPHY ON (B)(6) 2018, WHICH SHOWED A VERY TIGHT SEVERELY CALCIFIED STENOSIS OF THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. AFTER ALLOCATION TO TREATMENT WITH THE COBRA PZF NANOCOATED CORONARY STENT SYSTEM, AN ATTEMPT WAS MADE TO DIRECTLY STENT THE PROXIMAL LAD LESION VIA RADIAL ACCESS WITH A 4.0 X 15MM COBRA PZF (REF 170-01-40015; LOT 1703234001). IT WAS NOT POSSIBLE TO ADVANCE THE STENT ACROSS THE LEFT MAIN ARTERY (LEFT MAIN WAS TOO TIGHT) TO REACH THE TARGET PROXIMAL LAD LESION; THE STENT WAS WITHDRAWN AND IT WAS DEPLOYED IN THE LEFT MAIN CORONARY ARTERY (LMCA) AND POST-DILATED WITH A NC EUPHORA BALLOON (5 X 15 MM AT 18 ATM). THE PROXIMAL LAD LESION WAS THEN PRE-DILATED WITH A TREK BALLOON (2.5 X 8 MM AT 14 ATM) FOLLOWED BY A TREK 3.0 X 12 MM BALLOON AT 14 ATM. DESPITE LESION PREPARATION, A SECOND 4.0 X 15MM COBRA PZF (REF 170-01-40015; LOT 1703234001) COULD NOT BE ADVANCED ACROSS THE LESION AND WAS AGAIN WITHDRAWN AND THEN WAS ALSO DEPLOYED IN THE LMCA AND POST-DILATED WITH A NC EUPHORA BALLOON (5 X 15 MM AT 18 ATM). A COBRA PZF 4.0 X 18 MM (REF 170-01- 40018; LOT 1705014001) COULD NOT BE ADVANCED ACROSS THE TARGET LESION AND WAS DEPLOYED IN THE OSTIAL LAD AND POST-DILATED WITH A NC EUPHORA BALLOON (4 MM AT 20 ATM). THE TARGET LESION WAS PRE-DILATED WITH A NC EUPHORA BALLOON (4.5 MM AT 20 ATM). TWO OTHER ATTEMPTS WITH COBRA PZF STENTS (4.0 X 15 MM AND 3.5 X 15 MM) WERE UNSUCCESSFUL. FINALLY, THE PHYSICIAN DEPLOYED A DES STENT 3.5 X 15 MM ACROSS THE LESION (18 ATM) SUCCESSFULLY. IN SUMMARY, 5 COBRA PZF STENT DEVICES COULD NOT BE ADVANCED ACROSS THE TARGET LESION, RESULTING IN DEPLOYMENT OF 3 STENTS IN NON-TARGET LOCATIONS AND WITHDRAWAL OF 2 STENTS FROM THE BODY, FOLLOWED BY SUCCESSFUL TREATMENT WITH AN ALTERNATIVE DEVICE. THIS INEVITABLY RESULTED IN PROLONGATION OF THE PROCEDURE. DURING THE HOSPITALIZATION, THE PATIENT TROPONIN MILDLY ELEVATED TO 0.836 ON (B)(6) 2018 AND WAS DOWN TO 0.288 ON 11 AUGUST 2018 WITH ST SEGMENT DEPRESSION ON ECG. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980263 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 1703234001

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Life Threatening| R 4 STENTS: COBRA 4.0X15, 4.0X18MM, 4.0X15MM, 3.5X15| GUIDE CATHETER: 6F MEDTRONIC EBU 3.5| GUIDE WIRE: 0.014 SPORT EXTRA| SUPPORT CATHETER: HEARTRAIL -IMPOSSIBLE TO ADVANCE