BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1050251 · Received May 21, 2008

    Report

    Report Number
    2182269-2008-00143
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 2, 2008
    Report Date
    May 13, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION AND REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFO PROVIDED TO ST JUDE MEDICAL, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL INSTRUCTION FOR USE (IFU) STATES SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT 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 INSTRUCTIONS FOR USE (IFU) STATES THROMBOSIS AT THE PUNCTURE SITE IS A RISK OR SITUATION ASSOCIATED WITH THE USE OF THE ANGIO-SEAL DEVICE OR VASCULAR ACCESS PROCEDURES, IF THROMBUS AT THE PUNCTURE SITE IS SUSPECTED, THE DIAGNOSIS CAN BE CONFIRMED BY DUPLEX ULTRASOUND. TREATMENT OF THIS EVENT MAY INCLUDE THROMBOLYSIS, PERCUTANEOUS THROMBECTOMY, OR SURGICAL INTERVENTION. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) STATES IF PTS 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. THE IFU ALSO INSTRUCTS THE USER TO ASSESS THE PUNCTURE SITE LOCATION AND EVALUATE THE FEMORAL ARTERY CHARACTERISTICS PRIOR TO PLACING THE ANGIO-SEAL DEVICE BY INJECTING CONTRAST MEDIUM THROUGH THE PROCEDURE SHEATH AND USING FLUOROSCOPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A LEFT HEART CATHETERIZATION, A 6F ANGIO-SEAL WAS USED TO CLOSE THE ARTERIOTOMY IN THE RIGHT COMMON FEMORAL ARTERY (CFA). EARLY THE NEXT MORNING, THE PT COMPLAINED OF NUMBNESS IN THE RIGHT LEG AND WAS FOUND TO HAVE A DUSKY, PALE, COOL RIGHT LOWER EXTREMITY WITH NO PULSES. THE PT WAS TAKEN TO SURGERY FOR EXPLORATION AND REPAIR. A SKIN INCISION WAS MADE IN THE RIGHT FEMORAL AREA. THERE WAS AN AREA WHERE THE ANGIO-SEAL WENT IN WITH A SMALL THREAD THAT COULD BE SEEN. THERE WAS A SMALL HEMATOMA. THE PT WAS ALREADY ON A HEPARIN DRIP AND WAS GIVEN AN ADDITIONAL 5000 UNITS OF SYSTEMIC HEPARIN. THE COMMON FEMORAL ARTERY WAS CONTROLLED WITH A VASCULAR CLAMP AND AN ARTERIOTOMY WAS MADE AT THAT LEVEL. THERE WAS THROMBUS ATTACHED TO THE STRING. THE ARTERIOTOMY WAS EXTENDED UP AND DOWN AND THE CLOT ASSOCIATED WITH A PIECE OF THE ANGIO-SEAL ANCHORED ITSELF ON THE POSTERIOR PLAQUE FROM THE COMMON FEMORAL ARTERY. THERE WAS EXTENSIVE CALCIFIED PLAQUE IN THE VESSEL. THIS OCCLUDED THE VESSEL COMPLETELY. AN ENDARTERECTOMY SPATULA WAS USED TO FREE UP AND CLEAN THE AREA. GOOD BACK FLOW WAS ACHIEVED. THE PT TOLERATED THE PROCEDURE WELL AND WAS IN STABLE CONDITION.

    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 86 YR Required Intervention