BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1000020 · Received May 14, 2007

    Report

    Report Number
    3003681312-2007-00026
    Event Type
    Injury
    Date Received
    May 14, 2007
    Date of Event
    April 17, 2007
    Report Date
    April 23, 2007
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, B.V.
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATE THAT BLEEDING OR HEMATOMA AT THE PUNCTURE SITE IS A POSSIBLE RISK OR SITUATION THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE OR VASCULAR ACCESS PROCEDURES. IF THIS SHOULD OCCUR, THE IFU INSTRUCT THE USER TO APPLY DIGITAL OR MANUAL PRESSURE TO THE PUNCTURE SITE. IF NECESSARY, MONITOR PEDAL PULSES. THE ANGIO-SEAL IFU STATES THAT IF COLLAGEN DEPOSTION INTO THE ARTERY IS SUSPECTED, THE DIAGNOSIS CAN BE CONFIRMED BY DUPLEX ULTRASOUND. TREATMENT OF THIS MAY INCLUDE THROMBOLYSIS, PERCUTANEOUS THROMBECTOMY, OR SURGICAL INTERVENTION. THE ANGIO-SEAL IFU INSTRUCTS THE USER ONCE A FULL REAR LOCK POSITION HAS BEEN ACHIEVED, AND THE DEVICE IS BEING DEPLOYED, TO NOT RE-INSERT THE DEVICE. RE-INSERTION OF THE DEVICE AFTER PARTIAL DEPLOYMENT COULD CAUSE COLLAGEN TO BE DEPOSITED IN THE ARTERY. THE IFU ALSO STATE FAILURE TO MAINTAIN TENSION ON THE SUTURE WHILE ADVANCING THE COLLAGEN COULD CAUSE THE COLLAGEN TO ENTER THE ARTERY. THE ANGIO-SEAL IFU PRECAUTIONS THE USE OF THE ANGIO-SEAL DEVICE IN PTS WITH CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION (PCI) A 6F ANGIO-SEAL VIP WAS DEPLOYED IN THE RIGHT FEMORAL ARTERY. A PRE-DEPLOYMENT FEMORAL ANGIOGRAM REVEALED SIGNIFICANT ATHEROSCLEROTIC DISEASE, BUT AN INABILITY TO COMPRESS THE ACCESS SITE ON A PRIOR PROCEDURE PROMPTED THE ANGIO-SEAL USE. HEMOSTASIS WAS NOT ACHIEVED AND MANUAL COMPRESSION WAS APPLIED. THE PT WAS TRASNFERRED TO ANOTHER HOSP FOR RECOVERY WHERE THE PT EXPERIENCED PAIN IN THE RIGHT FOOT AND EVAL REVEALED NO DOPPLERABLE PULSE IN THE RIGHT LOWER LEG. AN ARTERIAL DUPLEX SCAN REVEALED MODERATE TO SEVERE CALCIFIED PLAQUE THROUGHOUT THE LEG WITH AN INCREASED VELOCITY THAT SUGGESTED A SIGNIFICANT STENOSIS AT THE SUPERFICIAL FEMORAL ARTERY (SFA). A CT SURGICAL EXPLORATION REVEALED THE COLLAGEN PLUG FROM THE ANGIO-SEAL WAS INTRAVASCULAR AND WAS OCCLUDING THE VESSEL. THE ANGIO-SEAL WAS REMOVED AND A VEIN PATCH RESTORED FLOW TO THE LOWER EXTREMITY. THE PT WAS FEELING MUCH IMPROVED WITH SLIGHT NUMBNESS IN THE FOOT.

    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, PUERTO RICO, B.V. NA 1877

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention DIOVAN HCTZ, 320/25 P.O.| PLAVIX, 75 MG P.O| COMBIVENT INHALER 2 PUFFS 4 TIMES A DAY| ZOCAR, 20 NIGHTLY| LOPRESSOR, 25 B.I.D.| NORVASC, 10 DAILY| ASPIRIN, 81 DAILY