BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBRA PZF

    MDR report key: 6945908 · Received October 12, 2017

    Report

    Report Number
    3009306400-2017-00012
    Event Type
    Injury
    Date Received
    October 12, 2017
    Date of Event
    April 4, 2017
    Report Date
    December 7, 2017
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    PMA / PMN Number
    P160014
    Removal / Correction Number
    NONE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: AS THE STENT REMAINS IMPLANTED IN THE PATIENT AND THERE WAS NO REPORT OF A DEVICE MALFUNCTION, IT WAS NOT REQUESTED FOR RETURN. A REVIEW OF THE LOT HISTORY RECORD REVEALED THAT THERE WERE NO NON-CONFORMANCES RELATED TO THE REPORTED DIFFICULTIES FOR THIS LOT AND A RISK ASSESSMENT REVIEW CONFIRMED THAT DISSECTION IS CAPTURED AS A FORESEEABLE EVENT. ADDITIONALLY, DISSECTION IS LABELED IN THE INSTRUCTIONS FOR USE AS A KNOWN POTENTIAL ADVERSE EVENT. CINE IMAGES WERE RECEIVED AND REVIEWED; WHILE THE REVIEW SUPPORTS THE OCCURRENCE OF THE SUBSEQUENT DIAGNOSTIC ANGIOGRAPHY AND DIFFICULTY CROSSING ON (B)(6) 2017, NO INDEX PROCEDURE IMAGES WERE RECEIVED, THUS, NO ANGIOGRAPHIC CONCLUSION WAS ABLE TO BE MADE REGARDING THE INDEX PROCEDURE WITH THE COBRA DEVICE. WHILE THE INVESTIGATOR BELIEVES THAT ANGINAL SYMPTOMS WITH MILD TROPONIN ELEVATION IS NOT RELATED TO THE DEVICE OR THE PROCEDURE AND THE SPONSOR AGREES, A RELATIONSHIP BETWEEN THE COBRA DEVICE AND THE DISSECTION COULD NOT BE 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.

