BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2130197 · Received June 10, 2011

    Report

    Report Number
    2182269-2011-00106
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    April 27, 2011
    Report Date
    June 10, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) CAUTION THAT AN AV FISTULA OR PSEUDOANEURYSM IS A POSSIBLE RISK ASSOCIATED WITH THE USE OF THE ANGIO-SEAL DEVICE OR VASCULAR ACCESS PROCEDURES. IF SUSPECTED, THESE CONDITIONS MAY BE EVALUATED WITH DUPLEX ULTRASOUND. WHEN INDICATED, ULTRASOUND-GUIDED COMPRESSION OF A PSEUDOANEURYSM MAY BE USED AFTER THE ANGIO-SEAL DEVICE HAS BEEN PLACED. 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. A TRAINING RECORD WAS NOT FOUND FOR THE PHYSICIAN. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) CAUTIONS THAT THE ANGIO-SEAL DEVICE IS TO BE USED ONLY BY A LICENSED PHYSICIAN (OR OTHER HEALTH CARE PROFESSIONAL AUTHORIZED BY OR UNDER THE DIRECTION OF SUCH PHYSICIAN) POSSESSING ADEQUATE INSTRUCTION IN THE USE OF THE DEVICE, E.G., PARTICIPATION IN AN ANGIO-SEAL PHYSICIAN INSTRUCTION PROGRAM OR EQUIVALENT. THE ANGIO-SEAL INSTRUCTIONS FOR USE (IFU) STATES THAT BASED ON CLINICAL EXPERIENCE, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT HAD A FOLLOW-UP CEREBRAL ANGIOGRAM AFTER A CRANIOTOMY AND RESECTION OF THE RIGHT TEMPORAL BRAIN DUE TO AN ARTERIOVENOUS MALFORMATION (AVM) ON (B)(6) 2011. A 6F ANGIO-SEAL VIP WAS SELECTED FOR CLOSURE. ALL APPEARED TO BE SUCCESSFUL AND NO COMPLICATIONS WERE NOTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. THE PATIENT WENT TO THE EMERGENCY ROOM ON (B)(6) 2011 COMPLAINING OF SWELLING AND PAIN IN THE RIGHT LOWER EXTREMITY. AN ULTRASOUND AND A COMPUTED TOMOGRAPHY (CT) ANGIOGRAM REVEALED A RIGHT COMMON FEMORAL ARTERY FLOW-LIMITING STENOSIS AND PSEUDOANEURYSM. PATIENT WAS SENT TO SURGERY ON (B)(6) 2011 FOR A PSEUDOANEURYSM REPAIR WITH A GRAFT AND A THROMBECTOMY. PATIENT WAS DISCHARGED ON (B)(6) 2011. ON (B)(6) 2011, THE PATIENT REPORTED PAIN AND SWELLING IN HER RIGHT LOWER EXTREMITY. A COMPUTED TOMOGRAPHY (CT) ANGIOGRAM SHOWED A RIGHT EXTERNAL ILIAC ARTERY OCCLUSION EXTENDING INTO THE RIGHT COMMON FEMORAL ARTERY. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL AND STARTED ON A HEPARIN DRIP AND COUMADIN FOR ANTICOAGULATION. THE PATIENT UNDERWENT COMMON RIGHT ILEOFEMORAL BYPASS SURGERY ON (B)(6) 2011. THE PATIENT HAS REPORTEDLY BEEN DISCHARGED AND IS RECOVERING. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization| R LORTAB| KEPPRA (500 MG B.I.D.)| NAPROSYN (250 B.I.D.)| OXYCODONE| TYLENOL| NORTIPTYLINE (10 Q.H.S.)| XANAX| COUMADIN OR WARFARIN (4 MG)| MULTIVITAMIN| IRON| HEPARIN| PERCOCET (T.I.D.)| COLACE| ZANTAC (150 MG P.O. DAILY)| IBUPROFEN (AS NEEDED)