BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 11131956 · Received January 7, 2021

    Report

    Report Number
    2024168-2021-00199
    Event Type
    Injury
    Date Received
    January 7, 2021
    Date of Event
    December 14, 2020
    Report Date
    January 7, 2021
    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
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A PSEUDOANEURYSM. IT SHOULD BE NOTED THAT THE GRAFTMASTER RAPID EXCHANGE (RX), CORONARY STENT GRAFT SYSTEM, DOMESTIC INSTRUCTIONS FOR USE, 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. THE INVESTIGATION DETERMINED THE REPORTED FAILURE TO ADVANCE, MATERIAL DEFORMATION AND THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED WITH ACUTE CORONARY SYNDROME AND WITH A MID-LEFT ANTERIOR DESCENDING (LAD) PSEUDOANEURYSM, STATUS POST A RECENT PERCUTANEOUS CORONARY INTERVENTION (PCI) ON THE LAD AND DIAGONAL PERFORMED ON (B)(6) 2020. THE PSEUDOANEURYSM WAS AT THE SAME SITE THE NON-ABBOTT ROTABLATOR HAD BECOME STUCK DURING THE PREVIOUS PCI. SEVERAL ADDITIONAL CORONARY LESIONS AND STENOSED CORONARY GRAFTS WERE OBSERVED AND ANOTHER PCI WAS PERFORMED ON (B)(6) 2020. A 3.5X26MM GRAFTMASTER (GM) STENT DELIVERY SYSTEM WAS UNABLE TO ADVANCE TO THE MID LAD PSEUDOANEURYSM SITE DUE TO ANATOMY. THE DEVICE WAS REMOVED WITHOUT ISSUE AND RAISED STENT STRUTS WERE OBSERVED. THE DEVICE WAS DISCARDED. IN REPLACEMENT, A GUIDELINER WAS PLACED AND A 3.5X16MM GRAFTMASTER STENT (1012581-16, 9032941) WAS DEPLOYED AT NOMINAL PRESSURES WITHOUT A DEVICE ISSUE. A TINY LEAK WAS SEEN FROM THE PSEUDOANEURYSM SITE. POST-DILATATION AND BALLOON DILATATION WAS PERFORMED ON THE PSEUDOANEURYSM, SEALING THE PSEUDOANEURYSM. REPORTEDLY, THE PSEUDOANEURYSM WAS LARGER THAN THE 3.5X26MM GRAFTMASTER STENT AND THERE WAS NO STENT LEAKING. BALLOON DILATATION HAD SEALED THE ENTIRE PSEUDOANEURYSM. THERE WAS NO DEVICE MALFUNCTION, NO DIFFICULTY WITH DEPLOYMENT, NO STENT LEAKING, OR COMPLAINT REGARDING THE 3.5X16MM GM DEVICE. PER PHYSICIAN, THE GM DEVICES DID NOT CAUSE OR CONTRIBUTE TO COMPLICATIONS NOR ADVERSE EVENTS. ADDITIONAL CORONARY VESSELS AND CORONARY GRAFTS WERE TREATED WITHOUT FURTHER ISSUES REPORTED. REPORTEDLY, THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30395 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT DELIVERY SYSTEM MAF ABBOTT VASCULAR 1012581-26 9093041 08717648176418

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention