BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1081585 · Received July 24, 2008

    Report

    Report Number
    2182269-2008-00180
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    January 23, 2008
    Report Date
    July 9, 2008
    Manufacturer
    ST. JUDE MEDICAL
    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 FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFO RECEIVED THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL INSTRUCTION FOR USE (IFU) STATE THAT IF COLLAGEN DEPOSITION INTO THE ARTERY OR THROMBUS AT THE PUNCTURE SITE IS SUSPECTED, THE DIAGNOSIS CAN BE CONFIRMED BY DUPLEX ULTRASOUND. TREATMENT OF THIS MAY INCLUDE THROMBOLYSIS, PERCUTANEOUS THROMBECTOMY, OR SURGICAL INTERVENTION. THE IFU CAUTIONS SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL PT INFO GUIDE STATES WITHIN 60 - 90 DAYS (12 WEEKS), THE ANCHOR, COLLAGEN SPONGE AND SUTURE OF THE ANGIO-SEAL DEVICE WILL NATURALLY BE REABSORBED BY THE BODY.

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION (PCI), AN 8F ANGIO-SEAL STS PLUS WAS SELECTED FOR USE. A PRE-DEPLOYMENT ANGIOGRAM REVEALED MILD CALCIFICATION PROXIMAL TO BUT NOT AROUND THE PUNCTURE SITE. AN 8F MEDIKIT SUPER SHEATH WAS ALSO USED DURING THE PROCEDURE. THE ANGIO-SEAL WAS DEPLOYED AND HEMOSTASIS WAS ACHIEVED. TWO DAYS LATER, THE PT COMPLAINED OF LEG PAIN WHEN WALKING. AN ANKLE BRACHIAL INDEX (ABI) OF 0.52 AND DOPPLER ULTRASOUND CONFIRMED A STENOSIS. AN ANGIOGRAM REVEALED A STENOSIS OF 90%. THE OCCLUSION WAS DETECTED BY INTRAVASCULAR ULTRASOUND (IVUS) AS A "BLACKENED DENSITY", WHICH WAS DIFFERENT FROM PLAQUE DENSITY. A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED AND THE STENOSIS WAS REDUCED TO 50%. THE NEXT DAY FOLLOWING THE PTA AN ABI INCREASED TO 0.74, AND THE PT WAS DISCHARGED. ONE WEEK AFTER DISCHARGE, THE PT WAS FOLLOWED UP. THOUGH A DECREASE IN ABI WAS CONFIRMED, THE PHYSICIAN DECIDED TO KEEP FOLLOWING THE PT AS SHE WAS EXPERIENCING PAIN ONLY WHEN WALKING ALONG DISTANCE. THREE MONTHS AFTER THE PTA, ANOTHER PTA WAS PERFORMED FOR TREATMENT OF THE STENOSIS. THE STENOSIS WAS REDUCED TO 25%. THE NEXT DAY, ABI WAS MEASURED 0.89. A MONTH LATER, THE PT WAS SEEN, BUT THERE WERE NO CONSEQUENCES. THE PT IS STILL BEING FOLLOWED AND IS REPORTEDLY RECOVERING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention