BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIOJET ULTRA XPEEDIOR

    MDR report key: 1079457 · Received July 18, 2008

    Report

    Report Number
    2183460-2008-00007
    Event Type
    Other
    Date Received
    July 18, 2008
    Date of Event
    June 3, 2008
    Report Date
    July 17, 2008
    Manufacturer
    POSSIS MEDICAL, INC.
    Product Code
    DXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONSISTS OF POST ANGIOJET THROMBECTOMY AND STENT PLACEMENT IN SFA BLEEDING FROM UNK SOURCE REQUIRING TWO UNITS RBC TRANSFUSION WITH NO SEQUELAE. PHYSICIAN THOUGHT EVENT WAS PROBABLY RELATED TO THE ANGIOJET THROMBECTOMY DEVICE AND PROCEDURE. BLEEDING IS A KNOWN RISK OF THROMBECTOMY AND STENTING PROCEDURE AND IS APPROPRIATELY DISCLOSED IN THE DEVICE LABELING. NO DEFICIENCY IN THE DEVICE OR LABELING IS ALLEGED OR SUSPECTED. THIS IS MDR REPORTABLE. NO FURTHER INVESTIGATION WARRANTED.

    Description of Event or Problem · 1

    (B) (4). PT IS AN (B) (6) FEMALE WHO UNDERWENT ANGIOPLASTY AND STENTING OF THE MID AND DISTAL LEFT SFA ON (B) (6) 2008. PT HAS A HISTORY OF HYPERTENSION, INTERMITTENT CLAUDICATION AND HYPERLIPIDEMIA. SHE PRESENTED ON (B) (6) 2008 WITH SUBACUTE LEFT LIMB ISCHEMIA SECONDARY TO THROMBOSIS OF THE PREVIOUSLY PLACED STENTS. ONSET OF S/S < 24 HOURS. THE LEFT SFA WAS COMPLETELY OCCLUDED. THE PT WAS TREATED WITH THROMBECTOMY AND STENT PLACEMENT IN THE SFA. FINAL ANGIOGRAPHIC ASSESSMENT SHOWED A PATENT SFA. ON (B) (6) 2008, THE PT PRESENTED WITH STENT THROMBOSIS SECONDARY TO NON-COMPLIANCE OF HER ANTIPLATELET MEDICATION. ON (B) (6) 2008, THE PT HAD BLEEDING FROM AN UNK SOURCE WHICH REQUIRED AN RBC TRANSFUSION OF TWO UNITS. THIS EVENT WAS THOUGHT TO BE PROBABLY RELATED TO THE ANGIOJET CATHETER AND THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOJET ULTRA XPEEDIOR EMBOLECTOMY CATHETER DXE POSSIS MEDICAL, INC. 105040-001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Life Threatening| R