BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA PZF

    MDR report key: 7930041 · Received October 3, 2018

    Report

    Report Number
    3009306400-2018-00068
    Event Type
    Malfunction
    Date Received
    October 3, 2018
    Date of Event
    July 18, 2018
    Report Date
    October 9, 2018
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397000944
    PMA / PMN Number
    160014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: METHOD CODE 10 ADDED. H6 RESULTS CODE 3233 REPLACED WITH 3207. CONCLUSION CODE 11 REPLACED WITH 4315. VISUAL AND FUNCTIONAL ANALYSIS WAS PERFORMED ON THE USED RETURNED DEVICE. LIFTED STRUT AT THE PROXIMAL END OF THE STENT WAS OBSERVED, AND THE STENT WAS SHIFTED DISTALLY ON THE BALLOON AND COVERING THE ENTIRE TIP. EVIDENCE OF PILLOW MARKS WERE OBSERVED ON THE UNCOVERED BALLOON AREA. THE BALLOON WAS TIGHTLY FOLDED, INDICATING THAT NO INFLATION OR DEPLOYMENT ATTEMPTS WERE MADE. DUE TO THE CONDITION OF THE RETURNED DEVICE, NO DIMENSIONAL MEASUREMENTS WERE ABLE TO BE PERFORMED. FUNCTIONAL ANALYSIS FOR GUIDE WIRE INSERTION WAS PERFORMED; THERE WAS NO RESISTANCE FELT AND NO STENT MOVEMENT OBSERVED DURING INSERTION. 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 FOR STENT RETENTION. THE INVESTIGATION DETERMINED THAT A DEFINITIVE CONCLUSIVE CAUSE IS NOT ABLE TO BE ASSIGNED TO THE REPORTED COMPLAINT. HOWEVER, GIVEN THAT THE DISTAL TARGET LESION WAS PRE-DILATED WITH A SMALLER DIAMETER BALLOON AND WAS ULTIMATELY TREATED WITH A SMALLER DIAMETER STENT, THE REPORTED RESISTANCE AND PARTIAL STENT DISLODGEMENT ARE LIKELY ATTRIBUTED TO THE INITIAL SELECTION OF A LARGER DIAMETER STENT AND / OR PATIENT'S VESSEL MORPHOLOGY. 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.

    Description of Event or Problem · 0

    ON (B)(6) 2018, THE PATIENT PRESENTED FOR TREATMENT OF A MILDLY CALCIFIED LESION IN THE NON-TORTUOUS MID RIGHT CORONARY ARTERY (RCA). AFTER PRE-DILATING THE LESION, A 4.0X30MM COBRA PZF NANOCOATED STENT SYSTEM WAS ADVANCED TO THE LESION WITHOUT DIFFICULTY, HOWEVER, THE PHYSICIAN REPORTED RESISTANCE IN THE MID SEGMENT OF THE STENT WHEN THE GUIDE WIRE PASSED THROUGH IT. IN ADDITION, THE PHYSICIAN HAD ALSO DECIDED TO TREAT A DISTAL LESION; THUS, THE PHYSICIAN DECIDED NOT TO USE THIS STENT SYSTEM AND IT WAS SUBSEQUENTLY WITHDRAWN WITHOUT DIFFICULTY. THE PHYSICIAN NOTICED WHAT APPEARED TO BE A POSSIBLE PROTRUDING DISTAL STRUT. A 3.5X24MM COBRA STENT WAS USED TO TREAT DISTAL SEGMENT AND A 4.0X24MM COBRA STENT WAS DEPLOYED TO MID RCA SEGMENT. THE PATIENT WAS NEVER AT RISK AND THERE WAS A GREAT OUTCOME. DURING START OF ANALYSIS OF THE RECEIVED DEVICE, IT WAS NOTED ON 04-SEP-2018 BY CELONOVA BIOSCIENCES THAT THE STENT WAS SHIFTED DISTALLY OVER THE BALLOON, PAST THE DISTAL TIP (PARTIAL DISLODGEMENT). ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN CONFIRMED THAT THE PARTIAL DISLODGEMENT VISUALIZED BY CELONOVA IS WHAT THE PHYSICIAN WAS REFERRING TO WHEN REPORTING THE PROTRUDING DISTAL STRUT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, BUT ANALYSIS IS NOT YET COMPLETE. 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 FOR STENT RETENTION. AS INVESTIGATION IS NOT YET COMPLETE, A FOLLOW-UP REPORT WITH RELEVANT ADDITIONAL INFORMATION WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE PATIENT PRESENTED FOR TREATMENT OF A MILDLY CALCIFIED LESION IN THE NON-TORTUOUS MID RIGHT CORONARY ARTERY (RCA), WITH NORMAL TAKE-OFF. AFTER PRE-DILATING THE LESION WITH A 3.0X20MM NON-COMPLIANT BALLOON, A 4.0X30MM COBRA PZF NANOCOATED STENT SYSTEM WAS ADVANCED TO THE LESION WITHOUT DIFFICULTY, BUT ADVANCEMENT REPORTEDLY FELT STRANGE / ODD (RESISTANCE WAS FELT ONLY IN THE MID SEGMENT OF THE STENT WHEN THE GUIDE WIRE PASSED THROUGH IT). IN ADDITION TO THE STRANGE FEELING, THE PHYSICIAN HAD ALSO DECIDED THAT A MORE DISTAL LESION NEEDED TREATMENT; THUS, THE PHYSICIAN DECIDED NOT TO USE THIS STENT SYSTEM AND IT WAS SUBSEQUENTLY WITHDRAWN WITHOUT DIFFICULTY, WHEN STENT WAS NOTED TO HAVE A PROTRUDING DISTAL STRUT. A 3.5X24MM COBRA STENT WAS USED TO TREAT DISTAL SEGMENT AND A NEW 4.0X24MM COBRA STENT WAS DEPLOYED TO MID RCA SEGMENT. REPORTEDLY, THE PATIENT WAS NEVER AT RISK AND THERE WAS A GREAT OUTCOME. DURING START OF ANALYSIS OF THE RECEIVED DEVICE, IT WAS NOTED ON (B)(6) 2018 BY CELONOVA BIOSCIENCES THAT THE STENT WAS SHIFTED DISTALLY OVER THE BALLOON, PAST THE DISTAL TIP (PARTIAL DISLODGEMENT). ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN CONFIRMED THAT THE PARTIAL DISLODGEMENT VISUALIZED BY CELONOVA IS WHAT THE PHYSICIAN WAS REFERRING TO WHEN REPORTING THE PROTRUDING DISTAL STRUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771884 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 1708284001 00879397000944

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR GUIDE CATHETER: MEDTRONIC (SIZE UNKNOWN)| GUIDE WIRE: ASAHI PROWATER (SIZE UNKNOWN)