BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIO-SEAL DEVICE

    MDR report key: 1241293 · Received November 20, 2008

    Report

    Report Number
    2182269-2008-00329
    Event Type
    Injury
    Date Received
    November 20, 2008
    Report Date
    November 20, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) CAUTION, SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION. THE ANGIO-SEAL DEVICE INSTRUCTION FOR USE (IFU) STATES THAT IF RE-PUNCTURE AT THE SAME LOCATION OF PREVIOUS ANGIO-SEAL DEVICE IS NECESSARY IN LESS THAN OR EQUAL TO 90 DAYS, RE-ENTRY SHOULD BE ONE CENTIMETER PROXIMAL TO THE PREVIOUS ACCESS SITE. 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 PROCEDURES, 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 INFORMATION GUDE, WHICH THE PATIENT 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 PATIENT IS TO CONTACT THEIR PHYSICIAN IMMEDIATELY AT THE NUMBER LISTED ON THEIR PATIENT INFORMATION 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. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) WARNS, TO NOT USE THE ANGIO-SEAL DEVICE IF THE PUNCTURE SITE IS AT OR DISTAL TO THE BIFURCATION OF THE SUPERFICIAL FEMORAL AND PROFUNDA FEMORIS ARTERY. THIS MAY RESULT IN THE ANGIO-SEAL DEVICE ANCHOR CATCHING ON THE BIFURCATION OR BEING POSITIONED INCORRECTLY, AND/OR COLLAGEN DEPOSITION IN THE VESSEL. THESE EVENTS MAY REDUCE BLOOD FLOW THROUGH THE VESSEL LEADING TO SYMPTOMS OF DISTAL ARTERIAL INSUFFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A PRINTED LITERATURE ARTICLE THAT AN ANGIO-SEAL WAS DEPLOYED IN THE RIGHT GROIN POST PROCEDURE. TWENTY-FOUR DAYS LATER, THE PATIENT DEVELOPED A SUDDEN PAIN IN THE RIGHT LEG, WHICH DID NOT SUBSIDE WITH REST. CT ANGIOGRAPHY REVEALED A SUBTOTAL OBSTRUCTION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY. HISTOPATHOLOGICAL EXAMINATION OF THE ENDARTERECTOMY SPECIMEN SHOWED SMALL PARTS OF THE ARTERIAL WALL COVERED BY INTIMAL HYPERPLASIA AND REMNANTS OF COMPLETELY ORGANIZED THROMBUS WITH COMPONENTS OF THE ANGIO-SEAL. IT COULD NOT BE DETERMINED WHETHER THE FACT THAT THE SAME ARTERY WAS PUNCTURED 3 TIMES CONTRIBUTED TO THE OCCLUSION. THE IMPLANT, EXPLANT AND EVENT DATE ARE UNKNOWN; SOMETIME BETWEEN 2005 TO 2008. THE ANGIO-SEAL DEPLOYER IS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R