BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1273833 · Received December 23, 2008

    Report

    Report Number
    2182269-2008-00379
    Event Type
    Injury
    Date Received
    December 23, 2008
    Report Date
    December 23, 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. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL 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 FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR SEVERELY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING (LAD), AN 8F ANGIO-SEAL STS PLUS WAS SELECTED FOR USE. A PRE-DEPLOYMENT ANGIOGRAM FOUND NO ANOMALIES AT THE RIGHT COMMON FEMORAL ARTERY (CFA) PUNCTURE SITE. A 7F SHEATH WAS USED DURING THE PROCEDURE. THE PATIENT WAS PRE-MEDICATED WITH 200 MG OF ASPIRIN AND 75 MG OF CLOPIDOGREL DAILY, AND RECEIVED A BOLUS OF 7,500 IU HEPARIN. AFTER 8 HOURS OF PCI, THE ANGIO-SEAL STS PLUS WAS DEPLOYED BUT THE PUNCTURE SITE CONTINUED TO BLEED. MANUAL COMPRESSION WAS APPLIED AND HEMOSTASIS WAS ACHIEVED. AT THAT TIME, NO OTHER COMPLICATIONS WERE OBSERVED. THE NEXT DAY, THE PATIENT EXPERIENCED INTERMITTENT CLAUDICATION, AND THE DISTAL ARTERIES WERE NOT PALPABLE. A DOPPLER ULTRASOUND DETECTED A STENOSIS. MAXIMUM SYSTOLIC BLOOD FLOW VELOCITY (MSV) WAS 361CM PER SECOND, AND AN ARTERIAL BRACHIAL INDEX (ABI) WAS MEASURED AT ZERO. 12 DAYS AFTER THE PCI, A LOWER EXTREMITY ARTERIOGRAM REVEALED A 99% STENOSIS IN THE RIGHT CFA. A PERCUTANEOUS PERIPHERAL INTERVENTION (PPI) WAS PERFORMED WHERE A 2.5X40 MM IKAZUCHI BALLOON (KANEKA) WAS DILATED. INTRAVASCULAR ULTRASOUND (IVUS) FOUND A HIGH ECHO CENTRIC LESION AND IT WAS SUSPECTED TO BE THE ANGIO-SEAL ANCHOR AND COLLAGEN. A FURTHER INFLATION USING A 6.0X40 SUBMARINE PLUS (SJM/INVATEC) WAS PERFORMED. THERE WAS 50% RESIDUAL STENOSIS BUT NORMAL FLOW TO THE LOWER LIMB WAS OBSERVED. AFTER THE PPI, THE PATIENT BECAME FREE OF INTERMITTENT CLAUDICATION, AND THE ABI IMPROVED TO 0.65. TWO MONTHS LATER, A RIGHT FEMORAL ANGIOGRAM REVEALED THAT THE BLOOD FLOW WAS IMPROVED AND AN ABI WAS ALSO IMPROVED TO 0.81. THE PATIENT WAS TAKING PRESCRIBED ANTI-COAGULANT MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS 8F ANGIO-SEAL STS PLUS MGB ST. JUDE MEDICAL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention