BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER

    MDR report key: 9934012 · Received April 8, 2020

    Report

    Report Number
    2024168-2020-03451
    Event Type
    Injury
    Date Received
    April 8, 2020
    Date of Event
    March 17, 2020
    Report Date
    April 29, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MAF
    UDI-DI
    08717648176364
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL AND DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED FAILURE TO ADVANCE COULD NOT BE TESTED AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. 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 DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE INVESTIGATION DETERMINED THE REPORTED FAILURE TO ADVANCE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE. B5: THE GRAFTMASTER SIZE IS 2.80 NOT 2.50. NO CHANGE TO D4.

    Description of Event or Problem · 0

    CORRECTION: THE GRAFTMASTER SIZE IS 2.80, NOT 2.50.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A PRE-EXISTING PERFORATION IN THE MID-LEFT ANTERIOR DESCENDING ARTERY. THE 2.50X26MM GRAFTMASTER STENT DELIVERY SYSTEM FAILED TO CROSS A NON-ABBOTT STENT. THE PERFORATION WAS SEALED WITH BYPASS SURGERY. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403410 GRAFTMASTER CORONARY STENT DELIVERY SYSTEM MAF ABBOTT VASCULAR 1012580-26 8103141 08717648176364

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention GUIDEZILLA| SYNERGY