BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL DEVICE

    MDR report key: 2041918 · Received March 30, 2011

    Report

    Report Number
    2182269-2011-00052
    Event Type
    Injury
    Date Received
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFO RECEIVED, THE CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) INSTRUCTS THE USER THAT ERRATIC, VIGOROUS TAMPING OR EXCESSIVE UPWARD TENSION ON THE SUTURE MAY RESULT IN COLLAGEN PLACEMENT IN THE ARTERY OR ANCHOR BREAKAGE. THE IFU ALSO INSTRUCTS THE USER TO ASSESS THE PUNCTURE SITE LOCATION AND EVALUATE THE FEMORAL ARTERY CHARACTERISTIC PRIOR TO PLACING THE ANGIO-SEAL DEVICE BY INJECTING CONTRAST MEDIUM THROUGH THE PROCEDURE SHEATH AND USING FLUOROSCOPY. THE IFU CAUTIONS THE USE OF THE ANGIO-SEAL DEVICE IN PTS WITH CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A PRINTED LITERATURE ARTICLE, A STENT IMPLANTATION OF THE LEFT ANTERIOR DESCENDING CORONARY ARTERY WAS PERFORMED AND THE PT WAS PLACED ON 24 HOUR HEPARIN TREATMENT. THE SHEATH WAS REMOVED FROM THE RIGHT FEMORAL ARTERIOTOMY AND AN ANGIO-SEAL WAS DEPLOYED. IN EARLY POST-INTERVENTIONAL PERIOD, THE PT COMPLAINED OF RIGHT THIGH PAIN AND ASSESSMENT OF THE PT REVEALED AN ABSENCE OF DISTAL PEDAL PULSES AND AN OCCLUSION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY AS SEEN ON A DIGITAL ARTERIAL ANGIOGRAM PERFORMED FROM THE LEFT FEMORAL ARTERY. SURGICAL INTERVENTION WAS PERFORMED VIA A VERTICAL INCISION OF THE SUPERFICIAL FEMORAL ARTERY. MATERIAL, ALLEGED INTRA-ARTERIAL COLLAGEN, WAS REMOVED AND A SAPHENOUS VEIN PATCH ANGIOPLASTY WAS PERFORMED. NO COMPLICATIONS WERE OBSERVED POST OPERATIVELY AND THE PT WAS DISCHARGED ON THE FIFTH POST OPERATIVE DAY. THE INCIDENT DATE, IMPLANT DATE, AND EXPLANT DATE ARE UNK AS IS THE ANGIO-SEAL DEPLOYER. ADD'L INFO REVEALED THAT THE PT HAS A MEDICAL HISTORY OF CORONARY ARTERY DISEASE, NO PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED, AND THERE WAS LOCALIZED PLAQUE AT THE OPERATION SITE, AND THE PT WAS REPORTED TO BE IN STABLE CONDITION. SAHIN MA, ET AL, INTRAVASCULAR MISPLACEMENT OF VASCULAR CLOSURE DEVICE CAUSING FEMORAL ARTERY OBSTRUCTION, INT J CARDIOL (2011), DOL:10. 1016/J.IJCARD.2011.02.018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIO-SEAL DEVICE ANGIO-SEAL DEVICE MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R