BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 969362 · Received December 19, 2007

    Report

    Report Number
    2953144-2007-01255
    Event Type
    Injury
    Date Received
    December 19, 2007
    Report Date
    November 25, 2007
    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
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ABBOTT VASCULAR; THEREFORE, WE WERE NOT ABLE TO PERFORM A DEVICE ANALYSIS. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. LITERATURE SEARCH ARTICLE: NEW ENGLAND SOCIETY FOR VASCULAR SURGERY 2007; 45: 1095-1101. WRITTEN BY W. ANTHONY LEE, MD, TITLED "TOTAL PERCUTANEOUS ACCESS FOR ENDOVASCULAR AORTIC ANEURYSM REPAIR ("PRECLOSE" TECHNIQUE)".

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: UNK. TIME OF SYMPTOMS/AE: DURING VESSEL CLOSURE. SYMPTOMS/AE: RETROPERITONEAL HEMORRHAGE TREATED WITH STENT. THIS WAS NOTED THROUGH A PERIODIC ARTICLE REVIEW THAT ASSESSED TOTAL PERCUTANEOUS ACCESS FOR ENDOVASCULAR AORTIC ANEURYSM REPAIR. A PRECLOSE TECHNIQUE WAS USED INVOLVING DEPLOYMENT OF THE PROGLIDE DEVICE BEFORE PROCEDURE SHEATH INSERTION. A TOTAL OF 559 PROGLIDE DEVICES WERE USED TO CLOSE 279 FEMORAL ARTERIES; THERE WERE FAILURES, MAINLY DUE TO OBESITY, DEVICE MALFUNCTION, SEVERE CALCIFICATION AND FAULTY ARTERIAL PUNCTURES. DURING THE VESSEL CLOSURE PROCEDURE OF THE COMMON FEMORAL ARTERY WITH THE PROGLIDE, SEVERE RETROPERITONEAL HEMORRHAGE WAS NOTED REQUIRING USE OF A STENT FOR REPAIR. INFORMATION REGARDING THE CAUSE FOR THE RETROPERITONEAL HEMORRHAGE WAS NOT SPECIFIED. REPORTEDLY, THE SUPRAINGUINAL PUNCTURE WAS HIGH. NO ADDITIONAL EVENT OF PATIENT INFORMATION IS AVAILABLE.

    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 UNK YR Required Intervention SHEATH: 24F