BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA PZF

    MDR report key: 7987234 · Received October 19, 2018

    Report

    Report Number
    3009306400-2018-00074
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Date of Event
    September 20, 2018
    Report Date
    December 17, 2018
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    PMA / PMN Number
    160014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). VISUAL ANALYSIS WAS PERFORMED ON THE USED RETURNED DELIVERY SYSTEM. AS THE STENT WAS NOT RETURNED, STENT DAMAGE COULD NOT BE CONFIRMED. EVIDENCE OF PILLOW MARKS WERE OBSERVED ON THE UNCOVERED BALLOON AREA OF THE DELIVERY SYSTEM, CONFIRMING THAT THE STENT WAS CRIMPED TI THE BALLOON PRIOR TO THE EVENT. THE BALLOON WAS LOOSELY FOLDED, INDICATING THAT INFLATION OR DEPLOYMENT ATTEMPTS MAY HAVE BEEN MADE EITHER DURING USE OR POSSIBLY DUE TO INTENTIONAL MANIPULATION AFTER WITHDRAWAL FROM THE ANATOMY. THERE WERE MULTIPLE KINKS AND BENDS THAT APPEAR TO BE DUE TO INTENTIONAL MANIPULATION FOR PLACEMENT OF THE DEVICE INTO A SMALL BAG FOR RETURN SHIPMENT. DUE TO THE CONDITION OF THE RETURNED DEVICE, NO DIMENSIONAL MEASUREMENTS OR FUNCTIONAL ANALYSIS WERE ABLE TO BE PERFORMED. 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. A RISK ASSESSMENT REVIEW CONFIRMED THAT DISLODGEMENT IS CAPTURED AS A FORESEEABLE EVENT. A REVIEW OF RECEIVED ANGIOGRAPHY IMAGES WAS CONDUCTED BY CELONOVA MEDICAL AFFAIRS. SEVERE TORTUOSITY AND VESSEL DISEASE ARE VISUALIZED. GUIDELINER USE, PRE-DILATATION, AND STENTING OF THE PROXIMAL LCX WITH STENOSIS DISTAL TO THE STENT WERE ALL VISUALIZED, BUT THE REPORTED ADVANCEMENT DIFFICULTIES WERE UNABLE TO BE CONFIRMED. THE INVESTIGATION DETERMINED THAT WHILE A DEFINITIVE CONCLUSIVE CAUSE IS NOT ABLE TO BE ASSIGNED TO THE REPORTED COMPLAINT, THE REPORTED INABILITY TO CROSS WITH SUBSEQUENT STENT DAMAGE AND DISLODGEMENT OUTSIDE OF PATIENT ARE LIKELY ATTRIBUTED TO THE SEVERE VESSEL ANGULATION AS OTHER DEVICES WERE DIFFICULT TO ADVANCE AND ADDITIONAL LESION PREPARATION AND CROSSING SUPPORT CATHETER WERE EMPLOYED TO FACILITATE ADVANCEMENT ACROSS THE ANGULATION. 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

