BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    MDR report key: 1083518 · Received July 29, 2008

    Report

    Report Number
    2953144-2008-01253
    Event Type
    Death
    Date Received
    July 29, 2008
    Date of Event
    August 23, 2001
    Report Date
    July 15, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT INVOLVES A STUDY NOTED IN AN ARTICLE. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. THE PART AND LOT NUMBER WERE NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. ATTACHMENT: RANDOLPH L. GEARY, MD, ET AL; "INFECTION IS AN UNUSUAL BUT SERIOUS COMPLICATION OF A FEMORAL ARTERY CATHETERIZATION SITE CLOSURE DEVICE". ANN VASC SURG 2001; 15:567-570.

    Description of Event or Problem · 1

    SYMPTOMS/AE: INFECTED ACCESS SITE PSEUDOANEURYSM TREATED WITH DEBRIDEMENT AND VEIN PATCH. TIME OF SYMPTOMS/AE: 6 DAYS AFTER VESSEL CLOSURE. THE FOLLOWING EVENT WAS NOTED THROUGH A PERIODIC ARTICLE REVIEW THAT 1807 PATIENTS UNDERWENT DIAGNOSTIC/PERCUTANEOUS CORONARY INTERVENTIONS FOLLOWED BY ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY (CFA) WITH A PROSTAR DEVICE. THE PATIENT UNDERWENT DIAGNOSTIC CARDIAC CATHETERIZATION VIA THE RIGHT FEMORAL ARTERY AND, 4 DAYS LATER, A ROTATIONAL ARTHRECTOMY AND ANGIOPLASTY; AGAIN, USING THE RIGHT FEMORAL ARTERY. VESSEL CLOSURE WAS ACHIEVED WITH AN 8FR PROSTAR DEVICE. SIX DAYS LATER, THE PATIENT DEVELOPED FEVER, CHILLS, AND GROIN PAIN. THE PATIENT WAS EVALUATED THE FOLLOWING DAY DUE TO PROGRESSIVE HEPATIC, RENAL AND PULMONARY DYSFUNCTION. AN INFECTED PSEUDOANEURYSM CAUSED BY S. AUREUS WAS NOTED RESULTING IN DEBRIDEMENT OF THE ABSCESS WITH A SARTORIUS MUSCLE FLAP AND VEIN PATCH. THE PATIENT REMAINED HOSPITALIZED FOR TWENTY-FIVE DAYS AND DESPITE AGGRESSIVE TREATMENT, THE PATIENT'S MULTISYSTEM ORGAN FAILURE PROGRESSED AND EXPIRED 3 WEEKS LATER. THE ARTICLE DOES NOT DESCRIBE THE STERILE TECHNIQUE USED FOR THE VESSEL CLOSURE PROCEDURE AND NO DEVICE MALFUNCTION WAS DESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTAR XL SUTURE-MEDIATED CLOSURE MGB ABBOTT VASCULAR REDWOOD CITY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death SHEATH: 9 FR