BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1063398 · Received June 19, 2008

    Report

    Report Number
    2024168-2008-00509
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 23, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING DETERMINED THAT THE DEVICE WAS IN WORKING ORDER AND LEFT ABBOTT VASCULAR INSTRUMENTS AS PER SPECIFICATIONS. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION; THEREFORE, NO COMPLAINT ROUTE CAUSE CAN BE IDENTIFIED. IT IS REPORTED THAT THE COMPLICATIONS THAT OCCURRED WERE NOT RELATED TO THE STENT GRAFT AND THAT THE PATIENT DID NOT EXPERIENCE ADVERSE EVENTS. IT IS REPORTED THAT THE EASE OF HANDLING OF THE STENT GRAFT DEVICE WAS EXCELLENT. NO DEVICE MALFUNCTION CAN BE DETERMINED DUE TO THE LACK OF PROCEDURE AND PATIENT INFORMATION AND THE LACK OF DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/REQUIRED INTERVENTION/HOSPITALIZATION. REPORTING RATIONALE: DIFFICULT TO POSITION RESULTING IN HOSPITALIZATION AND SURGICAL INTERVENTION. DEVICE ISSUE: DIFFICULT TO POSITION. IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO PLACE THE GRAFTMASTER; HOWEVER, IT WAS UNABLE TO FEED WITH A 6FR GUIDE CATHETER. PATIENT WAS SENT TO SURGERY. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 504416

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R GUIDE CATHETER: 6FR