BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA PZF

    MDR report key: 7542418 · Received May 24, 2018

    Report

    Report Number
    3009306400-2018-00013
    Event Type
    Malfunction
    Date Received
    May 24, 2018
    Date of Event
    March 15, 2018
    Report Date
    March 13, 2018
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397000913
    PMA / PMN Number
    P160014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL, DIMENSIONAL, AND FUNCTIONAL ANALYSIS WAS PERFORMED ON THE RETURNED DELIVERY SYSTEM; NO STENT WAS RETURNED. THE PROXIMAL SHAFT WAS SLIGHTLY BENT NEAR THE STRAIN RELIEF, WHICH MAY HAVE OCCURRED DUE TO DIFFICULTY CROSSING THE LESION AND/OR OCCURRED DURING REPACKAGING FOR RETURN SHIPMENT. BALLOON FOLDS WERE NOT TIGHTLY FOLDED AND THE BALLOON APPEARED TO BE FLATTENED, CONFIRMING THAT THE DEVICE WAS INFLATED TO DEPLOY THE STENT PARTIALLY AT THE INTENDED SITE, AS REPORTED. PILLOW/STENT MARKS WERE VISIBLE ON THE BALLOON, INDICATING THAT THE STENT WAS FIRMLY CRIMPED ON THE BALLOON BETWEEN THE MARKERS PRIOR TO SHIFTING OF STENT. MARKER BANDS WERE LOCATED BY BALLOON TAPERS AS SPECIFIED. FUNCTIONAL LEAK ANALYSIS CONFIRMED THAT NO LEAKS WERE PRESENT ANYWHERE ON THE DEVICE. THE RETURNED DEVICE DID NOT EXHIBIT MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE DISLODGEMENT. 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 CROSSING PROFILE AND STENT RETENTION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE FILED WITH ADDITIONAL RELEVANT INFORMATION. THE OTHER 4.015MM COBRA PZF STENT MENTIONED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    ON (B)(6) 2018, AN (B)(6)-YEAR-OLD FEMALE PRESENTED WITH ANGINA AND NON-ST-ELEVATED MYOCARDIAL INFARCTION AND DIAGNOSED WITH SINGLE-VESSEL DISEASE IN THE DISTAL RIGHT CORONARY ARTERY (RCA). DURING PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE TO TREAT THE 80% STENOSED, MILDLY CALCIFIED LESION IN THE DISTAL RCA VIA RIGHT FEMORAL ACCESS, AN ATTEMPT WAS MADE TO CROSS THE LESION USING A 4.0X15MM COBRA PZF NANOCOATED CORONARY STENT SYSTEM, WITHOUT PRE-DILATATION, BUT IT WAS UNABLE TO CROSS THE LESION. THE COBRA WAS WITHDRAWN AND THE LESION WAS THEN DILATED USING A 3.0X12MM BALLOON. THE 4.0X15MM COBRA WAS THEN RE-INSERTED, BUT WAS STILL UNABLE TO REACH THE LESION. UPON WITHDRAWAL, IT WAS DISCOVERED THAT THE STENT WAS NOT ON ITS DELIVERY SYSTEM. THE DISLODGED STENT WAS FOUND IN A MILDLY CALCIFIED LESION IN THE PROXIMAL RCA; THOUGH NO TREATMENT WAS PLANNED FOR THIS PROXIMAL RCA LESION, THE COBRA BALLOON WAS RE-ADVANCED TO DEPLOY THE DISLODGED STENT IN THE PROXIMAL RCA, FOLLOWED BY POST-DILATATION WITH THIS SAME BALLOON. THE DISTAL RCA LESION WAS THEN PRE-DILATED AGAIN. A 5.5FR GUIDELINER WAS THEN ADVANCED TO THE PROXIMAL PORTION OF THE DISTAL RCA LESION TO ASSIST WITH CROSSING, FOLLOWED BY ADVANCEMENT OF A NEW 4.0X15MM COBRA PZF NANOCOATED CORONARY STENT SYSTEM; DURING ADVANCEMENT, THE STENT BEGAN TO COME OFF OF THE BALLOON, BUT WAS ABLE TO PARTIALLY CROSS THE LESION WITH THE STENT DEPLOYED SLIGHTLY PROXIMAL OF THE INTENDED DEPLOYMENT SITE, FOLLOWED BY POST-DILATATION. THE PROCEDURE WAS SUCCESSFULLY CONCLUDED WITH TIMI FLOW 3 AND EXCELLENT ANGIOGRAPHIC RESULTS. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385894 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 170-03-40015 1707204001 00879397000913

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female GUIDE CATHETER: 6FR JR4| GUIDE WIRE: 0.014X190CM BALANCE| STENT: 4.0X15MM COBRA PZF| SUPPORT CATHETER: 5.5FR GUIDELINER