BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1910509 · Received November 19, 2010

    Report

    Report Number
    3003681312-2010-00074
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 19, 2010
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO PROVIDED TO ST. JUDE MEDICAL, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) RECOMMENDS THAT A PRE-PLACEMENT ARTERIAL ANGIOGRAM BE PERFORMED TO ENSURE CORRECT PLACEMENT OF THE DEVICE IN THE COMMON FEMORAL ARTERY (CFA). THE ANGIO-SEAL INSTRUCTIONS FOR USE (IFU) STATE THAT IF COLLAGEN DEPOSITION INTO THE ARTERY OR THROMBOSIS 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 ANGIO-SEAL DEVICE INSTRUCTION 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) CAUTION USING OF THE ANGIO-SEAL DEVICE IF THERE IS SUSPICION THAT THE INTRODUCER HAS BEEN PLACED THROUGH THE SUPERFICIAL FEMORAL ARTERY AND INTO THE PROFUNDA FEMORIS. COLLAGEN DEPOSITION INTO THE SUPERFICIAL FEMORAL ARTERY COULD RESULT, WHICH MAY REDUCE THE BLOOD FLOW THROUGH THE VESSEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANGIO-SEAL WAS DEPLOYED POST LEFT HEART CATHETERIZATION. REPORTEDLY, A PRE-DEPLOYMENT ANGIOGRAM WAS NOT PERFORMED. AN ULTRASOUND REVEALED AN OCCLUSION OF THE SUPERFICIAL FEMORAL ARTERY (SFA). AN ANGIOGRAM OF THE RIGHT LEG WAS PERFORMED (B)(6) 2010 SHOWED THROMBUS IN THE MID SFA. A MICROMEWIE INFUSION CATHETER WAS PLACED IN THE PT TO DELIVER TPA OVERNIGHT. THE PT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) WITH PEDAL PULSES OF 2 (LEFT) AND 1 AND THREADY (RIGHT). HEPARIN 3000 UNITS WAS GIVEN DURING THE PROCEDURE. THE NEXT DAY THE PT RETURNED TO THE CATH LAB WHERE IMAGING WITH CONTRAST SHOWED THAT THE CLOT DISSOLVED, BUT THE ANGIO-SEAL ANCHOR WAS VISIBLE. A FOX HOLLOW FILTERWIRE WAS UTILIZED AND WAS ABLE TO BREAK UP THE ANCHOR AND REMOVE SOME OF IT. THE PT RETURNED TO THE ICU FOR CLOSE MONITORING OF CIRCULATION IN THE RIGHT LEG AND HAS REMAINED STABLE WITH CIRCULATION MAINTAINED. PRIOR TO THE PROCEDURE THE PT WAS GIVEN NORCO 5-325 MG, Q 6 PRN AND OMEPRAZOLE 20 MG, 1 DAILY. DURING AND POST PROCEDURE, THE PT RECEIVED HEPARIN AND TPA AND IS NOW ON ASPIRIN AND PLAVIX (DOSE UNK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP ANGIO-SEAL VASCULAR CLOSURE DEVICE MGB ST. JUDE MEDICAL PUERTO RICO NA 3115347

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R