BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 10255758 · Received July 9, 2020

    Report

    Report Number
    2024168-2020-05650
    Event Type
    Injury
    Date Received
    July 9, 2020
    Date of Event
    June 16, 2020
    Report Date
    August 10, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAF
    UDI-DI
    08717648176418
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. IT SHOULD BE NOTED THAT THE GRAFTMASTER RAPID EXCHANGE (RX), CORONARY STENT GRAFT SYSTEM, DOMESTIC, INSTRUCTIONS FOR USE, (IFU) STATES: THE GRAFTMASTER RX IS INDICATED FOR USE IN THE TREATMENT OF FREE PERFORATIONS, DEFINED AS FREE CONTRAST EXTRAVASATION INTO THE PERICARDIUM, IN NATIVE CORONARY VESSELS OR SAPHENOUS VEIN BYPASS GRAFTS GREATER THAN OR EQUAL TO 2.75 MM IN DIAMETER. IT WAS REPORTED THAT THE GRAFTMASTER WAS USED PAST THE EXPIRATION DATE. THE EXPIRATION DATE OF THE PRODUCT IS IMPORTANT FOR STERILITY, EFFICACY, AND PERFORMANCE OF THE DEVICE. IT SHOULD BE NOTED THAT THE GRAFTMASTER RAPID EXCHANGE RX CORONARY STENT GRAFT SYSTEM IFU STATES: NOTE THE PRODUCT USE BY DATE SPECIFIED ON THE PACKAGE. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED MATERIAL DEFORMATION AND DIFFICULT TO ADVANCE OVER THE GUIDEWIRE. THE REPORTED DEVICE EXPIRATION ISSUE APPEARS TO BE RELATED TO THE USE ERROR. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE 2.8X19MM AND 4.0X19MM GRAFTMASTER DEVICES REFERENCED ARE FILED UNDER A SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED WITH A PROPER HEPATIC ARTERY BLEEDING PSEUDOANEURYSM WITH HEMATOBILIA AND A TRANSPLANTED LIVER. AN ARTERIAL THROMBOSIS FROM THE COMMON HEPATIC ARTERY FOR PERSISTENT THROMBUS WITHIN THE PROPER HEPATIC ARTERIAL UNSPECIFIED STENT, THROUGHOUT THE DISTAL PROPER HEPATIC ARTERY, AND PERSISTENT OCCLUSION OF THE RIGHT HEPATIC ARTERY. COIL EMBOLIZATION WAS PERFORMED WITHIN THE GASTRODUODENAL ARTERY (GDA) AND MICROCATHETER ADVANCED. A 2.8X19MM GRAFTMASTER (GM) STENT (1012580-19, 8051141--EXPIRED) WAS IMPLANTED. NO FURTHER EXTRAVASATION WAS OBSERVED. POST-PROCEDURE IMAGING WAS PERFORMED AND THE 2.8X19MM GM STENT HAD OCCLUDED WITH THROMBUS. IT IS UNKNOWN IF THIS THROMBUS WAS PER-EXISTING. MEDICATION WERE PROVIDED AND ANOTHER CATHETERIZATION WAS PERFORMED THAT SAME DAY TO INFUSE PERCUTANEOUS THROMBOLYTICS OVERNIGHT. ON (B)(6) 2020, THE PATIENT PRESENTED WITH PROPER HEPATIC ARTERY HEMORRHAGE FROM THE SAME SITE, UNKNOWN IF THE 2.8X19MM GM STENT HAD FAILED TO SEAL. THE RIGHT HEPATIC ARTERY STENOSIS WAS TREATED WITH BALLOON ANGIOPLASTY AND ANGIOPLASTY WAS PERFORMED THROUGHOUT THE OCCLUDED GM STENT. A 3.5X26MM GRAFTMASTER (1012581-26, 8031641-EXPIRED) ADVANCED, HOWEVER, HAD DIFFICULTY ADVANCING/TRACKING OVER THE UNSPECIFIED GUIDEWIRE. THE DEVICE WAS REMOVED WITHOUT ISSUE. ONCE OUT OF THE ANATOMY, THE STENT APPEARED ¿ROUGH AND SHARP¿. ANOTHER DEVICE WAS USED IN REPLACEMENT. IN REPLACEMENT, THE 3.5X19MM GRAFTMASTER STENT (1012581-19, 9032941¿NOT EXPIRED) AND 4.0X19MM GRAFTMASTER (1012582-19, 8051041-EXPIRED) STENTS WERE PROPERLY IMPLANTED, SEALING THE AREAS OF EXTRAVASATION. BOTH STENTS WERE NEEDED TO SEAL THE PERFORATION DUE TO THE PERFORATION SIZE. THERE WAS NO STENT LEAKING AND NO DEVICE ISSUE WITH EITHER THE 3.5X19MM OR THE 4.0X19MM GM STENTS. THERE WAS NO DEVICE MALFUNCTION AND NO COMPLAINT REGARDING THESE TWO DEVICES. POST PROCEDURE IMAGING DISPLAYED OPTIMAL RESULTS. HEMOSTASIS HAD BEEN ACHIEVED WITH NO FURTHER EXTRAVASATION NOTED. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719509 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT DELIVERY SYSTEM MAF ABBOTT VASCULAR 1012581-26 8031641 08717648176418

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention 2.8X19MM GRAFTMASTER STENT