BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBRA PZF

    MDR report key: 8624780 · Received May 20, 2019

    Report

    Report Number
    3009306400-2019-00025
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    July 26, 2018
    Report Date
    August 22, 2019
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    UDI-DI
    00879397007257
    PMA / PMN Number
    P160014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    - H6 RESULTS CODE 3233 ADDED 10. - H6 CONCLUSION CODE 11 REPLACED WITH 4315 AND 22 THE DELIVERY SYSTEM WAS RECEIVED WITHOUT ITS STENT 25-APR-2019. FOLLOW-UP WITH THE SITE BUT NO ADDITIONAL INFORMATION PROVIDED. COMPLAINTS SPECIALIST PERFORMED VISUAL ANALYSIS ON THE USED RETURNED DELIVERY SYSTEM. COMPLAINTS SPECIALIST RECEIVED THE DELIVERY SYSTEM IN THE FOLLOWING CONDITION: THE GUIDEWIRE NOTCH WAS STRETCHED AND THE STENT WAS NOT RETURNED WITH THE DEVICE. THE BALLOON WAS LOOSE, INDICATING THAT INFLATION OR DEPLOYMENT ATTEMPTS MAY HAVE BEEN ATTEMPTED. DIMENSIONAL ANALYSIS ON THE RETURNED DEVICE MET PRODUCT SPECIFICATIONS. FUNCTIONAL ANALYSIS WAS NOT PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. COMPLAINTS SPECIALIST WAS UNABLE TO REPLICATE STENT DISLODGEMENT IN A TESTING ENVIRONMENT DUE TO THE CONDITION OF THE RETURNED DEVICE AND DUE TO PROCEDURAL, ANATOMICAL CIRCUMSTANCES, AND / OR OTHER UNCONTROLLED FACTORS POSSIBLY RELATED TO THE PROCEDURE ITSELF. A REVIEW OF THE LOT HISTORY RECORD (LHR) INDICATED THAT THERE WERE NO NON-CONFORMANCES OBSERVED FOR THIS LOT AND THE LOT CONFORMS TO ITS PREDETERMINED SPECIFICATIONS AND REQUIREMENTS, INCLUDING FOR STENT RETENTION. A RISK ASSESSMENT REVIEW INDICATES THAT DISLODGEMENT IS CAPTURED AS A FORESEEABLE EVENT. THE INVESTIGATION DETERMINED THAT WHILE A DEFINITIVE CONCLUSIVE CAUSE IS NOT ABLE TO BE ASSIGNED TO THE REPORTED COMPLAINT, THE REPORTED DIFFICULTIES ARE MOST LIKELY ATTRIBUTED TO CHALLENGING VESSEL / LESION 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) 2019, A STENT CAME OFF OF THE BALLOON OF A 2.5X18MM COBRA PZF NANOCOATED CORONARY STENT SYSTEM AT AN UNSPECIFIED POINT IN TIME DURING PERCUTANEOUS CORONARY INTERVENTION (PCI). THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THE DEVICE WAS RECEIVED 25 APR 2019 IN THE FOLLOWING CONDITION: THE STENT WAS NOT RETURNED, THE BALLOON WAS INFLATED (INDICATING POTENTIAL DEPLOYMENT ATTEMPT), AND BLOOD WAS NOTED ON THE DEVICE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IMPLANTED IN THE PATIENT. AS THE EVENT WAS REPORTED APPROXIMATELY 6 MONTHS AFTER THE STENT WAS IMPLANTED, AND THERE WAS NO REPORTED DEVICE MALFUNCTION, THE DEVICE WAS NOT REQUESTED FOR RETURN. A REVIEW OF THE LOT HISTORY RECORD (LHR) INDICATED THAT THERE WERE NO NON-CONFORMANCES OBSERVED FOR THIS LOT AND THE LOT CONFORMS TO ITS PREDETERMINED SPECIFICATIONS AND REQUIREMENTS. A RISK ASSESSMENT REVIEW INDICATES THAT MYOCARDIAL INFARCTION AND THROMBOSIS ARE CAPTURED AS FORESEEABLE EVENTS. A REVIEW OF COBRA PZF INSTRUCTIONS FOR USE (IFU) WAS CONDUCTED. MYOCARDIAL INFARCTION AND THROMBOSIS ARE LABELED IN THE IFU AS KNOWN POTENTIAL ADVERSE EVENTS. THE EXACT CAUSE OF THROMBOSIS (WITH MYOCARDIAL INFARCTION SYMPTOM) IS UNABLE TO BE DETERMINED. CAUSES OF THE ACUTE STENT THROMBOSIS CAN BE MULTI-FACTORIAL AND CAN INCLUDE PATIENT MEDICAL HISTORY AND COMORBIDITIES; NOT RESPONSIVE TO THE ANTIPLATELET THERAPY; VESSEL MORPHOLOGY; THROMBOGENIC VESSELS; INCREASE IN STENT SURFACE REACTIVITY; STENT THROMBOGENIC FOR PATIENT; STENT HEATED EXCESSIVELY BY MAGNETIC FIELD; STENT EXPANDED BEYOND DESIGN INTENT; STENT OVERSTRESSED LEADING TO FRACTURE, STENT IS UNDER UNDEREXPANDED. IN THIS CASE, THE RELATIONSHIP BETWEEN THE COBRA STENT AND THROMBOSIS CANNOT BE COMPLETELY RULED OUT. 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. THE THREE OTHER COBRA PZF STENTS (3.0X18MM AND 2X 2.5X18MM REFERENCED ARE BEING FILED UNDER SEPARATE MFR NUMBERS.

