BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 10335133 · Received July 28, 2020

    Report

    Report Number
    2024168-2020-06259
    Event Type
    Injury
    Date Received
    July 28, 2020
    Date of Event
    July 1, 2020
    Report Date
    July 28, 2020
    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
    OK, 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 DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE INVESTIGATION DETERMINED THE REPORTED FAILURE TO ADVANCE AND SUBSEQUENT TREATMENT APPEAR 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON 07/01/2020, THE PATIENT PRESENTED WITH A PERFORATED RAMUS POSTEROLATERALIS SINISTRA (RPLS). A 2.80X16MM GRAFTMASTER STENT DELIVERY SYSTEM (1012580-16, 8120541) ADVANCED, HOWEVER, FAILED TO CROSS THE PERFORATION. THE DEVICE WAS REMOVED AND A 2.0X12MM TREK DILATATION CATHETER WAS USED IN REPLACEMENT, SEALING THE PERFORATION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799516 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT DELIVERY SYSTEM MAF ABBOTT VASCULAR 1012580-16 8120541 08717648176340

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention