BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1040220 · Received May 7, 2008

    Report

    Report Number
    2182269-2008-00129
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE ANGIO-SEAL INSTRUCTIONS FOR USE (IFU) CAUTIONS SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATES IF PT'S HAVE CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE, BASED ON PUBLISHED MEDICAL LITERATURE, THE ANGIO-SEAL DEVICE CAN BE DEPLOYED SAFELY IN PT ARTERIES > 5 MM DIAMETER WHEN THERE IS FOUND TO BE NO LUMINAL NARROWING OF 40% OR GREATER WITHIN 5 MM OF THE PUNCTURE SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PHYSICIAN THAT FOLLOWING A CARDIAC ANGIOGRAM TO EVALUATE A POSITIVE STRESS TEST, A 6F ANGIO-SEAL VIP WAS USED. A PRE-DEPLOYMENT RIGHT ILIAC DIGITAL ANGIOGRAM WAS PERFORMED. MILD PERIPHERAL VASCULAR DISEASE (PVD) WAS NOTED AT THE INSERTION AREA. DEPLOYMENT OF THE ANGIO-SEAL WAS UNEVENTFUL AND HEMOSTASIS WAS ACHIEVED. NINETEEN DAYS LATER, THE PT EXPERIENCED INTERMITTENT CLAUDICATION EVIDENCE BY LEG PAIN. THE PT WAS EVALUATED WITH DOPPLER AND DUPLEX ULTRASOUNDS AND A PARTIAL OBSTRUCTION WAS IDENTIFIED AT THE PUNCTURE SITE. THE PT WAS CLOSELY MONITORED AND AFTER DISCUSSION WITH THE PHYSICIAN, OPTED TO HAVE SURGERY. TWO DAYS LATER, THE PT UNDERWENT SURGICAL INTERVENTION AND THE ANGIO-SEAL WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VIP MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention BETABLOCKER| TYPES AND DOSES UNK.| STATINS| PLAVIX AND| THE PT WAS TAKING ANTI-COAGULANT MEDICATION| TYPE AND DOSE UNK.| THE PT WAS TAKING MEDICATIONS OF ASPIRIN