    Description of Event or Problem · 1

    AN (B)(6) MALE WITH MEDICAL HISTORY OF CORONARY ARTERY DISEASE WITH PERCUTANEOUS CORONARY INTERVENTION (PCI) ON (B)(6) 2011, ISCHEMIC CARDIOMYOPATHY, ATRIAL FLUTTER TREATED WITH ABLATION, AND ATRIAL FIBRILLATION S/P PACEMAKER, DIABETES MELLITUS TYPE 2, HYPERLIPIDEMIA, HYPERTENSION, RENAL IMPAIRMENT, AND FORMER SMOKER, PRESENTED WITH STABLE ANGINA. CORONARY ANGIOGRAPHY SHOWED MULTI VESSEL CORONARY ARTERY DISEASE. THE PATIENT WAS ENROLLED IN (B)(6) TRIAL ON (B)(6) 2018. PCI WAS PERFORMED WITH COBRA PZF¿ NANOCOATED STENT (3X18 MM) IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MLAD);TIMI FLOW 3 NOTED WITHOUT PROCEDURE COMPLICATION. THE PATIENT STARTED ON ASPIRIN ON (B)(6) 2018 AND WAS ON PLAVIX FROM (B)(6) 2017 TO (B)(6) 2018, AS WELL AS WARFARIN. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2018 FOR RECURRENT STABLE ANGINA SYMPTOMS. ANGIOGRAPHY ON (B)(6) 2018 SHOWED PATENT RCA AND 90-99% RESTENOSIS OF THE DISTAL PORTION OF THE COBRA STENT IN THE MID LAD WITH SEVERE D1 STENOSIS. PLANNED ANGIOGRAPHY WAS PERFORMED ON (B)(6) 2018 WITH SUCCESSFUL IMPLANTATION OF COBRA PZF¿ STENT (2.5X18 MM) TO D1, AND SUCCESSFUL IMPLANTATION OF COBRA PZF¿ STENT (2.5X18 MM) TO MLAD, AND IMPLANTATION OF A COBRA PZF¿ STENT (2.5X30) TO COVER DISSECTION IN MID TO DISTAL LAD. AFTER THE FINAL CORONARY ANGIOGRAPHY, THERE IS NO VISIBLE DISSECTION LINE. THE CORONARY FLOW IS NORMAL (TIMI 3). THAT SAME AFTERNOON ((B)(6) 2018), THE PATIENT HAD MYOCARDIAL INFARCTION (MI); ANGIOGRAPHY SHOWED PATENT MID LAD, AN ACUTE OCCLUSION BY THROMBUS OF THE DISTAL PART OF THE D1, AND OCCLUSION BY THROMBUS OF DISTAL LAD (DLAD). SUCCESSFUL BALLOON ANGIOPLASTY FOR D1 WAS PERFORMED, BUT IMPLANTATION OF A COBRA PZF¿ STENT (2.5X15) FAILED TO TREAT DLAD.. TIMI 0 FLOW WAS OBSERVED IN DISTAL LAD. SUBSEQUENT TNI INCREASED TO 7.9 NG/NL (31/07). ANTERO-APICAL LV DYSFUNCTION WITH EF 30% OBSERVED. THE ADMISSION WAS COMPLICATED BY HEMATEMESIS AND REQUIRED TWO UNITS OF BLOOD AND IV IRON INFUSION, FROM RENAL IMPAIRMENT, AND HYPOTENSION. THE PATIENT DISCHARGED HOME (B)(6) 2018. THE INVESTIGATOR INDICATED THE RECURRENT ANGINA WAS RELATED TO THE DEVICE AND NOT RELATED TO THE INDEX PROCEDURE. THE MI WAS REPORTEDLY RELATED TO THE INDEX PROCEDURE AND NOT TO THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED. THE SPONSOR ASSESSMENT: NEW LESION IN D1 WAS TREATED WITH COBRA STENT. INSTENT RESTENOSIS OF INDEX STENTS TREATED WITH BALLOON ANGIOPLASTY COMPLICATED WITH DISSECTION AND THROMBOSIS, WHICH WAS FURTHER TREATED WITH COBRA STENTS. THE PATIENT RETURNED THE SAME DAY TO THE CATH LAB WITH PATENT MID LAD STENT AND OCCLUSION IN THE DISTAL D1 AND DISTAL LAD DUE TO DISSECTION/ THROMBUS. THE FINAL RESULT WITH D1 PATENT, AND DISTAL LAD WITH TIMI 0 FLOW AT THE END OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418165 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. N/A 00879397007257

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention STENT: 3.0X18MM COBRA PZF.| STENTS: COBRA PZF (2X 2.5X18MM).| STENT: 3.0X18MM COBRA PZF| STENTS: COBRA PZF (2X 2.5X18MM)