    SUBSEQUENT TO THE INITIAL FILED MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED, RESULTING IN THE FOLLOWING REVISED NARRATIVE: A (B)(6) MALE PATIENT WITH A MEDICAL HISTORY OF MULTI-VESSEL CORONARY ARTERY DISEASE, PRIOR CORONARY ARTERY BYPASS GRAFT (CABG) IN 2005, HYPERTENSION, DYSLIPIDEMIA, SEVERE RENAL INSUFFICIENCY, AND EX-SMOKER PRESENTED ON (B)(6) 2018 WITH ANGINA SYMPTOMS, AND ABNORMAL NUCLEAR STRESS TEST SHOWING LATERAL ISCHEMIA. THE PATIENT ENROLLED IN COBRA TRIAL. ANGIOGRAPHY ON (B)(6) 2018, SHOWED MULTI-VESSEL CORONARY ARTERY DISEASE WITH 95% STENOSIS IN THE SEVERELY TORTUOUS AND SEVERELY DISEASED PROXIMAL LEFT CIRCUMFLEX (LCX) CORONARY ARTERY. THE FIRST OBTUSE MARGINAL BRANCH HAD A 70% LESION NOTED. AFTER PRE-DILATING THE PROXIMAL LCX LESION, A 3.0X15MM COBRA PZF NANOCOATED CORONARY STENT SYSTEM WAS ADVANCED VIA RIGHT FEMORAL ACCESS, BUT WAS UNABLE TO CROSS AN ANGULATED VESSEL SEGMENT. ADDITIONAL PRE-DILATATION WAS PERFORMED AND A 6F GUIDELINER SUPPORT CATHETER WAS INTRODUCED FOR CROSSING SUPPORT. THE COBRA WAS THEN ABLE TO CROSS WITH THE STENT SUCCESSFULLY DEPLOYED WITH NO RESIDUAL STENOSIS IN THE STENTED SEGMENT THAT EXTENDED INTO LEFT MAIN. DISTAL TO THE STENT, THERE WAS A RESIDUAL 40% LESION NOTED. ATTEMPTS TO TREAT THAT AREA WITH A 3.0X08MM COBRA PZF WERE NOT SUCCESSFUL, SECONDARY TO SEVERE ANGULATION OF THE ARTERY. UPON WITHDRAWAL FROM PATIENT ANATOMY, STENT DAMAGE WAS NOTED AND, WHILE WIPING DOWN THE DEVICE, THE STENT INADVERTENTLY DISLODGED OUTSIDE OF THE BODY AND WAS NOT FOUND. ANOTHER 3.0X08MM COBRA PZF STENT WAS ADVANCED AND WAS UNABLE TO CROSS THE ANGULATED SEGMENT. IT WAS NOTED AFTER WITHDRAWAL FROM PATIENT ANATOMY THAT THE STENT WAS DAMAGED. THEREFORE, NO FURTHER ATTEMPTS WERE MADE TO TREAT THE SEGMENT JUST DISTAL TO THE FIRST STENT AS THERE WAS TIMI ILL FLOW AND NO DISSECTION SEEN. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IMPLANTED IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WITH ADDITIONAL RELEVANT INFORMATION WILL BE PROVIDED. THE OTHER COBRA PZFF STENT REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT WITH A MEDICAL HISTORY OF CORONARY ARTERY DISEASE, DIABETES MELLITUS TYPE II, HYPERTENSION, DYSLIPIDEMIA, LIVER DISEASE, AND EX-SMOKER PRESENTED ON (B)(6) 2018 WITH STABLE ANGINA. THE PATIENT ENROLLED IN COBRA REDUCE STUDY. ANGIOGRAPHY PERFORMED (B)(6) 2018 REVEALED A LESION IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) CORONARY ARTERY AND A LESION IN THE DISTAL LCX. AFTER INTRODUCING A 6F GUIDE CATHETER VIA RADIAL ACCESS, PRE-DILATATION WAS PERFORMED WITH A 3.0MM MEDTRONIC EUPHORA BALLOON, FOLLOWED BY DEPLOYMENT OF A 4.0X18MM COBRA PZF NANOCOATED STENT THEN A 4.0X24MM COBRA PZF STENT. POST STENT DEPLOYMENT, THERE WAS NO TIMI FLOW IN THE LCX. THE PATIENT EXPERIENCED CARDIAC ARREST DUE TO THROMBOSIS AND CORONARY ARTERY DISSECTION. A 4MM BALLOON WAS ADVANCED DOWN THE CIRCUMFLEX AND WAS INFLATED TO NOMINAL PRESSURE THROUGHOUT THE CIRCUMFLEX. THERE WAS NO IMPROVEMENT IN FLOW. THE PATIENT DEVELOPED VENTRICULAR TACHYCARDIA / VENTRICULAR FIBRILLATION (VF) AND WAS SHOCKED. THERE WAS NO RETURN OF PULSE. THE PATIENT DEVELOPED COARSE VF AND WAS SHOCKED SEVERAL TIMES. THE PATIENT EXPIRED THE SAME DAY. PER THE INVESTIGATOR, THIS EVENT IS POSSIBLY RELATED TO THE STUDY DEVICE AND THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827958 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 1710024002

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| R STENT: 4.0X18MM COBRA PZF