BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1790102 · Received August 5, 2010

    Report

    Report Number
    2182269-2010-00145
    Event Type
    Injury
    Date Received
    August 5, 2010
    Date of Event
    July 14, 2010
    Report Date
    August 5, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. TWO RADIOGRAPHIC CT IMAGES WITH THE RADIOGRAPHIC INTERPRETATION AND TWO ULTRASOUND IMAGES WERE RECEIVED WITH THE COMPLAINT. THE TWO COMPUTERIZED IMAGES WERE CONTRAST ENHANCED AND WERE TAKEN IN DIFFERENT PROJECTIONS OF DIFFERENT AREAS WITHIN THE PELVIS AND LOWER EXTREMITY. THERE WERE NO IDENTIFICATION MARKERS PRESENT ON THE IMAGES AND MOST LIKELY REPRESENT IMAGES OBTAINED DURING A CT ANGIOGRAM. THE RADIOGRAPHIC INTERPRETATION SHOULD BE CONSULTED FOR THE OFFICIAL ANALYSIS OF THESE IMAGES. NOTATION ON THE TWO ULTRASOUND IMAGES STATED THAT THE SOURCE OF THE IMAGES WERE FROM AN ARTERY WITH PROBE (B)(4). NO OTHER IDENTIFICATION WAS PRESENT ON THE IMAGES. BASED ON THE INFORMATION PROVIDED TO ST. JUDE MEDICAL, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS TRANSCATHETER ANGIOPLASTY (PTA) BY STENT PLACEMENT IN THE LEFT COMMON ILIAC ARTERY (CIA), A 6F ANGIO-SEAL STS PLUS WAS SELECTED FOR USE. A PRE-DEPLOYMENT ANGIOGRAM REVEALED A LEFT COMMON FEMORAL ARTERY (LCFA) PUNCTURE. NO FURTHER INFORMATION ON THE PUNCTURED ARTERY IS AVAILABLE. THE LCFA PUNCTURE WAS PERFORMED UNDER ULTRASOUND GUIDANCE. WHILE INSERTING THE 6F PROCEDURAL SHEATH INTO THE LCFA, THERE WASN'T ANY RESISTANCE AND THE VESSEL DID NOT HAVE SEVERE CALCIFICATION. THE PTA WAS PERFORMED AND THE ANGIO-SEAL WAS DEPLOYED WITHOUT DIFFICULTY; HOWEVER, THE BLOOD FLOW IN THE AFFECTED LIMB DID NOT IMPROVE AS EXPECTED. THE NEXT DAY, THE PATIENT COMPLAINED OF PAIN AT THE PUNCTURE SITE. THE ANKLE BRACHIAL INDEX (ABI) WAS TAKEN AND THE RESULTS WERE LOWER WHEN COMPARED TO THE PATIENT'S ABI BEFORE ANGIO-SEAL DEPLOYMENT. ONE DAY LATER, A CT SCAN WAS PERFORMED, WHICH SHOWED MILD CALCIFICATION AROUND THE PUNCTURE SITE. CT ANGIOGRAPHY SHOWED THE LCFA TO BE OCCLUDED AT THE AREA BEFORE THE SUPERFICIAL FEMORAL ARTERY AND DEEP FEMORAL ARTERY. A SMALL HEMATOMA WAS ALSO NOTED. AN ULTRASOUND WAS PERFORMED (EXACT DATE UNKNOWN), WHICH REVEALED VESSEL STENOSIS AROUND THE PUNCTURE SITE. ON (B)(6) 2010, THE PATIENT WENT TO SURGERY WERE LEFT FEMORAL ARTERIAL ANGIOPLASTY WAS PERFORMED. THE ANGIO-SEAL WAS REMOVED, THE VESSEL REPAIRED AND BLOOD FLOW RESTORED. THE PHYSICIAN STATED THAT HE DOES NOT BELIEVE THE OCCLUSION WAS CAUSED BY THE DEPLOYMENT TECHNIQUE, BECAUSE THE EXCHANGE FROM THE PROCEDURAL SHEATH TO THE ANGIO-SEAL SHEATH WAS PERFORMED WITH CARE AS TO NOT DISSECT THE VESSEL WALL. THE PATIENT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS ANGIO-SEAL VASCULAR CLOSURE DEVICE MGB ST. JUDE MEDICAL NA 3074081

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R