BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1160479 · Received September 12, 2008

    Report

    Report Number
    3003681312-2008-00090
    Event Type
    Injury
    Date Received
    September 12, 2008
    Date of Event
    July 24, 2008
    Report Date
    September 12, 2008
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO. B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED; THEREFORE, AN EVAL COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO PROVIDED TO ST. JUDE MEDICAL, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL INSTRUCTION FOR USE (IFU) STATES SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL INSTRUCTIONS FOR USE (IFU) STATES THROMBOSIS AT THE PUNCTURE SITE IS A RISK OR SITUATION ASSOCIATED WITH THE USE OF THE ANGIO-SEAL DEVICE OR VASCULAR ACCESS PROCEDURES. IF THROMBUS AT THE PUNCTURE SITE IS SUSPECTED, THE DIAGNOSIS CAN BE CONFIRMED BY DUPLEX ULTRASOUND. TREATMENT OF THIS EVENT MAY INCLUDE THROMBOLYSIS, PERCUTANEOUS THROMBECTOMY, OR SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) FOR A STENOSIS IN THE RIGHT SUPERFICAL FEMORAL ARTERY (SFA), AN ANGIO-SEAL STS PLUS WAS SELECTED FOR USE. A SMART STENT AND A 6F PARENT SHEATH WERE USED. THE STENOSIS WAS REDUCED TO NONE. A PRE-DEPLOYMENT ANGIOGRAM REVEALED NO ANOMALIES AT THE LEFT COMMON FEMORAL ARTERY (CFA). THE DIAMETER OF THE VESSEL WAS APPROX 8MM. A RADIFOCUS GUIDEWIRE WAS USED INSTEAD OF THE PROVIDED GUIDEWIRE. THE ANGIO-SEAL WAS DEPLOYED AND HEMOSTASIS WAS ACHIEVED. THE LEFT ANKLE BRACHIAL INDEX (ABI) WAS MEASURED AT 0.4 BEFORE THE PROCEDURE. EIGHT DAYS LATER, THE PT WAS DISCHARGED. FIFTEEN DAYS POST PROCEDURE, THE PT WAS READMITTED TO THE HOSP WITH LEG PAIN. AN ANGIOGRAM REVEALED A THROMBUS FORMATION AROUND THE ANCHOR IN THE LEFT GROIN CAUSING A ONE CM OCCLUSION. THE THROMBUS WAS ASPIRATED VIA THE RIGHT GROIN. THE VESSEL WAS DILATED THREE TIMES USING A 6MM DIAMETER BALLOON. THE THROMBUS CAUSED THE PERIPHERAL AREA TO BE OCCLUDED. THE PT'S ABI COULD NOT BE FELT. THREE DAYS LATER, THE PT WAS DISCHARGED HOME AND WAS STILL RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS 6F ANGIO-SEAL STS PLUS MGB ST. JUDE MEDICAL PUERTO RICO. B.V. NA 2056252

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention