BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1253196 · Received December 5, 2008

    Report

    Report Number
    2953144-2008-01956
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    May 12, 2008
    Report Date
    November 11, 2008
    Manufacturer
    ABBOTT VASCULAR- VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT INVOLVES A CASE NOTED IN AN ARTICLE. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. THE LOT NUMBER WAS NOT IDENTIFIED, THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. BECAUSE THE DEVICE WAS NOT RETURNED, NO ROOT CAUSE CAN BE DETERMINED. PER THE DEVICE INSTRUCTIONS FOR USE, "THE PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE SYSTEM IS DESIGNED FOR USE IN 5F TO 8F ACCESS SITES." ATTACHMENT: W. ANTHONY LEE, MD, ET AL; "MIDTERM OUTCOMES OF FEMORAL ARTERIES AFTER PERCUTANEOUS ENDOVASCULAR AORTIC REPAIR USING THE PRECLOSE TECHNIQUE". JOURNAL OF VASCULAR SURGERY 2008; 47:919-23. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. TIME OF SYMPTOMS/AE: POST PROCEDURE. SYMPTOMS/AE: PSEUDOANEURYSM, INFECTION, THROMBOSIS. THE FOLLOWING EVENT WAS NOTED THROUGH A PERIODIC ARTICLE REVIEW. IT WAS REPORTED THAT 48 DAYS POST ENDOVASCULAR ABDOMINAL AORTIC REPAIR, USING THE PRECLOSE TECHNIQUE WITH A PROGLIDE DEVICE, TO CLOSE AN ARTERIOTOMY WITH AN UNSPECIFIED SHEATH SIZE RANGING FROM 12-24 FR, THE PATIENT PRESENTED WITH A DRAINING SINUS TRACT FROM THE PUNCTURE SITE. THIS WAS EXPLORED AND PACKED. THE WOUND HAD COMPLETELY HEALED, BUT PRESENTED 6 MONTHS LATER WITH A LARGE ABSCESS AND FEMORAL THROMBOSIS. THE PATIENT UNDERWENT A THROMBECTOMY AND FEMORAL REPLACEMENT WITH A BOVINE CAROTID GRAFT. THIS WAS LATER COMPLICATED BY AN ACUTE PSEUDOANEURYSM AND NECROTIZING INFECTION OF THE BOVINE GRAFT 3 WEEKS LATER. THE PATIENT UNDERWENT WIDE DEBRIDEMENT, A REDO FEMORAL REPLACEMENT WITH ANOTHER BOVINE CAROTID GRAFT, AND SARTORIUS FLAP. THE AUTHOR COMMENTED, THAT THE EVENTS WERE NOT RELATED TO THE CLOSURE DEVICE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM MGB ABBOTT VASCULAR- VASCULAR SOLUTIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S