BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBRA PZF

    MDR report key: 10432966 · Received August 20, 2020

    Report

    Report Number
    3009306400-2020-00023
    Event Type
    Injury
    Date Received
    August 20, 2020
    Date of Event
    July 10, 2020
    Report Date
    August 20, 2020
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397000746
    PMA / PMN Number
    P160014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES CONTINUED WITH ALL THERAPY DATES AS (B)(6) 2020: GUIDE WIRE: FIELDER XT. PRE-DILATATION BALLOONS: 2.5X12MM EMERGE, 2.5X12MM NC QUANTUM APEX. CUTTING BALLOON: WOLVERINE. SUPPORT CATHETER: GUIDELINER (SIZE UNKNOWN). THE STENT REMAINS IMPLANTED IN THE PATIENT AND THE DELIVERY SYSTEM WAS DISCARDED BY THE SITE. A REVIEW OF THE LOT HISTORY RECORD (LHR) WAS PERFORMED. THERE WERE NO NON-CONFORMANCES. THE LOT CONFORMS TO ITS PREDETERMINED SPECIFICATIONS AND REQUIREMENTS, INCLUDING FOR BALLOON FATIGUE TESTING. A REVIEW OF INSTRUCTIONS FOR USE CONFIRMED THAT BALLOON RUPTURE AND PERFORATION ARE LABELED AS A KNOWN POTENTIAL ADVERSE EVENTS. A REVIEW OF THE RECEIVED ANGIOGRAPHY IMAGES CONFIRMED THE REPORTED EXTRAVASATION. WHILE A DEFINITIVE ROOT CAUSE FOR THE REPORTED BALLOON RUPTURE AND PERFORATION ARE NOT ABLE TO BE DETERMINED WITH CERTAINTY, PATIENT HISTORY, COMORBIDITIES, AND CHALLENGING VESSEL AND LESION MORPHOLOGY ARE LIKELY CONTRIBUTING FACTORS. ADDITIONALLY, IT CANNOT BE STATED WITH CERTAINTY THAT BALLOON RUPTURE DID NOT CAUSE OR CONTRIBUTE TO PERFORATION. 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 · 1

    A (B)(6)-YEAR-OLD MALE PATIENT WITH MEDICAL HISTORY OF MULTI-VESSEL CORONARY ARTERY DISEASE, AND PRIOR ST-ELEVATED MYOCARDIAL INFARCTION (STEMI) TREATED VIA PERCUTANEOUS CORONARY INTERVENTION (PCI) OF NON-TARGET VESSEL, AND PANCREATIC CANCER RECENTLY DIAGNOSED WITH METASTATIS, PRESENTED (B)(6) 2020 FOR PLANNED PCI OF A SEVERELY CALCIFIED LESION IN THE VERY TORTUOUS PROXIMAL LEFT CIRCUMFLEX (LCX) CORONARY ARTERY. THE PATIENT RECEIVED 7000 UNITS HEPARIN TO ACHIEVE AN ACT OF GREATER THAN 300 SECONDS. AFTER ENGAGING A 4.0 GUIDING CATHETER VIA LEFT COMMON FEMORAL ACCESS, AN ATTEMPT WAS MADE TO CROSS THE LESION WITH A WHISPER GUIDE WIRE, BUT IT WAS UNABLE TO CROSS. A FIELDER XT WIRE WAS ABLE TO CROSS. PRE-DILATATION WAS PERFORMED WITH A 2.5 X 12 BALLOON AT 14 ATMOSPHERES (ATMS) FOR 2 INFLATIONS. OF NOTE, THE PROXIMAL CIRCUMFLEX DID HAVE SOME ANEURYSMAL ECTASIA. THERE WAS EVIDENCE OF A SIGNIFICANT STENOSIS DESPITE THE BALLOON INFLATION, SUGGESTING A RING OF CALCIUM. A CUTTING BALLOON WAS UNABLE TO CROSS; A GUIDELINER SUPPORT CATHETER WAS ADVANCED THEN ADDITIONAL DILATATION WAS PERFORMED USING A 2.5X12MM NON-COMPLIANT BALLOON, INFLATED TO 20 ATMS, WITH SATISFACTORY RESULT. A 2.75X18MM COBRA PZF¿ NANOCOATED CORONARY STENT SYSTEM WAS ADVANCED TO TARGET LESION. DURING STENT DEPLOYMENT, WHILE THE STENT WAS ABLE TO BE DEPLOYED IN THE TARGET LESION, THE BALLOON RUPTURED AT 14 ATMS. THOUGH UNABLE TO BE CONFIRMED, THE PHYSICIAN REPORTEDLY SUSPECTS BALLOON RUPTURE TYPE WAS A PINHOLE. EVIDENCE OF EXTRAVASATION INTO THE PERICARDIUM (FOCAL PERFORATION) WAS THEN OBSERVED AND THE PATIENT EXPERIENCED CHEST PAIN. A 2.5X28MM COVERED STENT WAS QUICKLY DEPLOYED, SUCCESSFULLY SEALING THE PERFORATION. INTRAVASCULAR ULTRASOUND (IVUS) SHOWED MODERATE OSTIAL CIRCUMFLEX STENOSLS THAT WAS ECCENTRIC WITH CALCIUM. THE STENT ITSELF APPEARED TO BE WELL EXPANDED PROXIMALLY; DISTALLY THERE WAS A STEP DOWN TO THE NATIVE VESSEL WHICH ITSELF HAD MILD DIFFUSE CALCIFIC DISEASE. DISTAL FLOW WAS TIMI 3 WITH NO DISSECTION AND NO EVIDENCE OF THROMBOSIS. THE PROCEDURE WAS CONCLUDED WITH NO ADDITIONAL INTERVENTION PERFORMED. AFTER 30 MINUTES HAD PASSED, ECHOCARDIOGRAM CONFIRMED THAT THERE WAS NO EVIDENCE OF PERICARDIAL EFFUSION. THERE WERE NO ADVERSE PATIENT SEQUELAE. IN THE OPINION OF THE TREATING PHYSICIAN, THE PERFORATION WAS DUE TO SEVERE CALCIUM. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895549 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 170-03-27518 1903084001 00879397000746

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention