BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS

    MDR report key: 2010816 · Received March 2, 2011

    Report

    Report Number
    2182269-2011-00035
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    January 25, 2011
    Report Date
    March 2, 2011
    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 CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO PROVIDED TO ST JUDE MEDICAL, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVE DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT IF THE ANGIO-SEAL DEVICE DOES NOT ANCHOR IN THE ARTERY DUE TO IMPROPER ORIENTATION OF THE ANCHOR OR PT VASCULAR ANATOMY, ABSORBABLE COMPONENTS AND DELIVERY SYSTEM SHOULD BE WITHDRAWN FROM THE PT. HEMOSTASIS CAN THEN BE ACHIEVED BY APPLYING MANUAL PRESSURE. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) CAUTIONS, SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. ACCORDING TO THE IFU, THE SAFETY AND EFFECTIVENESS OF THE ANGIO-SEAL HAS NOT BEEN ESTABLISHED IN PATIENTS WITH CLINICALLY SIGNIFICANT PERIPHERAL VASCULAR DISEASE. THE ANGIO-SEAL INSTRUCTIONS FOR USE (IFU) STATE THAT BASED ON CLINICAL EXPERIENCE, THROMBOSIS AT THE PUNCTURE SITE IS A RISK OR SITUATION ASSOCIATED WITH THE USE OF THE ANGIO-SEAL DEVICE OR VASCULAR ACCESS PROCEDURE, IF THROMBUS AT THE PUNCTURE SITE IS SUSPECTED, THE DIAGNOSIS CAN BE CONFIRMED BY DUPLEX ULTRASOUND. TREATMENT OF THIS EVENT MAY INCLUDE THROMBOLYSIS, PERCUTANEOUS THROMBECTOMY, OR SURGICAL INTERVENTION. THE ANGIO-SEAL DEVICE PATIENT'S INFO GUIDE, WHICH THE PT IS INSTRUCTED TO CARRY WITH THEM FOR 90 DAYS STATES SOME BRUISING OR DISCOMFORT IS COMMON DURING THE HEALING PROCESS AFTER INTRAVASCULAR PROCEDURES; HOWEVER, IF ANY OF THE FOLLOWING SYMPTOMS ARE EXPERIENCED, THE PT IS TO CONTACT THEIR PHYSICIAN IMMEDIATELY AT THE NUMBER LISTED ON THEIR PT INFO CARD; FEVER, BLEEDING, PERSISTENT TENDERNESS IN THE GROIN OR SWELLING, REDNESS AND/OR WARM TO TOUCH, NUMBNESS, TINGLING OR PAIN IN THE EXTREMITY WHEN AMBULATING, RASH, WOUND DRAINAGE, OR ANY OTHER UNUSUAL SYMPTOMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION (PCI), AN 8F ANGIO-SEAL STS PLUS WAS SELECTED FOR USE. A PRE-ANGIOGRAM REVEALED A COMMON FEMORAL ARTERY (CFA) WITH A 5.0 LUMEN DIAMETER WITH MODERATE CALCIFICATION AND ALSO A STENOSED LESION NEAR THE PUNCTURE SITE. THE ANGIO-SEAL WAS DEPLOYED AND THE PT WAS DISCHARGED FROM THE HOSP. ONE WEEK LATER ((B)(6) 2011), THE PT'S LOWER EXTREMITY PULSE (THE SIDE THAT THE ANGIO-SEAL HAD BEEN IMPLANTED IN) BECAME IMPALPABLE. AN INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED, WHICH REVEALED THE ANCHOR LOOSE IN THE ARTERY WITH SOME SPACE BETWEEN THE ANCHOR AND THE SUPERIOR INNER VESSEL WALL. THE ANCHOR WAS SURROUNDED BY THROMBUS, WHICH RESULTED IN 100% VESSEL OCCLUSION. A THROMBECTOMY AND A PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED. THE THROMBUS WAS CLIPPED AWAY BY A FOGARTY CATHETER. THE PT HAS RECOVERED AND WAS SCHEDULED TO BE DISCHARGED FROM THE HOSP ON (B)(6) 2011. THE PHYSICIAN STATED THAT IT WAS HIGHLY POSSIBLE THAT THE EVENT OCCURRED BECAUSE, THE ANCHOR HAD NOT BEEN TIGHTLY APPOSED AGAINST THE VESSEL WALL. HE ALSO STATED THAT BECAUSE OF THE MODERATE STENOTIC LESION NEAR THE PUNCTURE SITE, THAT THE PT SHOULD NOT HAVE BEEN APPLICABLE FOR THE ANGIO-SEAL DEVICE. 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 VASCULAR CLOSURE DEVICE MGB ST. JUDE MEDICAL NA 3120711

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R