BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1020649 · Received March 27, 2008

    Report

    Report Number
    2182269-2008-00112
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    February 22, 2008
    Report Date
    March 25, 2008
    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. THE ANGIO-SEAL WAS FROM ONE OF 3 LOTS, 2042430, 2029573, AND 2023364. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. LOT 2042430 MFG DATE; 10/2007 EXP DATE; 10/1/2008. LOT 2029573 MFG DATE; 8/2007 EXP DATE; 8/1/2007. LOT 2023364 MFG DATE; 6/2007 EXP DATE; 6/1/2008. BASED ON THE INFORMATION RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) CAUTIONS THE USE OF THE ANGIO-SEAL DEVICE IF THERE IS SUSPICION THAT THE INTRODUCER HAS BEEN PLACED INTO THE SUPERFICIAL FEMORAL ARTERY. COLLAGEN DEPOSITION INTO THE SUPERFICIAL FEMORAL ARTERY COULD RESULT, WHICH MAY REDUCE THE BLOOD FLOW THROUGH THE VESSEL. THE IFU CAUTIONS THE USE OF THE ANGIO-SEAL DEVICE IN PATIENTS WITH CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE. THE 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 CORONARY INTERVENTION (PCI), AN ANGIO-SEAL STS PLUS WAS SELECTED FOR USE. A PRE-DEPLOYMENT FEMORAL ANGIOGRAM REVEALED THAT THE SUPERFICIAL FEMORAL ARTERY (SFA) WAS PUNCTURED AND STENOSIS WAS PRESENT AT THE PUNCTURE SITE. SEVERE CALCIFICATION WAS SEEN IN THE ARTERY. A 6F MEDIKIT, 17 CENTIMETERS (CM) PROCEDURE SHEATH WAS USED FOR THE EXAM. THE 6F ANGIO-SEAL STS PLUS DEVICE WAS DEPLOYED AND HEMOSTASIS WAS ACHIEVED. TWO HOURS LATER, THE PATIENT EXPERIENCED NUMBNESS IN THE LEG DURING THEIR BED REST. A DOPPLER ULTRASOUND AND CT REVEALED A VESSEL OCCLUSION AT THE PUNCTURE SITE. THE PATIENT UNDERWENT SURGICAL INTERVENTION TO RESTORE BLOOD FLOW TO THE VESSEL. THE ANGIO-SEAL WAS REMOVED. THE PATIENT IS REPORTED TO BE RECOVERING AND WAS DISCHARGED FROM THE HOSPITAL. THE ANGIO-SEAL WAS FROM ONE OF 3 LOTS, 20242430, 2029573, AND 2023364.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR BAYASPIRIN| PLAVIX| WARFARIN