BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIOJET ULTRA XMI

    MDR report key: 1100423 · Received August 6, 2008

    Report

    Report Number
    2183460-2008-00008
    Event Type
    Other
    Date Received
    August 6, 2008
    Date of Event
    June 28, 2008
    Report Date
    August 6, 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 TRANSFUSION 2 UNITS DUE TO MULTIPLE EXPORT CATHETER ASPIRATION AND ANGIOJET THROMBECTOMY. THIS IS KNOWN COMPLICATION OF INTERVENTIONAL PROCEDURES AND IS APPROPRIATELY DISCLOSED IN THE PRODUCT LABELING. EVENT STATUS REVOLVED WITH NO SEQUELAE. THIS IS AN ADVERSE EVENT DEFINITELY RELATED TO THE PROCEDURE AND POSSIBLY RELATED TO ANGIOJET THROMBECTOMY. REPORTABLE.

    Description of Event or Problem · 1

    (B) (4). PATIENT IS A (B) (6) FEMALE TREATED FOR SUBACUTE LIMB ISCHEMIA. PATIENT HAS A HISTORY OF PRIOR PERIPHERAL INTERVENTIONS, INCLUDING LEFT FEMOROPOPLITEAL BYPASS IN 1994, PTA WITH STENT PLACEMENT X2 TO THE SFA IN 2004, FOR WHICH THE PATIENT RE-THROMBOSED DUE TO NON-COMPLIANCE WITH HER ASA AND PLAVIX REGIMEN AS PRESCRIBED. THE PATIENT SUBSEQUENTLY UNDERWENT ANGIOJET THROMBECTOMY AND CDT FOR RE-THROMBOSIS IN 2004. PATIENT RISK FACTORS INCLUDE PAD, INTERMITTENT CLAUDICATION, HYPERTENSION, NON-INSULIN DEPENDENT DIABETES, HYPERLIPIDEMIA, PRIOR PCI AND CAD. ONSET OF S/S>24 HOURS AND <7 DAYS. ON PRESENTATION, PATIENT HAD COMPLETE OCCLUSION OF RIGHT SFA, RIGHT POPLITEAL ARTERY, COMPLETE OCCLUSION OF THE RIGHT PERONEAL ARTERY, RIGHT TTP TRUNK AND SUBSTANTIAL OCCLUSION OF THE RIGHT ANTERIOR TIBIA. ON (B) (6) 2008, PATIENT UNDERWENT ATHERECTOMY X3, THROMBECTOMY X3, PLACEMENT OF AN EMBOLIC PROTECTION DEVICE (SPYDER EPD), BALLOON ANGIOPLASTY X5, AND STENT PLACEMENT X4. PATIENT HAD DISTAL EMBOLIZATION DUE TO DISTAL POPLITEAL BIFURCATION, DESPITE THROMBECTOMY AND EPD PLACEMENT. THE FILTER WAS FULL AND OVERFLOW LODGED INTO THE DISTAL POPLITEAL BIFURCATION. AN EXPORT CATHETER WAS USED, ALONG W/CATHETER SUCTION THROMBECTOMY TO TRY AND REMOVE THE THROMBUS. THE CLOT WAS STILL EVIDENT ON (B) (6) 2008, SO AN XMI OF THE POPLITEAL, RIGHT TTP TRUNK AND RIGHT ANTERIOR TIBIA WAS UNDERTAKEN. THERE WAS A POST-TREATMENT RESIDUAL CLOT AT THE BIFURCATION, WHICH WAS TREATED WITH THE KISSING BALLOON TECHNIQUE WITH A TAXUS DES TO THE TP TRUNK AND ANTERIOR TIBIA WITH PARTIAL THROMBUS IN THE SMALL PERONEAL. ON (B) (6) 2008, POST-PROCEDURE, THE PATIENT'S HEMATOCRIT DROPPED TO 24 AND WAS TREATED WITH RBCS X2. THE TRANSFUSION WAS INITIATED DUE TO MULTIPLE MANUAL ASPIRATION THROMBECTOMY ATTEMPTS, AS WELL AS MULTIPLE ATTEMPTS WITH THE XMI AND XPEEDIOR. ON FINAL ANGIOGRAPHIC ASSESSMENT, THE RIGHT SUPERFICIAL, RIGHT POPLITEAL ARTERY, RIGHT TP TRUNK AND RIGHT ANTERIOR TIBIA WERE PATENT. THE RIGHT PERONEAL ARTERY WAS OCCLUDED. PATIENT'S STATUS WAS CONSIDERED RESOLVED. THE PHYSICIAN DETERMINED THAT THE EVENT WAS PROBABLY RELATED TO THE ANGIOJET CATHETER, PROBABLY RELATED TO MANUAL ASPIRATION DEVICE (EXPORT), AND DEFINITELY RELATED TO THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention