BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1080480 · Received July 21, 2008

    Report

    Report Number
    2182269-2008-00175
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    May 20, 2008
    Report Date
    June 27, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFORMATION RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) CAUTIONS SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE IFU ALSO STATES FAILURE TO MAINTAIN TENSION ON THE SUTURE WHILE ADVANCING THE COLLAGEN COULD CAUSE THE COLLAGEN TO ENTER THE ARTERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A TWO HOUR CAROTID ARTERY STENTING PROCEDURE (CAS) FOR TREATMENT OF CAROTID STENOSIS, AN 8F ANGIO-SEAL STS PLUS WAS SELECTED FOR USE. A PRE-DEPLOYMENT ANGIOGRAM REVEALED THAT THE RIGHT COMMON FEMORAL ARTERY (CFA) LUMEN WAS OVER 6 MILLIMETERS (MM) WITH NO ANOMALIES. THE ANGIO-SEAL WAS DEPLOYED AND HEMOSTASIS WAS ACHIEVED. THE PATIENT BECAME HYPOTENSIVE AND COMPLAINED FOR LOWER LEG PAIN IN THE ICU. VASOPRESSOR MEDICATION, TYPE AND DOSE UNKNOWN, WAS GIVEN TO MAINTAIN THE PATIENT'S BLOOD PRESSURE. LATER, CARDIAC TAMPONADE, CAUSED BY A TEMPORARY PACEMAKER THAT WAS USED DURING THE CAS, WAS FOUND AND TREATED BY DRAINAGE. THE NEXT DAY, THE PATIENT AMBULATED IN THE MORNING. INTERMITTENT CLAUDICATION SYMPTOMS APPEARED. THE RIGHT SIDE ANKLE BRACHIAL INDEX (ABI) WAS MEASURED 0.5 (DATE UNKNOWN). THE PHYSICIAN SUSPECTED THE CAUSE OF THE PAIN WAS THAT THE BLOOD PRESSURE DROPPED AND BLOOD FLOW WAS SLOWED. ALLEGEDLY, DURING THIS TIME, A THROMBUS FORMED AROUND THE ANCHOR, OR THE COLLAGEN WAS DEPLOYED INSIDE THE ARTERY. A THREE MONTH FOLLOW-UP ON THE PATIENT WAS PLANNED, BUT ANOTHER PHYSICIAN PERFORMED A PERCUTANEOUS CORONARY INTERVENTION (PCI) AND A POST-PROCEDURE ANGIOGRAM DETECTED A SHADOW WHICH WAS NOT THROMBOSIS OR PLAQUE. FOLLOW UP MRA, ULTRASOUND, AND ANGIOGRAM (AOG), DATE UNKNOWN, REVEALED A STENOSIS OF 99%. PERIPHERAL BLOOD FLOW WAS BARELY PRESENT. TREATMENT OPTIONS HAD BEEN DISCUSSED AND SURGICAL REMOVAL OF OCCLUSION IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS 8F ANGIO-SEAL STS PLUS MGB ST. JUDE MEDICAL NA 2049622

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention BUFFERIN 81 MG| PLAVIX 75 MG| PRESTOLE 5 MG