BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBRA PZF

    MDR report key: 10928104 · Received December 1, 2020

    Report

    Report Number
    3009306400-2020-00030
    Event Type
    Injury
    Date Received
    December 1, 2020
    Date of Event
    November 2, 2020
    Report Date
    January 15, 2021
    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

    H6 HEALTH IMPACT CODE: 4614 (WE WERE UNABLE TO ENTER THIS CODE IN H6 SECTION). THE STENT REMAINS IMPLANTED IN THE PATIENT. THE DELIVERY SYSTEM WAS REQUESTED, BUT WAS NOT PROVIDED. AS THE LOT NUMBER WAS NOT PROVIDED, LOT HISTORY REVIEW WAS UNABLE TO BE PERFORMED. ALL LOTS ARE SAMPLED AND MONITORED FOR STENT FORESHORTENING. STENT RECOIL / FORESHORTENING IS CAPTURED IN THE RISK ASSESSMENT AS A KNOWN POTENTIAL HAZARD. ALTHOUGH NO SUFFICIENT INFORMATION WAS PROVIDED TO DETERMINE THE CAUSE, IN GENERAL, CAUSES OF FORESHORTENING, MAY BE ATTRIBUTED TO INADEQUATE STENT EXPANSION DURING DEPLOYMENT, AND / OR VESSEL / LESION MORPHOLOGY / CHARACTERISTICS THAT CAN CONTRIBUTE TO STENT RECOIL. A MANUFACTURER REVIEW OF STENT FORESHORTENING SAMPLING DATA CONFIRMED THERE HAVE BEEN NO ADVERSE TRENDS OR OUT OF SPECIFICATION RESULTS. DEVICE CODING 2017: IT WAS REPORTED THAT THE COBRA STENT WAS IMPLANTED IN A SVG (SAPHENOUS VEIN BYPASS GRAFT). IT SHOULD BE NOTED THE INSTRUCTIONS FOR USE (IFU) STATE THE FOLLOWING, IN SECTION 6.4, PRECAUTIONS: LESION / VESSEL CHARACTERISTICS: 'SAFETY AND EFFECTIVENESS OF THE COBRA PZF NANOCOATED CORONARY STENT SYSTEM HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH LESIONS LOCATED IN SAPHENOUS VEIN GRAFTS.' DEVICE PROBLEM CODING 1494 IS ASSIGNED FOR PROBLEM ASSOCIATED WITH THE DEVICE WHICH HAS BEEN USED FOR AN UNAPPROVED INDICATION OR FOR AN UNAPPROVED INTENDED USE. 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

    IMMEDIATELY AFTER DEPLOYING A COBRA STENT IN A SVG (SAPHENOUS VEIN GRAFT), STENT RECOIL WAS OBSERVED IN REAL-TIME, ANGIOGRAPHICALLY. THE PHYSICIAN POST-DILATED THE COBRA WITH IMPROVED COVERAGE, BUT IS CONSIDERING DEPLOYING A 2ND STENT AT A LATER DATE DUE TO RESIDUAL RECOIL. THOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT ESTIMATED. DATE OF IMPLANT ESTIMATED. (B)(4). AS THE STENT REMAINS IMPLANTED IN THE PATIENT. THE DELIVERY SYSTEM WAS REQUESTED, BUT HAS NOT BEEN PROVIDED, TO DATE. AS THE LOT NUMBER WAS NOT PROVIDED, LOT HISTORY REVIEW WAS UNABLE TO BE PERFORMED. ALL LOTS ARE SAMPLED AND MONITORED FOR STENT FORESHORTENING; A REVIEW OF STENT FORESHORTENING SAMPLING DATA CONFIRMED THERE HAVE BEEN NO ADVERSE TRENDS OR OUT OF SPECIFICATION RESULTS. STENT RECOIL / FORESHORTENIN IS CAPTURED IN THE RISK ASSESSMENT AS A KNOWN POTENTIAL HAZARD. IT WAS REPORTED THAT THE COBRA STENT WAS IMPLANTED IN A SVG (SAPHENOUS VEIN BYPASS GRAFT). IT SHOULD BE NOTED THE INSTRUCTIONS FOR USE (IFU) STATE THE FOLLOWING, IN SECTION 6.4, PRECAUTIONS: LESION / VESSEL CHARACTERISTICS: *SAFETY AND EFFECTIVENESS OF THE COBRA PZF NANOCOATED CORONARY STENT SYSTEM HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH LESIONS LOCATED IN SAPHENOUS VEIN GRAFTS.* DEVICE PROBLEM CODING 1494 ASSIGNED FOR PROBLEM ASSOCIATED WITH THE DEVICE WHICH HAS BEEN USED FOR AN UNAPPROVED INDICATION OR FOR AN UNAPPROVED INTENDED USE. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WITH ADDITIONAL, RELEVANT INFORMATION RECEIVED WILL BE PROVIDED.

    Description of Event or Problem · 1

    IMMEDIATELY AFTER DEPLOYING A COBRA STENT IN A SVG (SAPHENOUS VEIN GRAFT), STENT RECOIL WAS OBSERVED IN REAL-TIME, ANGIOGRAPHICALLY. THE PHYSICIAN POST-DILATED THE COBRA WITH IMPROVED COVERAGE, BUT IS CONSIDERING DEPLOYING A 2ND STENT AT A LATER DATE DUE TO RESIDUAL RECOIL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN PROVIDED, TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395551 COBRA PZF STENT CORONARY DELIVERY SYSTEM MAF CELONOVA BIOSCIENCES, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention