BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 1980319 · Received February 2, 2011

    Report

    Report Number
    3003681312-2011-00007
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    December 6, 2010
    Report Date
    February 2, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO REC'D, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) PRECAUTION THAT IF THE PUNCTURE SITE IS AT OR DISTAL TO THE BIFURCATION OF THE SUPERFICIAL FEMORAL AND PROFUNDA FEMORIS ARTERY, AS THIS MAY RESULT IN THE ANGIO-SEAL DEVICE ANCHOR CATCHING ON THE BIFURCATION OR BEING POSITIONED INCORRECTLY, AND/OR COLLAGEN DEPOSITION IN THE VESSEL. THESE EVENTS MAY REDUCE BLOOD FLOW THROUGH THE VESSEL LEADING TO SYMPTOMS OF DISTAL ARTERIAL INSUFFICIENCY. THE ANGIO-SEAL INSTRUCTIONS FOR USE (IFU) STATES SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, A 6F ANGIO-SEAL VIP WAS DEPLOYED POST CARDIAC CATHETERIZATION IN RIGHT FEMORAL ARTERIOTOMY. THERE WERE NO POST OPERATIVE COMPLICATIONS AND THE PT WAS DISCHARGED LATER THAT DAY. ON (B)(6) 2010, THE PT EXPERIENCED RIGHT LEG PAIN AND A COLD FOOT W/O PALPABLE PULSES DISTALLY; THE PT WAS READMITTED TO THE HOSPITAL. A CT SCAN, ULTRASOUND, AND ANGIOGRAPHY WERE PERFORMED TO DIAGNOSE THE VASCULAR INSUFFICIENCY WITH INTRALUMINAL MATERIAL PRESENT. ON (B)(6) 2010, THE PT UNDERWENT A SURGICAL EXPLORATION OF THE COMMON FEMORAL ARTERY (CFA), ENDARTERECTOMY, AND EMBOLECTOMY ON THE RIGHT LEG WITH GOOD RESULTS AND THE PT WAS DISCHARGED. ON (B)(6) 2010, THE PT WAS READMITTED TO THE HOSPITAL WITH RECURRENCE OF ISCHEMIA IN HER RIGHT FOOT. ON (B)(6) 2010, THE PT UNDERWENT A FEM-FEM CROSS OVER GRAFT BUT EXPERIENCED ANOTHER RECURRENCE OF RIGHT FOOT ISCHEMIA IN HER RIGHT FOOT AND SHE WAS TAKEN BACK TO SURGERY FOR A RIGHT POPLITEAL EMBOLECTOMY. ALLEGEDLY SURGICAL FINDINGS REVEALED INTRALUMINAL THROMBUS CAUSED A COMPLETE OCCLUSION TO THE RIGHT FEMORAL ARTERY (RFA) ABOVE THE INGUINAL LIGAMENT. THE PT'S CONDITION WAS REPORTED TO BE STABLE AND THE HOSPITALIZATION WAS EXTENDED DUE TO THE EVENT. NO ADD'L INFO WAS AVAILABLE.

    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 3107982

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R