BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA PZF

    MDR report key: 8197791 · Received December 26, 2018

    Report

    Report Number
    3009306400-2018-00083
    Event Type
    Malfunction
    Date Received
    December 26, 2018
    Date of Event
    October 19, 2018
    Report Date
    January 31, 2019
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397000685
    PMA / PMN Number
    160014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT REVISED. METHOD CODE 10 ADDED. RESULTS CODE 3233 REPLACED WITH 3207. CONCLUSION CODE 11 REPLACED WITH 4315. THE DEVICE WAS RECEIVED. DURING VISUAL INSPECTION ON 03-DEC-2018 IT WAS NOTED THAT THE STENT WAS SHIFTED DISTALLY AND WAS LOOSE ON THE BALLOON, BUT THE STENT REMAINED BETWEEN THE BALLOON MARKER BANDS AND WAS NOT ABLE TO BE PUSHED PAST THE DISTAL BALLOON MARKER. A REVIEW OF THE LOT HISTORY RECORD (LHR) WAS PERFORMED. THERE WERE NO NON-CONFORMANCES FOR THIS LOT. THE LOT CONFORMS TO ITS PREDETERMINED SPECIFICATIONS AND REQUIREMENTS, INCLUDING FOR CROSSING PROFILE AND STENT RETENTION. A COMPLAINTS RECORD REVIEW WAS CONDUCTED FOR THIS REPORTED PART & LOT COMBINATION. NO OTHER INCIDENTS WERE REPORTED FOR THIS PART & LOT COMBINATION. A RISK ASSESSMENT REVIEW CONFIRMED THAT THE REPORTED ADVANCEMENT DIFFICULTY AND LOOSE STENT ARE CAPTURED AS FORESEEABLE EVENTS. THE INVESTIGATION DETERMINED THAT WHILE A DEFINITIVE CONCLUSIVE CAUSE IS NOT ABLE TO BE ASSIGNED TO THE REPORTED COMPLAINT, THE REPORTED ADVANCEMENT DIFFICULTY AND BENT STRUT APPEAR TO BE RELATED TO PATIENT ANATOMY (MODERATELY TORTUOUS VESSEL WITH CHRONIC TOTAL OCCLUSION). POTENTIAL CAUSES OF RESISTANCE DURING ADVANCEMENT WITH RESULTANT STENT DAMAGE INCLUDE: DIFFICULT (CALCIFIED / TORTUOUS) ANATOMY; INCORRECT SELECTION OF STENT SYSTEM SIZE FOR REFERENCE VESSEL DIAMETER; STENT SYSTEM CROSSING PROFILE TOO LARGE; INSUFFICIENT PUSHABILITY, INSUFFICIENT COVERAGE OF, OR LACK OF, OR DEGRADATION OF, LUBRICITY COATING; DEFECT IN CATHETER BODY BOND; HANDLING DAMAGE; AND / OR DELIVERY SYSTEM TIP TOO LARGE. 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, A 79-YEAR-OLD FEMALE PATIENT PRESENTED WITH A NON-ST-ELEVATED MYOCARDIAL INFARCTION (NSTEMI). PERCUTANEOUS CORONARY INTERVENTION (PCI) OF A CHRONIC TOTAL OCCLUSION (CTO) IN THE MODERATELY TORTUOUS LEFT CIRCUMFLEX CORONARY ARTERY (LCX) WAS PERFORMED. DURING THE PCI, THE CTO WAS PRE-DILATED, THEN A 2.5X18MM COBRA PZF CORONARY STENT SYSTEM WAS ADVANCED VIA RIGHT RADIAL ACCESS BUT WAS UNABLE TO CROSS DUE TO PATIENT ANATOMY (CTO). THE PATIENT WAS ALTERNATIVELY TREATED VIA BALLOON ANGIOPLASTY (POBA). THE PATIENT WAS SCHEDULED TO RETURN FOR FUTURE PCI. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO SIGNIFICANT DELAY. THE DEVICE WAS RECEIVED BY CELONOVA BIOSCIENCES IN THE FOLLOWING CONDITION: THE STENT WAS SHIFTED DISTALLY AND WAS LOOSE ON THE BALLOON, BUT THE STENT REMAINED BETWEEN THE BALLOON MARKER BANDS AND WAS NOT ABLE TO BE PUSHED PAST THE DISTAL BALLOON MARKER. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED 19-OV-2018. DURING VISUAL INSPECTION ON 03-DEC-2018 IT WAS NOTED THAT THE STENT WAS SHIFTED DISTALLY AND WAS LOOSE ON THE BALLOON, BUT THE STENT REMAINED BETWEEN THE BALLOON MARKER BANDS AND WAS NOT ABLE TO BE PUSHED PAST THE DISTAL BALLOON MARKER. A REVIEW OF THE LOT HISTORY RECORD (LHR) WAS PERFORMED. THERE WERE NO NON-CONFORMANCE'S FOR THIS LOT. THE LOT CONFORMS TO ITS PREDETERMINED SPECIFICATIONS AND REQUIREMENTS, INCLUDING FOR CROSSING PROFILE AND STENT RETENTION. A RISK ASSESSMENT REVIEW CONFIRMED THAT THE REPORTED ADVANCEMENT DIFFICULTY AND LOOSE STENT ARE CAPTURED AS FORESEEABLE EVENTS. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WITH RELEVANT ADDITIONAL INFORMATION WILL BE SUBMITTED. WHILE CELONOVA BIOSCIENCES WAS MADE AWARE OF INABILITY TO CROSS ON (B)(6) 2018, THE LOOSE STENT WAS NOTED ON (B)(6) 2018; THUS, REPORTABILITY AWARE DATE IS (B)(6) 2018.

    Description of Event or Problem · 1

    ON (B)(6) 2018, A (B)(6) FEMALE PATIENT PRESENTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) OF AN UNSPECIFIED VESSEL. DURING PCI A 2.5X18MM COBRA PZF CORONARY STENT SYSTEM WAS ADVANCED BUT WAS UNABLE TO CROSS. THERE WERE NO ADVERSE PATIENT EFFECTS. THE DEVICE WAS RECEIVED BY CELONOVA BIOSCIENCES IN THE FOLLOWING CONDITION: THE STENT WAS SHIFTED DISTALLY AND WAS LOOSE ON THE BALLOON, BUT THE STENT REMAINED BETWEEN THE BALLOON MARKER BANDS AND WAS NOT ABLE TO BE PUSHED PAST THE DISTAL BALLOON MARKER. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036577 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 1709124002 00879397000685

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR