BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 1412741 · Received July 8, 2009

    Report

    Report Number
    2182269-2009-00180
    Event Type
    Injury
    Date Received
    July 8, 2009
    Date of Event
    November 19, 2008
    Report Date
    July 8, 2009
    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; THEREFORE, AN EVAL COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORDS FOR THREE POSSIBLE LOTS, 2086897, 2153701 AND 2658376 WERE REVIEWED AND THAT CONFIRMED THESE THREE LOTS MET MFG REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO PROVIDED TO ST JUDE MEDICAL, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH A LITERATURE ARTICLE (JOURNAL OF CARDIOVASCULAR INTERVENTION AND THERAPEUTICS) THAT THE PT WAS ADMITTED TO THE HOSP FOR UNSTABLE ANGINA. A CORONARY ANGIOGRAPHY REVEALED TRIPLE VESSEL DISEASE. FOLLOWING AN URGENT PERCUTANEOUS CORONARY INTERVENTION (PCI) IN THE RIGHT CORONARY ARTERY, MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. EIGHT DAYS LATER, A PCI WAS PERFORMED IN THE LEFT ANTERIOR DESCENDING ARTERY AND LEFT CIRCUMFLEX ARTERY VIA THE RIGHT FEMORAL ARTERY. AFTER A FEMORAL ANGIOGRAPHY, AN 8F ANGIO-SEAL WAS DEPLOYED. HOWEVER, THE PT EXPERIENCED BRISK ARTERIAL BLEEDING AND MANUAL COMPRESSION WAS APPLIED. WHEN THE PT AMBULATED FOLLOWING BED REST, BLEEDING OCCURRED AND MANUAL COMPRESSION WAS APPLIED. THE PT'S HEMOGLOBIN DROPPED 4 G/DL FROM THE BASE LINE, AND A HEMATOMA THAT WAS LESS THAN 5 CM DEVELOPED. DURING THE NIGHT, THE PT FELT PAIN IN THE RIGHT FOOT, AND PULSES WERE NOTED TO BE DIMINISHED IN THE RIGHT DORSALIS PEDIS ARTERY. A COMPUTED TOMOGRAPHY WITH CONTRAST MEDIA REVEALED AN OCCLUSION IN THE RIGHT POPLITEAL ARTERY. THE PT UNDERWENT THROMBECTOMY WITH A FOGARTY CATHETER, WHICH RESTORED DISTAL PERFUSION. THE PHYSICIAN ALLEGED THAT THE CAUSE OF THE ARTERIAL OCCLUSION WAS CONSIDERED TO BE MIGRATION OF THE COLLAGEN MATERIAL OF THE ANGIO-SEAL. THE SPECIMEN COLLECTED BY THE FOGARTY CATHETER DID NOT CONTAIN APPARENT SUBSTANCE LIKE COLLAGEN, OR ANCHOR BUT THROMBI. THE PHYSICIAN ALLEGED THROMBI ATTACHED ITSELF TO THE ANCHOR AND THEN MIGRATED THROUGH THE ARTERY, OR WHEN THE HEMATOMA DEVELOPED, THE MANUAL COMPRESSION FORMED THE THROMBI AND THAT THROMBI MIGRATED TO OCCLUDE THE VESSEL. NO ADDITIONAL INFO IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention MEDICATION.| THE PT WAS TAKING PRESCRIBED ANTI-COAGULANT