BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXERA 2 ACCESS SYSTEM

    MDR report key: 3143004 · Received May 30, 2013

    Report

    Report Number
    3008493244-2013-00021
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 2, 2013
    Manufacturer
    ARSTASIS INC.
    Product Code
    DYB
    PMA / PMN Number
    K123135
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, PRODUCT FAILURE ANALYSIS WAS NOT POSSIBLE. THE PHYSICIAN DID NOT OBTAIN A FLUOROSCOPIC IMAGE OF THE GROIN ACCESS SITE AND IT WAS NOT POSSIBLE TO ASCERTAIN WHETHER THE LOCATION OF ACCESS WAS CORRECT OR TOO HIGH, WHICH COULD HAVE CAUSED THE PSEUDOANEURYSM. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THIS LOT AND NO NONCONFORMING MATERIAL REPORTS HAVE BEEN INITIATED THAT ARE RELATED TO THIS FAILURE MODE. THE AXERA 2 ACCESS SYSTEM INSTRUCTIONS FOR USE (IFU), WAS REVIEWED. THE IFU PROVIDES THE APPROPRIATE INSTRUCTIONS ON DEVICE USAGE, WARNINGS AND PRECAUTIONS; THEREFORE, NO UPDATE IS REQUIRED. BASED ON THE ANALYSIS COMPLETED, THERE IS NO EVIDENCE TO SUGGEST THE DEVICE WAS OUT OF SPECIFICATION. THE ROOT CAUSE, BASED ON AVAILABLE INFO, IS UNK AS IT CANNOT BE DEFINITIVELY DETERMINED.

    Description of Event or Problem · 1

    A DRUG-ELUTING STENT WAS PLACED FOR SINGLE VESSEL DISEASE (PROXIMAL LAD ARTERY). NO TORTUOSITY OR CALCIFICATION WAS NOTED. THE PHYSICIAN ENCOUNTERED SOME RESISTANCE DURING REMOVAL OF THE AXERA DEVICE MOST LIKELY DUE TO SCARRING AT THE GROIN SITE. WHEN THE SHEATH WAS INSERTED INTO THE RIGHT GROIN, A HEMATOMA WAS NOTED AND TREATED WITH MANUAL COMPRESSION PLUS FEMOSTOP. FOLLOWING THE PROCEDURE AND SHEATH REMOVAL A HEMATOMA WAS NOTED AND HEMOSTASIS WAS ACHIEVED WITH MANUAL COMPRESSION AND A FEMOSTOP. AN ULTRASOUND DIAGNOSED A HEMATOMA (4.3X1.0CM) AND THROMBOSED PSEUDOANEURYSM (1.9X0.2CM) WITH PATIENT NECK. THE PATIENT WAS KEPT OVERNIGHT AND A CT SCAN WAS PERFORMED WHICH RULED OUT A RETROPERITONEAL BLEED. THE FOLLOWING DAY A SUBSEQUENT DOPPLER ULTRASOUND EXAMINATION DIAGNOSED A SMALL 1.8X0.8X1.4CM PSEUDOANEURYSM. NO FURTHER TREATMENT WAS ADMINISTERED AND THE PATIENT WAS DISCHARGED AS PLANNED. A SUBSEQUENT ULTRASOUND PERFORMED ON (B)(6) 2013 DIAGNOSED A SMALL PSEUDOANEURYSM (1.72X1.13X1.51 CM) WHICH APPEARED PARTIALLY THROMBOSED AND AN ADJACENT HEMATOMA. THE PATIENT RECOVERED WITH NO FURTHER CLINICAL SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239814 AXERA 2 ACCESS SYSTEM INTRODUCER CATHETER DYB ARSTASIS INC. 13A14008

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization EFFIENT 60MG| HEPARIN 5500 AND 2000 UNITS| PRELUDE SHEATH