BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 12481718 · Received September 16, 2021

    Report

    Report Number
    2024168-2021-08215
    Event Type
    Injury
    Date Received
    September 16, 2021
    Date of Event
    August 23, 2021
    Report Date
    September 16, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAF
    UDI-DI
    08717648176340
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED STENT DISLODGEMENT; HOWEVER, THE REPORTED TREATMENTS APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT PRESENTED WITH A SAPHENOUS VEIN GRAFT (SVG) TO THE LEFT ANTERIOR DESCENDING (LAD) PERFORATION. A 3.5X26MM AND 3.5X16MM GRAFTMASTER STENT WERE SUCCESSFULLY IMPLANTED, SEALING THE PERFORATION AT THAT SITE. THERE WAS NO DEVICE MALFUNCTION. A 2.80X16MM GRAFTMASTER (1012580-16, 0112541) STENT DELIVERY SYSTEM ALSO ADVANCED. DURING POSITIONING, NO UNUSUAL RESISTANCE WAS NOTED, HOWEVER, THE STENT DISLODGED AT THE LAD OSTIUM. ADDITIONAL DILATATION WAS PERFORMED, DEPLOYING THE 2.80X16MM GRAFTMASTER STENT AT THE OSTIAL LAD. THE PERFORATION HAD SEALED AND THERE WAS NO ADVERSE PATIENT SEQUELA. PER PHYSICIAN, THE GRAFTMASTER DEVICES DID NOT CAUSE OR CONTRIBUTE TO COMPLICATIONS OR ADVERSE EVENTS. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381993 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT DELIVERY SYSTEM MAF ABBOTT VASCULAR 1012580-16 0112541 08717648176340

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention 2 GRAFTMASTER STENTS