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT IS ESTIMATED. ONLY BIRTH YEAR OF (B)(6) WAS REPORTED. THE STENT REMAINS IMPLANTED IN THE PATIENT AND THERE IS NO COMPLAINT AGAINST THIS DELIVERY SYSTEM; THUS, THE DEVICE WAS NOT RETURNED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE FILED WITH SIGNIFICANT, RELEVANT ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL FILED MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED RESULTING IN THE FOLLOWING REVISED EVENT DESCRIPTION: ON (B)(6) 2017, A (B)(6) YEAR-OLD MALE WITH MEDICAL HISTORY OF CORONARY ARTERY DISEASE, ATRIAL FIBRILLATION, SYSTEMIC LUPUS ERYTHEMATOSUS AND DIASTOLIC HEART FAILURE GRADE 1 PATIENT PRESENTED WITH ANGINA SYMPTOMS. CARDIAC CATHETERIZATION REVEALED SEVERELY CALCIFIED STENOSIS IN 1ST DIAGONAL (D1) CORONARY ARTERY. AFTER CROSSING THE LESION WITH GUIDEWIRE, THE PATIENT WAS ENROLLED IN COBRA TRIAL AND RANDOMIZED TO COBRA PZF STENT. ATTEMPTS TO PRE-DILATE THE TARGET LESION WERE NOT SUCCESSFUL, AND THE PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS STOPPED. ON (B)(6) 2017, THE PATIENT PRESENTED WITH RECURRENT ANGINAL SYMPTOMS. PCI WAS THEN PERFORMED (B)(6) 2017 WITH SUCCESSFUL DILATATION OF THE LESION. A 2.5X18 MM COBRA PZF STENT WAS DEPLOYED IN THE PROXIMAL D1. A DISTAL DISSECTION OF THE VESSEL OCCURRED. ATTEMPTS TO ADVANCE A 2ND COBRA STENT TO COVER THE DISSECTION FAILED DUE TO MASSIVE FRICTION FROM THE STENT AND CALCIFICATION. HOWEVER, A DRUG-ELUTING STENT (DES) WAS SUCCESSFULLY IMPLANTED TO TREAT THE DISSECTION AND THE PATIENT WAS DISCHARGED. ON (B)(6) 2017, THE SYMPTOMS RECURRED WITH RADIATING CHEST PAIN AND MILD TROPONIN ELEVATION. THE PATIENT WAS HOSPITALIZED AND DIAGNOSED WITH UNSTABLE ANGINA. ON (B)(6) 2017, CORONARY ANGIOGRAPHY WITHOUT INTERVENTION SHOWED GOOD RESULT IN THE PROXIMAL D1, AND SHOWED REMAINING STENOSIS IN DISTAL D1. DUE TO THE MULTIPLE UNSUCCESSFUL PCI ATTEMPTS, DUE TO SMALL VESSEL DIAMETER, AND DUE TO DIFFICULT GUIDEWIRE ADVANCEMENT, NO FURTHER PCI ATTEMPTS WERE MADE. CONSERVATIVE ANTIANGINAL MEDICAL TREATMENT INITIATED. PATIENT DISCHARGED WITHOUT COMPLICATION ON (B)(6) 2017. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE REPORTED DISSECTION WAS NOT FLOW-LIMITING. THE DES STENT DEPLOYED DURING THE INDEX PROCEDURE TREATED THE DISSECTION. ADDITIONALLY, THE ANGINAL SYMPTOMS WITH MILD TROPONIN ELEVATION THAT HAD REPORTEDLY OCCURRED (B)(6) 2017 WAS CONFIRMED BY THE INVESTIGATOR TO BE UNRELATED TO THE COBRA STENT. THE SPONSOR AGREES WITH THE INVESTIGATOR THAT THESE SYMPTOMS ARE UNRELATED TO STUDY DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2017, A (B)(6) MALE PATIENT PRESENTED WITH ANGINA AND WAS ENROLLED IN THE (B)(6) STUDY. ON (B)(6) 2017, A 2.5X18MM COBRA PZF STENT (LOT# 1602044001) WAS DEPLOYED VIA RADIAL ACCESS IN THE HIGH-GRADE CALCIFIED, STENOSED 1ST DIAGONAL ARTERY, BUT A DISTAL DISSECTION RESULTED. AN ATTEMPT WAS MADE TO PLACE A 2.5X18MM COBRA PZF STENT (LOT# 1602044001), BUT IT WAS UNABLE TO CROSS DUE TO MASSIVE FRICTION FELT AGAINST THE 1ST IMPLANTED COBRA AND AGAINST THE LESION CALCIFICATION. A XIENCE DES STENT WAS IMPLANTED, COVERING THE LESION. THE PATIENT WAS DISCHARGED. ON (B)(6) 2017, THE PATIENT BEGAN EXPERIENCING SEVERE THORACIC PAIN THAT RADIATED TO THE LEFT ARM, LASTING FOR 3 DAYS, AND PRESENTED WITH UNSTABLE ANGINA AND ELEVATED TROPONIN (0.023NG/ML) LEVELS. THE PATIENT WAS RE-HOSPITALIZED. ON (B)(6) 2017, CORONARY ANGIOGRAPHY SHOWED GOOD RESULT IN THE PROXIMAL 1ST DIAGONAL, AND A KNOWN STENOSIS IN THE DISTAL 1ST DIAGONAL. AN ATTEMPT WAS MADE TO PERFORM DIAGNOSTIC LEFT HEART CATHETERIZATION OF THE 1ST DIAGONAL TO FURTHER DETERMINE THE CAUSE OF SYMPTOMS, BUT THE DIAGNOSTIC CATHETERIZATION ATTEMPTS WERE ENDED FOR THE FOLLOWING REASONS: A WIRE COULD ONLY CROSS WITH DIFFICULTY; THE PRIOR INTERVENTION ATTEMPT WAS DIFFICULT AND RESULTED IN DISSECTION, AS REPORTED; AND VESSEL DIAMETER WAS SMALL. A RELATIONSHIP BETWEEN THE SYMPTOMS AND THIS VESSEL WAS UNABLE TO BE CONFIRMED. NO FURTHER DIAGNOSTIC ATTEMPTS WERE MADE. THE PATIENT WAS TREATED NITROGLYCERIN MEDICATION AND DISCHARGED THE FOLLOWING DAY IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724143 COBRA PZF STENT CORONARY DELIVERY SYSTEM, PRODUCT CODE MAF CELONOVA BIOSCIENCES, INC. 1602044001

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention