BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    MDR report key: 7051514 · Received November 21, 2017

    Report

    Report Number
    2024168-2017-09143
    Event Type
    Injury
    Date Received
    November 21, 2017
    Date of Event
    November 9, 2017
    Report Date
    November 21, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    H000001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL DEVICES: GUIDE WIRE: RUNTHROUGH NS, GUIDE CATHETER: HYPERION 6F, OTHER: GUIDELINER. 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 THE OPERATIONAL CONTEXT 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 THE PROCEDURE WAS TO TREAT A LESION IN A MODERATELY TORTUOUS AND HEAVILY CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD). A PERFORATION OCCURRED DURING PRE-DILATATION. AN ATTEMPT WAS MADE TO STOP THE BLEEDING WITH A NON-ABBOTT BALLOON, BUT THIS WAS UNSUCCESSFUL. A 2.80X19 RX GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO TREAT THE PERFORATION; HOWEVER, IT FAILED TO CROSS DUE TO THE PATIENT ANATOMY. THE GRAFTMASTER WAS ATTEMPTED TO BE ADVANCED WITH A GUIDELINER; HOWEVER, THE SDS FAILED TO CROSS THE LESION. A PERFUSION BALLOON WAS USED TO TREAT THE PERFORATION WITH LONG INFLATIONS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELA RELATED TO THE GRAFTMASTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829633 GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM CORONARY STENT GRAFT MAF AV-TEMECULA-CT 5120341

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention