BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 1051747 · Received May 23, 2008

    Report

    Report Number
    2953144-2008-00943
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    April 29, 2008
    Report Date
    April 30, 2008
    Manufacturer
    ABBOTT VASCULAR INC.- REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. TIME OF SYMPTOMS/AE: BEFORE AND AFTER VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS, HEMATOMA. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A MILDLY CALCIFIED COMMON FEMORAL ARTERY AFTER A STENTING PROCEDURE. REPORTEDLY, THE PT STARTED DEVELOPING A HEMATOMA AT THE TIME OF VESSEL ACCESS AND DURING THE PROCEDURE. THE PROGLIDE WAS INSERTED AND WHILE COMPLETING THE KNOT ADVANCEMENT AND TIGHTENING UP THE KNOT, THE PHYSICIAN WAS UNSURE IF THE KNOT WAS LOCATED AGAINST THE SUPERIOR ARTERIAL WALL DUE TO THE PT BEING OBESE. AFTER VESSEL CLOSURE COMPLETION, PULSATILE BLEEDING FROM THE FEMORAL ACCESS SITE PERSISTED. ATTEMPTS TO TIGHTEN UP THE KNOT WERE NOT SUCCESSFUL. THE ANTICOAGULANT WAS DISCONTINUED AND MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. AT THAT POINT, THE HEMATOMA WAS REPORTED TO BE GREATER THAN 10CM X 10CM. THE PT EXPERIENCED A VAGAL RESPONSE. THE HEMATOMA WAS ''DRAINED'' LATER THAT DAY. THE PT STARTED HAVING HYPOTENSIVE EPISODES AND REPORTEDLY, FOUR HOURS AFTER THE PROCEDURE, THE PT SUFFERED A MYOCARDIAL INFARCTION DUE TO DOUBLE STENT THROMBOSES, AND PASSED AWAY. THE PHYSICIAN STATED THE PT DEATH WAS DUE TO A COMBINATION OF ESCALATING FACTORS FOLLOWING THE INTERVENTIONAL PROCEDURE. THE PHYSICIAN STATED "THAT HE CHOSE TO USE A CLOSURE DEVICE KNOWING THAT COMPRESSION ON THIS OBESE PT WOULD BE VERY DIFFICULT." THOUGH REQUESTED, NO ADD'L INFO 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 INC.- REDWOOD CITY NA 63038-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention INTEGRILLIN| STENTS: BMS LIBERTE BOSTON SCIENTIFIC