BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1020652 · Received March 27, 2008

    Report

    Report Number
    3003681312-2008-00036
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 19, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RECEIVED 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) STATES 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 IFU CAUTIONS SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE IFU STATES IF PATIENT'S HAVE CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE, BASED ON PUBLISHED MEDICAL LITERATURE, THE ANGIO-SEAL DEVICE CAN BE DEPLOYED SAFELY IN PATIENT 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 FOLLOWING A CARDIAC CATHETERIZATION PERFORMED THE DAY PRIOR FROM A RIGHT FEMORAL ARTERY (RFA) PUNCTURE MANUAL COMPRESSION WAS USED TO OBTAIN HEMOSTASIS, LEAVING THE RIGHT GROIN PUNCTURE SITE WAS VERY BRUISED. THIS ANGIOGRAM REVEALED LEFT RENAL ARTERY STENOSIS IN A 2 YEAR OLD STENT. THE NEXT DAY, THE PHYSICIAN RE-ACCESSED THE RFA FOR AN INTERVENTIONAL STUDY OF THE RENAL ARTERY. THE ANGIOGRAM REVEALED THAT INTERVENTION WAS NOT NECESSARY. A PRE-DEPLOYMENT DIGITAL SUBTRACTION ANGIOGRAM WAS PERFORMED AND THE RFA MET CRITERIA. THE PATIENT HAS HISTORY OF BILATERAL ILIAC STENT PLACEMENT WHICH WERE NOT VISIBLE ON THE DIGITIZED IMAGES. A 6F ANGIO-SEAL WAS USED TO SEAL THE ARTERIOTOMY IN SPITE OF THE BRUISING AT THE PUNCTURE SITE. HEMOSTASIS WAS NOT OBTAINED AND THE PHYSICIAN HELD MANUAL COMPRESSION FOR 15 MINUTES ACHIEVING HEMOSTASIS. THE PATIENT LOST PEDAL PULSES IN THE RIGHT LEG AND A VASCULAR SURGEON WAS CONSULTED. THE PATIENT UNDERWENT SURGICAL INTERVENTION. REPORTEDLY, THE SURGEON FOUND THE ANGIO-SEAL COLLAGEN SPONGE NEATLY PACKED ON THE OUTSIDE OF THE ARTERY. THE LOCATION OF THE ANCHOR WAS NOT SEEN. THE RFA HAD A DISSECTION PRESENT WITHIN THE EXTERNAL ILIAC STENT AND WAS OCCLUDED. A GRAFT WAS PLACED TO REPAIR THE VESSEL. THE SURGEON STATED THAT THE ARTERY WAS VERY FRAGILE AND THAT THE OCCLUSION WOULD LIKELY HAVE HAPPENED WHETHER THE ANGIO-SEAL HAD BEEN PLACED OR NOT.

    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 2051842

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention