BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL EVOLUTION

    MDR report key: 2080528 · Received April 22, 2011

    Report

    Report Number
    2182269-2011-00065
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 23, 2011
    Report Date
    April 21, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    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 RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. 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. 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. NO ANGIO-SEAL EVOLUTION TRAINING RECORD WAS AVAILABLE. THE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING A BILATERAL COMMON ILIAC ARTERY ANGIOPLASTY AND STENT PLACEMENT, AN ANGIO-SEAL EVOLUTION WAS DEPLOYED IN THE LEFT FEMORAL AND RIGHT FEMORAL PUNCTURE SITES: DURING THE PROCEDURE, 6F PROCEDURE SHEATH WERE USED AND 5,000 UNITS OF HEPARIN WAS GIVEN. THE PT WAS DISCHARGED LATER THAT DAY WITHOUT INCIDENT. THE PT DEVELOPED NUMBNESS AND COOLNESS IN BOTH FEET AND PALLOR WAS PRESENT, SUBSEQUENTLY, SHE WAS ADMITTED TO THE HOSPITAL TWO DAYS LATER, ON (B)(6) 2011. LEFT LOWER EXTREMITY PULSES WERE ABSENT AND A CT ANGIOGRAM PERFORMED ON (B)(6) 2011 REVEALED NONCALCIFIED INTRALUMINAL ECCENTRIC PLAQUE IN THE PROXIMAL LEFT COMMON FEMORAL ARTERY AND A SOFT TISSUE STRANDING WHICH CAUSED A FOCAL NEAR COMPLETE OCCLUSION. MULTIPLE INDWELLING STENTS WERE SEEN EXTENDING FROM THE DISTAL ABDOMINAL AORTA TO THE DISTAL EXTERNAL ILIAC ARTERY ON THE RIGHT SIDE AND TO THE MID EXTERNAL ILIAC ARTERY ON THE LEFT SIDE. THE PT UNDERWENT SURGICAL LEFT COMMON FEMORAL ARTERY EXPLORATION, REMOVAL OF THE ANGIO-SEAL, AND LEFT COMMON FEMORAL ENDARTERECTOMY WITH PATCH ANGIOPLASTY. THE PT TOLERATED THE PROCEDURE, WAS REPORTED TO BE STABLE AND DISCHARGED ON (B)(6) 2011. THE PT HAS A MEDICAL HISTORY OF HYPERTENSION, HYPERLIPIDEMIA, HISTORY OF SMOKING, PERIPHERAL VASCULAR DISEASE WITH MULTIPLE STENTS, INTERMITTENT CLAUDICATION AND WAS ON MEDICATIONS OF ASPIRIN, 81 MG QD, CRESTOR, CLONIDINE, OMEPRAZOLE, AND BYSYSTOLIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL EVOLUTION ANGIO-SEAL EVOLUTION MGB ST. JUDE MEDICAL NA 3262504

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R OMEPRAZOLE| CRESTOR| BYSYSTOLIC| ASPIRIN, 81 MG QD| CLONIDINE