BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBRA PZF

    MDR report key: 7096551 · Received December 7, 2017

    Report

    Report Number
    3009306400-2017-00016
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    November 10, 2017
    Report Date
    February 15, 2018
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Product Code
    MAF
    PMA / PMN Number
    P160014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE REMAINS IMPLANTED IN THE PATIENT AND THERE WAS NO COMPLAINT AGAINST THE DELIVERY SYSTEM, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE FINISHED STENT DELIVERY SYSTEM LOT HISTORY RECORD (LHR), AND, IN PARTICULAR, A REVIEW OF THE RECEIVING INSPECTION REPORT FOR THE STENT LOTS WERE CONDUCTED,. THERE WERE NO NON-CONFORMANCES THAT OCCURRED RELATED TO THE REPORTED COMPLAINT, AND DATA CONFIRMED THAT THE RAW MATERIALS AND FINISHED STENTS FROM THIS LOT CONFORM TO THEIR PREDETERMINED SPECIFICATIONS. A RISK ASSESSMENT DOCUMENT REVIEW CONFIRMED THAT STENT FRACTURE IS LISTED AS A POTENTIAL HAZARD. A REVIEW OF THE CELONOVA BIOSCIENCES COMPLAINT HANDLING SYSTEM REVEALED THAT THIS IS THE ONLY STENT FRACTURE-RELATED COMPLAINT REPORTED FOR A COBRA DEVICE SINCE COMMERCIAL RELEASED IN DEC 2012. A REVIEW OF RECEIVED CINE AND IVUS IMAGES WAS PERFORMED BY CELONOVA MEDICAL AFFAIRS AND STUDY CORE LAB, WITH THE FOLLOWING RESULTS: WHILE AN UNIDENTIFIABLE, FAINT LONGITUDINAL, ACCORDION-SHAPED ARTIFACT WAS VISUALIZED IN THE CENTER OF THE STENT, A DEFINITIVE FRACTURE WAS UNABLE TO BE VISUALIZED AND, THUS, UNABLE TO BE CONFIRMED WITH CERTAINTY; THIRD-PARTY CLINICAL AFFILIATES CONCURRED WITH THIS ASSESSMENT. THE INVESTIGATION DETERMINED THAT THE STENT FROM THIS LOT MET ITS PREDETERMINED SPECIFICATIONS, THE STENT WAS REPORTEDLY NOT EXPANDED BEYOND ITS MAXIMUM INFLATION CAPACITY (DEPLOYED AT 15 ATM), A STENT FRACTURE WAS UNABLE TO BE CONFIRMED, AND THIS IS THE FIRST STENT FRACTURE RELATED COMPLAINT REPORTED TO CELONOVA BIOSCIENCES. HOWEVER, THE POSSIBILITY OF A PARTIAL FRACTURE COULD NOT 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.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL FILED MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED RESULTING IN THE FOLLOWING REVISED EVENT NARRATIVE: A (B)(6) MALE WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE WITH PERCUTANEOUS CORONARY INTERVENTION (PCI) IN 2016, ATRIAL FIBRILLATION (ON ORAL ANTICOAGULANT), DIABETES MELLITUS TYPE I, HYPERTENSION, HEART FAILURE WITH REDUCED EJECTION FRACTION (EF=25%), AND RENAL INSUFFICIENCY PRESENTED ON 10 NOVEMBER 2017 WITH EVIDENCE OF MYOCARDIAL ISCHEMIA. THE PATIENT WAS ENROLLED IN COBRA TRIAL. AN ELECTROCARDIOGRAM (ECG) SHOWED ATRIAL FIBRILLATION. DIAGNOSTIC ANGIOGRAPHY SHOWED A LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA) AND A LESION IN THE DISTAL CIRCUMFLEX (CX) CORONARY ARTERY. PCI WAS PERFORMED WITHOUT PRE-DILATATION WITH A COBRA PZF STENT (3.5X18MM) IMPLANTED AT 15 ATMOSPHERES (ATM) IN THE RCA LESION, AND A COBRA PZF STENT (3.5X24MM) IMPLANTED AT 14 (ATM) IN THE CX. NO POST-DILATATION WAS PERFORMED. INTRAVASCULAR ULTRASOUND (IVUS) SHOWED STENOSIS REDUCTION AND REPORTEDLY SHOWED PARTIAL FRACTURE AT THE PROXIMAL END OF THE STENT IN THE RCA. HOWEVER, A REVIEW OF RECEIVED ANGIOGRAPHIC IMAGES SHOWED NO EVIDENCE OF PARTIAL STENT FRACTURE. ANOTHER COBRA PZF STENT (3.5X24 MM) WAS DEPLOYED IN THE RCA TO COVER THE PARTIALLY FRACTURED STENT. THERE WERE NO ADVERSE PATIENT SEQUELAE, AND NO COMPLICATION REPORTED.

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS ESTIMATED AS ONLY YEAR OF BIRTH IS GIVEN AS (B)(6). THE STENT REMAINS IMPLANTED IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WITH ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED.

    Description of Event or Problem · 1

    (B)(6)-YEAR-OLD MALE WITH A PAST MEDICAL HISTORY OF CORONARY ARTERY DISEASE WITH PERCUTANEOUS CORONARY INTERVENTION (PCI) IN 2016, ATRIAL FIBRILLATION (ON ORAL ANTICOAGULANT), DIABETES MELLITUS TYPE I, HYPERTENSION, HEART FAILURE WITH REDUCED EJECTION FRACTION (EF= 25%), AND RENAL INSUFFICIENCY PRESENTED ON (B)(6) 2017 WITH EVIDENCE OF MYOCARDIAL ISCHEMIA. THE PATIENT WAS ENROLLED IN COBRA TRIAL. AN ELECTROCARDIOGRAM (ECG) SHOWED ATRIAL FIBRILLATION. DIAGNOSTIC ANGIOGRAPHY SHOWED A LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA) AND A LESION IN THE DISTAL CIRCUMFLEX (CX) CORONARY ARTERY. PCI WAS PERFORMED WITHOUT PRE-DILATATION WITH A COBRA PZF STENT (3.5X18MM ) IMPLANTED AT 15 ATMOSPHERES (ATM) IN THE RCA LESION, AND A COBRA PZF STENT (3.5X24MM) IMPLANTED AT 14 (ATM) IN THE CX. NO POST-DILATATION WAS PERFORMED. INTRAVASCULAR ULTRASOUND (IVUS) SHOWED STENOSIS REDUCTION AND REPORTEDLY SHOWED PARTIAL FRACTURE AT THE PROXIMAL END OF THE STENT IN THE RCA. HOWEVER, A REVIEW OF RECEIVED ANGIOGRAPHIC IMAGES SHOWED NO EVIDENCE OF STENT FRACTURE. ANOTHER COBRA PZF STENT (3.5X24 MM) WAS DEPLOYED IN THE RCA TO COVER THE FRACTURED STENT. THERE WERE NO ADVERSE PATIENT SEQUELAE, AND NO COMPLICATION REPORTED. THE SPONSOR REQUESTED IVUS IMAGING FOR REVIEW AND FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874518 COBRA PZF STENT DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. 1612204002

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention STENT: 3.5X24MM COBRA PZF| STENT: 3.5X24MM COBRA PZF